Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12624001426572
Ethics application status
Approved
Date submitted
13/11/2024
Date registered
5/12/2024
Date last updated
5/12/2024
Date data sharing statement initially provided
5/12/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A Randomised, Double-Blind, Placebo-Controlled, First-in-Human Study of Orally Administered ZE75-0267 to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of ZE75-0267 in Healthy Volunteers
Scientific title
A Randomised, Double-Blind, Placebo-Controlled, First-in-Human Study of Orally Administered ZE75-0267 to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of ZE75-0267 in Healthy Volunteers
Secondary ID [1] 313019 0
ZE75-0267-0001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's Disease 335217 0
Condition category
Condition code
Neurological 331769 331769 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a double-blind, randomised, placebo-controlled study evaluating the safety, tolerability, and pharmacokinetics (PK) of ZE75-0267. The study will be conducted in 2 parts: a single ascending dose (SAD) part (Part A) at up to 5 dose levels and a multiple ascending dose (MAD) part (Part B) at up to 3 dose levels. Evaluation of dose levels will be conducted in a sequential fashion with lower dose levels evaluated first in the sequence. Participants will only be allowed to enroll in either Part A or B of the study.

Part A: Each cohort will enroll 8 participants with 6 participants randomized to receive ZE75-0267 and 2 participants randomized to receive placebo on Day 1 under fasted conditions. There will be 5 cohorts and ZE75-0267 oral capsules will be administered at the following dose levels:

•SAD Cohort 1: 50 mg
•SAD Cohort 2: 100 mg
•SAD Cohort 3: 300 mg
•SAD Cohort 4: 600 mg
•SAD Cohort 5: 900 mg

The decision to escalate between dose levels in study Part A (SAD) will be based on review of the safety data from the current and the previous cohort(s) and trailing PK data by the SRC.

SAD Cohort 3 – food effect cohort: Single oral dose of ZE75-0267 or placebo administered on Day 1 under fasted conditions and another single oral dose administered on Day 15 under fed conditions (total of 2 doses). After an overnight fast of 10 hours, a high fat, high calorie meal will be consumed consisting of:
1. Two eggs fried in butter
2. Two rashers of bacon
3. Two slices of toast with 16 g butter per slice
4. 125 g of hash browns
5. 240 mL of full cream milk

Part B: ZE75-0267 oral capsule will be administered once daily for 14 days at up to 3 dose levels (3 cohorts) in the range of 100 mg to up to 600 mg (total daily dose; actual dosage to be determined based on data from Part 1 and the preceding cohorts in Part 2). Each cohort will enroll 8 participants with 6 participants randomized to receive ZE75-0267 and 2 participants randomized to receive placebo.

Study drug will be administered at the study site by trained study site personnel to ensure compliance.
Intervention code [1] 329568 0
Treatment: Drugs
Comparator / control treatment
Capsules of matching appearance and formulation to the investigational product, however without the ZE75-0267 active ingredient, will be administered as placebo in this study.
Control group
Placebo

Outcomes
Primary outcome [1] 339425 0
To assess the safety and tolerability of single oral doses of ZE75-0267 in healthy adult volunteers (Part A SAD Cohorts 1, 2, 4, 5 only)
Timepoint [1] 339425 0
Adverse events will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5-point scale and assessed continuously as observed and reviewed daily from Screening until Day 8 End of Study/Early Termination Visit (EoS/ETV).

Body weight will be assessed using digital weigh scale at Screening, Day -1, Day 1 6 hrs post-dose, Day 2 24 hrs post-dose, Day 3 48 hrs post-dose and Day 8 (EoS/ETV).

Vital signs (blood pressure assessed using digital sphygmomanometer, heart rate and respiratory rate assessed using pulse oximeter, and temperature assessed using digital thermometer) will be assessed from Screening, Day -1, pre-dose Day 1, 0.08, 0.25, 0.5, 1, 2, 3, 4, 6 and 8 hrs post-dose, Day 2 24 hrs post-dose, Day 3 48 hrs post-dose, Day 4 72 hrs post-dose and Day 8 (EoS/ETV).

ECG's will be conducted in triplicate at Screening only, single readings will be conducted from Day -1, pre-dose Day 1 1, 6 hrs post-dose, Day 2 24 hrs post-dose, Day 4 72 hrs post-dose and Day 8 (EoS/ETV).

Clinical laboratory blood and urine samples will be collected at Screening, Day -1, pre-dose Day 1 (urinalysis), Day 1 6 hrs post-dose, Day 2 24 hrs post-dose, Day 3 48 hrs post-dose and Day 8 (EoS/ETV).
Primary outcome [2] 339426 0
To assess the safety and tolerability of multiple oral doses of ZE75-0267 in healthy adult volunteers (Part A SAD Cohort 3 only )
Timepoint [2] 339426 0
Adverse events will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5-point scale and assessed continuously as observed and reviewed daily from Screening until Day 22 End of Study/Early Termination Visit (EoS/ETV).

Body weight will be assessed using digital weigh scale at Screening, Day -1, Day 1 6 hrs post-dose, Day 2 24 hrs post-dose, Day 3 48 hrs post-dose, Day 16 24 hrs post-second dose, Day 17 48 hrs post-second dose and Day 22 (EoS/ETV).

Vital signs (blood pressure assessed using digital sphygmomanometer, heart rate and respiratory rate assessed using pulse oximeter, and temperature assessed using digital thermometer) will be assessed from Screening, Day -1, pre-dose Day 1, 0.08, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose, Day 2 24 hrs post-dose, Day 3 48 hrs post-dose, Day 4 72 hrs post-dose, pre-dose Day 15 0.08, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose, Day 16 24 hrs post-second dose, Day 17 48 hrs post-second dose, Day 18 72 hrs post-second dose and Day 22 (EoS/ETV).

ECG's will be conducted in triplicate at Screening only, single readings will be conducted from Day -1, pre-dose Day 1 1 and 6 hrs post-dose, Day 2 24 hrs post-dose, Day 4 72 hrs post-dose, pre-dose Day 15 1 and 6 hrs post-second dose, Day 16 24 hrs post-second dose, Day 18 72 hrs post-second dose and Day 22 (EoS/ETV).

Clinical laboratory blood and urine samples will be collected at Screening, Day -1, pre-dose Day 1 (urinalysis), Day 1 6 hrs post-dose, Day 2 24 hrs post-dose, Day 4 48 hrs post-dose, Day 14 post-dose, pre-second dose Day 15 6 hrs post-second dose, Day 16 24 hrs post-second dose, Day 17 48 hrs post-second dose and Day 22 (EoS/ETV).
Primary outcome [3] 339707 0
To assess the safety and tolerability of multiple oral doses of ZE75-0267 in healthy adult volunteers (Part B MAD Cohorts only)
Timepoint [3] 339707 0
Adverse events will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5-point scale and assessed continuously as observed and reviewed daily from Screening until Day 21 End of Study/Early Termination Visit (EoS/ETV).

Body weight will be assessed using digital weigh scale at Screening, Day -1, Day 1 6 hrs post-dose, Day 2 24 hrs post-dose, Day 5 post-dose, Day 15 24 hrs post-second dose and Day 21 (EoS/ETV).

Vital signs (blood pressure assessed using digital sphygmomanometer, heart rate and respiratory rate assessed using pulse oximeter, and temperature assessed using digital thermometer) will be assessed from Screening, Day -1, pre-dose Day 1, 0.08, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose, Day 2 24 hrs post-dose, Day 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, pre-dose Day 14 0.08, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-second dose, Day 15 24 hrs post-second dose, Day 16 48 hrs post-second dose, Day 17 72 hrs post-second dose and Day 21 (EoS/ETV).

ECG's will be conducted in triplicate at Screening only, single readings will be conducted from Day -1, pre-dose Day 1 1 and 6 hrs post-dose, Day 2 24 hrs post-dose, Day 5 post-dose, Day 10 post-dose, pre-dose Day 14 1 and 6 hrs post-second dose, Day 15 24 hrs post-second dose, Day 16 48 hrs post-second dose, Day 17 72 hrs post-second dose and Day 21 (EoS/ETV).

Clinical laboratory blood and urine samples will be collected at Screening, Day -1, pre-dose Day 1 (urinalysis), Day 1 6 hrs post-dose, Day 2 24 hrs post-dose, Day 5 post-dose, Day 10 psot-dose, pre-second dose (urinalysis) Day 14, Day 15 24 hrs post-second dose, and Day 21 (EoS/ETV).
Secondary outcome [1] 439942 0
To assess the PK, including plasma concentrations, of ZE75-0267 in plasma following administration of single oral doses in healthy adult volunteers (Part A SAD Cohorts 1, 2, 4, 5 only)
Timepoint [1] 439942 0
Blood plasma samples will be collected pre-dose Day 1, 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose, Day 2 24 & 36 hrs post-dose, Day 3 48 hrs post-dose, Day 4 72 hrs post-dose and Day 8 (EoS/ETV).
Secondary outcome [2] 439943 0
To assess the PK, including plasma concentrations, of ZE75-0267 in plasma following administration of multiple oral doses in healthy adult volunteers (Part B MAD Cohorts only)
Timepoint [2] 439943 0
Blood plasma samples will be collected pre-dose Day 1, 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose, Day 2 24 hrs post-dose, pre-dose on Days 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 and Day 13, pre-dose Day 14, 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose, Day 15 24 hrs post-dose, Day 16 48 hrs post-dose, Day 17 72 hrs post-dose and Day 21 (EoS/ETV).
Secondary outcome [3] 439944 0
To assess the PK, including plasma concentrations, of ZE75-0267 in plasma following administration of multiple oral doses in healthy adult volunteers (Part A SAD Cohort 3 only)
Timepoint [3] 439944 0
Blood plasma samples will be collected pre-dose Day 1, 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose, Day 2 24 and 36 hrs post-dose, Day 3 48 hrs post-dose, Day 4 72 hrs post-dose, Day 8 post-dose, pre-dose Day 15, 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose, Day 16 24 and 36 hrs post-dose, Day 17 48 hrs post-dose, Day 18 72 hrs post-dose and Day 22 (EoS/ETV).
Secondary outcome [4] 440955 0
To evaluate the concentration of ZE75-0267 in cerebrospinal fluid (CSF)
Timepoint [4] 440955 0
CSF sampling in Part A will involve collection of CSF from one SAD cohort (either SAD Cohort 3 [Period 1 fasted], 4 or 5) at one post-dose timepoint per participant. The day and timepoint of the CSF collection will be decided based on emerging PK data from preceeding SAD cohorts, if deemed necessary to optimise data collection and safety.
CSF sampling in Part B will involve collection of CSF from up to 2 MAD cohorts (MAD Cohort 2 and/or 3) at one post-dose timepoint per participant. The day and timepoint of the CSF collection will be decided based on emerging PK data from Part A and preceding MAD cohorts, if deemed necessary to optimise data collection and safety.
Secondary outcome [5] 440961 0
Exploratory Outcome: To assess target engagement in CSF
Timepoint [5] 440961 0
CSF sampling in Part A will involve collection of CSF from one SAD cohort (either SAD Cohort 3 [Period 1 fasted], 4 or 5) at one post-dose timepoint per participant. The day and timepoint of the CSF collection will be decided based on emerging PK data from preceeding SAD cohorts, if deemed necessary to optimise data collection and safety.
CSF sampling in Part B will involve collection of CSF from up to 2 MAD cohorts (MAD Cohort 2 and/or 3) at one post-dose timepoint per participant. The day and timepoint of the CSF collection will be decided based on emerging PK data from Part A and preceding MAD cohorts, if deemed necessary to optimise data collection and safety.
Secondary outcome [6] 440990 0
Exploratory Outcome: To assess the effect of food on the PK of ZE75-0267 following administration of a single oral dose in healthy adult volunteers (Part A, SAD Cohort 3 only)
Timepoint [6] 440990 0
Blood plasma samples will be collected pre-dose Day 1, 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose, Day 2 24 and 36 hrs post-dose, Day 3 48 hrs post-dose, Day 4 72 hrs post-dose, Day 8 post-dose, pre-dose Day 15, 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose, Day 16 24 and 36 hrs post-dose, Day 17 48 hrs post-dose, Day 18 72 hrs post-dose and Day 22 (EoS/ETV).
Secondary outcome [7] 442176 0
Exploratory Outcome: To assess the pharmacodynamics (PD) of single oral doses of ZE75-0267 and its relationship to study drug concentrations. (Part A SAD Cohorts 1, 2, 4, 5 only)
Timepoint [7] 442176 0
Blood plasma samples will be collected pre-dose Day 1 - 1, 3, 8 and 12 hrs post-dose and Day 2 24 hrs post-dose.
Secondary outcome [8] 442177 0
Exploratory Outcome: To assess the pharmacodynamics (PD) of single oral doses of ZE75-0267 and its relationship to study drug concentrations. (Part A SAD Cohorts 1, 2, 4, 5 only)
Timepoint [8] 442177 0
Blood plasma will be collected pre-dose Day 1 - 1, 3, 8 and 12 hrs post-dose and Day 2 24 hrs post-dose.
Secondary outcome [9] 442178 0
Exploratory Outcome: To assess the pharmacodynamics (PD) of single oral doses of ZE75-0267 and its relationship to study drug concentrations. (Part A SAD Cohorts 1, 2, 4, 5 only)
Timepoint [9] 442178 0
Urine samples will be collected pre-dose Day 1 and Day 2 24 hrs post-dose.
Secondary outcome [10] 442179 0
Exploratory Outcome: To assess the pharmacodynamics (PD) of multiple oral doses of ZE75-0267 and its relationship to study drug concentrations. (Part B MAD Cohorts only)
Timepoint [10] 442179 0
Blood plasma will be collected pre-dose Day 1 - 1, 3, 8 and 12 hrs post-dose, Day 2 24 hrs post-dose, 1, 3, 8 and 12 hrs post-second dose, pre-second dose Day 14 and Day 15 24 hrs post-second dose.
Secondary outcome [11] 442180 0
Exploratory Outcome: To assess the pharmacodynamics (PD) of multiple oral doses of ZE75-0267 and its relationship to study drug concentrations. (Part B MAD Cohorts only)
Timepoint [11] 442180 0
Blood plasma will be collected pre-dose Day 1 - 1, 3, 8 and 12 hrs post-dose, Day 2 24 hrs post-dose, 1, 3, 8 and 12 hrs post-second dose, pre-second dose Day 14 and Day 15 24 hrs post-second dose.
Secondary outcome [12] 442181 0
Exploratory Outcome: To assess the pharmacodynamics (PD) of multiple oral doses of ZE75-0267 and its relationship to study drug concentrations. (Part B MAD Cohorts only)
Timepoint [12] 442181 0
Urine samples will be collected pre-dose Day 1 and pre-second dose Day 14.
Secondary outcome [13] 442184 0
Exploratory Outcome: To assess the pharmacodynamics (PD) of multiple oral doses of ZE75-0267 and its relationship to study drug concentrations. (Part A SAD Cohort 3)
Timepoint [13] 442184 0
Blood plasma will be collected pre-dose Day 1 - 1, 3, 8 and 12 hrs post-dose, Day 2 24 hrs post-dose, pre-second dose Day 15 - 1, 3, 8 and 12 hrs post-second dose and Day 16 24 hrs post-second dose.
Secondary outcome [14] 442185 0
Exploratory Outcome: To assess the pharmacodynamics (PD) of multiple oral doses of ZE75-0267 and its relationship to study drug concentrations. (Part A SAD Cohort 3)
Timepoint [14] 442185 0
Blood plasma will be collected pre-dose Day 1 - 1, 3, 8 and 12 hrs post-dose, Day 2 24 hrs post-dose, pre-second dose Day 15 - 1, 3, 8 and 12 hrs post-second dose and Day 16 24 hrs post-second dose.
Secondary outcome [15] 442186 0
Exploratory Outcome: To assess the pharmacodynamics (PD) of multiple oral doses of ZE75-0267 and its relationship to study drug concentrations. (Part A SAD Cohort 3)
Timepoint [15] 442186 0
Urine samples will be collected pre-dose Day 1, Day 2 24 hrs post-dose, pre-second dose Day 15 and Day 16 24 hrs post-second dose.

Eligibility
Key inclusion criteria
1. Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
2. Adult males and females, 18 to 65 years of age (inclusive) at screening.
3. Body mass index (BMI) greater than or equal to 18.0 and less than or equal to 32.0 kg/m2, with a body weight (to 1 decimal place) greater than or equal to 50.0 kg for males or greater than or equal to 45 kg for females at screening.
4. Medically healthy without clinically significant abnormalities (in the opinion of the PI [or delegate]) at the screening visit and prior to dosing at the timepoints indicated in the Schedule of Assessments, including:
a. Physical examination without any clinically significant findings in the opinion of the investigator.
b. Systolic blood pressure in the range of 90 mm Hg to 160 mm Hg; diastolic blood pressure in the range of 50 mm Hg to 95 mm Hg.
c. HR in the range of 40 to 100 bpm after 5 minutes in a supine or semi-supine position
d. Body temperature (tympanic or oral) in the range 35.5°C to 37.5°C (inclusive).
e. Triplicate 12-lead ECG (taken after the volunteer has been supine or semi-supine for at least 5 minutes) with a QTcF less than or equal to 450 msec for males and less than or equal to 470 msec for females and no clinically significant abnormalities.
f. No clinically significant findings in serum chemistry, haematology, coagulation, and urinalysis tests.
5. Female volunteers, must:
a. Must be of non-childbearing potential i.e., surgically sterilised (hysterectomy, bilateral salpingectomy, bilateral oophorectomy) at least 6 weeks before the screening visit or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause and a follicle-stimulating hormone (FSH) level consistent with postmenopausal status, per local laboratory guidelines), or
b. If of childbearing potential, must:
i. Have a negative pregnancy test at the screening visit and on admission to the study site on Day -1.
ii. Agree not to attempt to become pregnant or donate ova from signing the consent form until at least 30 days after the last dose of study drug.
iii. Agree to use adequate contraception (defined as use of a condom by the male partner combined with use of a highly effective method of contraception) from one month prior to screening until at least 30 days after the last dose of study drug, if not exclusively in a same-sex relationship or abstinent as a committed lifestyle
6. Male volunteers, must:
a. Agree not to donate sperm from signing the consent form until at least 90 days after the last dose of study drug.
b. If engaging in sexual intercourse with a female partner who could become pregnant, agree to use adequate contraception (defined as use of a condom combined with use of a highly effective method of contraception) from signing the consent form until at least 90 days after the last dose of study drug.
c. If engaging in sexual intercourse with a female partner who is not of childbearing potential or a same-sex partner, agree to use a condom from signing the consent form until at least 3 days after the last dose of study drug.
7. Have suitable venous access for blood sampling.
8. Be willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.
9. [Part A SAD and Part B MAD, select cohorts undergoing CSF collection] Participant is willing and able to undergo lumbar puncture and have no contraindications to the procedure.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Known hypersensitivity to the study drug or any of the study drug ingredients.
2. History of anaphylaxis or other significant allergy which, in the opinion of the PI (or delegate), would interfere with the volunteer’s ability to participate in the study.
3. History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, psychiatric, or neurological disease/disorder, including any acute illness, within the past 3 months determined by the PI (or delegate) to be clinically relevant.
4. History of surgery or hospitalisation within 3 months prior to screening, or surgery planned during the study.
5. Any history of malignant disease in the last 10 years (excludes surgically resected skin squamous cell or basal cell carcinoma).
6. Presence of clinically relevant immunosuppression from, but not limited to, immunodeficiency conditions such as common variable hypogammaglobulinemia.
7. History of risk factors for torsade de pointes (including a family history of long QT syndrome or sudden cardiac death) or a known arrythmia.
8. Presence or having sequelae of gastrointestinal, liver (including Gilbert’s syndrome), kidney, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
9. Liver function test results elevated >1.5-fold above the ULN for gamma glutamyl transferase (GGT), bilirubin (total, conjugated and unconjugated), ALP, AST or ALT. Participants with elevated GGT, ALP, AST and/or ALT above the limits specified may be included, at the discretion of the PI (or delegate), if the levels are unaccompanied by clinical signs and are determined to be normal variants.
10. Estimated creatinine clearance (CrCl) < 60 mL/min using the Cockcroft-Gault formula or serum creatinine >1.5-fold above the ULN.
11. A history of or positive test results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies at the screening visit.
12. Positive drugs of abuse test, carbon monoxide breath test or alcohol breath test results at the screening visit and/or on admission to the study site on Day -1.
13. Regular consumption of more than 10 standard alcoholic drinks/week and/or more than 4 standard alcoholic drinks on any one day, where 1 standard drink is 10 g of pure alcohol and is equivalent to 285 mL beer [4.9% Alc/Vol], 100 mL wine [12% Alc/Vol], or 30 mL spirit [40% Alc/Vol]).
14. Volunteer smokes more than 5 cigarettes or equivalent nicotine-containing products per week, and/or the volunteer is unwilling to abstain from smoking or the use of nicotine-containing products for 72 hours prior to check-in on Day -1 and throughout the study.
Note: 1 average cigar equals approx. 5 average cigarettes; 1 average pipe session equals approx. 5 average cigarettes, 1 average nicotine liquid vape session equals 1 average e-cigarette equals 1 average cigarette.
15. Females who are breastfeeding or planning to breastfeed.
16. Unable to swallow oral medication.
17. Use of any prescription or over-the-counter medication (including herbal products, diet aids, vitamins, and hormone supplements) within 10 days or 5 half-lives of the medication (whichever is longer) prior to the first dose of study drug, except use of contraceptives, the use of paracetamol (up to 2 g per day) for no more than 3 consecutive days and the use of ibuprofen (up to 1.2 g per day) for no more than 3 consecutive days.
18. In addition, participants must not take systemic immunosuppressive (e.g., corticosteroids, methotrexate, azathioprine, cyclosporine) or immunomodulating medications (e.g., interferon) within 28 days or 5 half-lives of individual agent (whichever is longer) prior to dosing and during the study.
19. Use of or plans to use agents (e.g., grapefruit and grapefruit products) that have clinically significant interaction with CYP3A4 or the use of any medications that could have a significantly impact on organ function (e.g., barbiturates, omeprazole, cimetidine) during the study or within 5 half-lives of individual agent or within 7 days (whichever is longer) prior to dosing.
20. Current infection that requires systemically absorbed antibiotic, antifungal, antiparasitic or antiviral medication within 10 days prior to first dose of study drug.
21. Use of any vaccinations within 30 days prior to screening.
22. Donation of blood or plasma within 30 days prior to first dose of study drug, or loss of whole blood of more than 500 mL within 30 days prior to first dose of study drug, or receipt of a blood transfusion within 1 year of the first dose of study drug.
23. Participation in any clinical study of an investigational drug or investigational device within 30 days or 5 half-lives of the investigational drug (whichever is longer) prior to screening.
24. Any other condition or prior therapy that in the opinion of the PI (or delegate) would make the volunteer unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likelihood of noncompliance with any study requirements.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All study participants who sign an informed consent form (ICF) at screening will receive a unique sequential number (i.e., a Screening Number).
Participants who meet the study eligibility criteria will be assigned a randomization number sequentially on Day -1 or pre-dose on Day 1, which corresponds to a study treatment (ZE75-0267 or placebo). Sealed participant-specific code break envelopes will be produced by the unblinded statistician(s) and will be retained at the clinical facility in a secure, accessible location.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation to ZE75-0267 or placebo will be performed using a block randomization algorithm and will be documented in the study randomization schedule.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/12/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
64
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 27246 0
Scientia Clinical Research - Randwick
Recruitment postcode(s) [1] 43327 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 317460 0
Commercial sector/Industry
Name [1] 317460 0
Brenig Therapeutics AU Pty Ltd. (subsidiary of Brenig Therapeutics )
Country [1] 317460 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Brenig Therapeutics AU Pty Ltd. (subsidiary of Brenig Therapeutics )
Address
Country
Australia
Secondary sponsor category [1] 319750 0
Commercial sector/Industry
Name [1] 319750 0
Avance Clinical Pty Ltd
Address [1] 319750 0
Country [1] 319750 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316175 0
Bellberry Human Research Ethics Committee B
Ethics committee address [1] 316175 0
Ethics committee country [1] 316175 0
Australia
Date submitted for ethics approval [1] 316175 0
23/10/2024
Approval date [1] 316175 0
21/11/2024
Ethics approval number [1] 316175 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 137034 0
Dr Christopher Argent
Address 137034 0
Scientia Clinical Research, Bright Building, Level 5, Corner High and Avoca Street, Randwick, NSW 2031
Country 137034 0
Australia
Phone 137034 0
+61 2 9382 5844
Fax 137034 0
Email 137034 0
christopher.argent@scientiaclinicalresearch.com.au
Contact person for public queries
Name 137035 0
Christopher Argent
Address 137035 0
Scientia Clinical Research, Bright Building, Level 5, Corner High and Avoca Street, Randwick, NSW 2031
Country 137035 0
Australia
Phone 137035 0
+61 2 9382 5844
Fax 137035 0
Email 137035 0
christopher.argent@scientiaclinicalresearch.com.au
Contact person for scientific queries
Name 137036 0
Christopher Argent
Address 137036 0
Scientia Clinical Research, Bright Building, Level 5, Corner High and Avoca Street, Randwick, NSW 2031
Country 137036 0
Australia
Phone 137036 0
+61 2 9382 5844
Fax 137036 0
Email 137036 0
christopher.argent@scientiaclinicalresearch.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.