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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06595706




Registration number
NCT06595706
Ethics application status
Date submitted
5/09/2024
Date registered
19/09/2024

Titles & IDs
Public title
Evaluating the Safety and Pharmacokinetics of Multiple Ascending Doses of Lucid-21-302 in Healthy Adult Participants
Scientific title
A Phase 1, Randomised, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of Lucid-21-302 in Healthy Adult Participants
Secondary ID [1] 0 0
Lucid-21-302-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heathy Participants 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Lucid-21-302
Treatment: Drugs - Placebo

Experimental: Lucid-21-302 - Multiple ascending dose cohorts

Placebo comparator: Placebo - Multiple ascending dose cohorts


Treatment: Drugs: Lucid-21-302
Capsule containing a small molecule inhibitor of hypercitrullination

Treatment: Drugs: Placebo
Capsule containing only Silicified Microcrystalline Cellulose
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence, severity and relationship of Adverse Events (AEs)
Timepoint [1] 0 0
Up to 15 days
Primary outcome [2] 0 0
Incidence of Serious AEs (SAEs) and suspected unexpected SAEs
Timepoint [2] 0 0
Up to 15 days
Primary outcome [3] 0 0
Number of discontinuations due to AEs
Timepoint [3] 0 0
Up to 15 days
Primary outcome [4] 0 0
Clinically significant changes from baseline in complete blood count
Timepoint [4] 0 0
Up to 15 days
Primary outcome [5] 0 0
Clinically significant changes from baseline in blood coagulation
Timepoint [5] 0 0
Up to 15 days
Primary outcome [6] 0 0
Clinically significant changes from baseline in blood biochemistry
Timepoint [6] 0 0
Up to 15 days
Primary outcome [7] 0 0
Clinically significant changes from baseline in urinalysis
Timepoint [7] 0 0
Up to 15 days
Primary outcome [8] 0 0
Clinically significant changes from baseline in physical exam
Timepoint [8] 0 0
Up to 15 days
Primary outcome [9] 0 0
Clinically significant changes from baseline in systolic blood pressure
Timepoint [9] 0 0
Up to 15 days
Primary outcome [10] 0 0
Clinically significant changes from baseline in diastolic blood pressure
Timepoint [10] 0 0
Up to 15 days
Primary outcome [11] 0 0
Clinically significant changes from baseline in heart rate
Timepoint [11] 0 0
Up to 15 days
Primary outcome [12] 0 0
Clinically significant changes from baseline in respiratory rate
Timepoint [12] 0 0
Up to 15 days
Primary outcome [13] 0 0
Clinically significant changes from baseline in tympanic temperature
Timepoint [13] 0 0
Up to 15 days
Primary outcome [14] 0 0
Clinically significant changes from baseline in 12-lead electrocardiogram (ECG)
Timepoint [14] 0 0
Up to 15 days
Primary outcome [15] 0 0
Clinically significant changes from baseline in patient health questionnaire (PHQ-9)
Timepoint [15] 0 0
Up to 15 days
Primary outcome [16] 0 0
Clinically significant changes from baseline in generalized anxiety disorder questionnaire (GAD7)
Timepoint [16] 0 0
Up to 15 days
Primary outcome [17] 0 0
Clinically significant changes from baseline in Columbia suicide severity rating scale (C-SSRS)
Timepoint [17] 0 0
Up to 15 days
Primary outcome [18] 0 0
Clinically significant changes from baseline in neurological exam
Timepoint [18] 0 0
Up to 15 days
Secondary outcome [1] 0 0
AUC from time zero to 24 hours
Timepoint [1] 0 0
Day1 (pre-dose to 24 hours post-dose)
Secondary outcome [2] 0 0
AUC from time zero to the last non-zero concentration
Timepoint [2] 0 0
Day1 (pre-dose to 24 hours post-dose)
Secondary outcome [3] 0 0
Maximum concentration (Cmax)
Timepoint [3] 0 0
Day1 (pre-dose to 24 hours post-dose)
Secondary outcome [4] 0 0
Time to maximum concentration (Tmax)
Timepoint [4] 0 0
Day1 (pre-dose to 24 hours post-dose)
Secondary outcome [5] 0 0
AUC from time zero to the end of the dosing period
Timepoint [5] 0 0
Day 4 (pre-dose to 24 hours post-dose)
Secondary outcome [6] 0 0
AUC from time zero to the last non-zero concentration
Timepoint [6] 0 0
Day 4 (pre-dose to 24 hours post-dose)
Secondary outcome [7] 0 0
Minimum concentration (Cmin)
Timepoint [7] 0 0
Day 4 (pre-dose to 24 hours post-dose)
Secondary outcome [8] 0 0
Maximum concentration (Cmax)
Timepoint [8] 0 0
Day 4 (pre-dose to 24 hours post-dose)
Secondary outcome [9] 0 0
Time to maximum concentration (Tmax)
Timepoint [9] 0 0
Day 4 (pre-dose to 24 hours post-dose)
Secondary outcome [10] 0 0
AUC from time zero to the last non-zero concentration
Timepoint [10] 0 0
Day 7 (pre-dose to 48 hours post-dose)
Secondary outcome [11] 0 0
Maximum concentration (Cmax)
Timepoint [11] 0 0
Day 7 (pre-dose to 48 hours post-dose)
Secondary outcome [12] 0 0
Time to maximum concentration (Tmax)
Timepoint [12] 0 0
Day 7 (pre-dose to 48 hours post-dose)
Secondary outcome [13] 0 0
Minimum concentration (Cmin)
Timepoint [13] 0 0
Day 7 (pre-dose to 48 hours post-dose)
Secondary outcome [14] 0 0
AUC from time zero to infinity
Timepoint [14] 0 0
Day 7 (pre-dose to 48 hours post-dose)
Secondary outcome [15] 0 0
Average concentration at steady state (Css ave)
Timepoint [15] 0 0
Day 7 (pre-dose to 48 hours post-dose)
Secondary outcome [16] 0 0
AUC from time zero to the end of the dosing period
Timepoint [16] 0 0
Day 7 (pre-dose to 48 hours post-dose)
Secondary outcome [17] 0 0
Residual area
Timepoint [17] 0 0
Day 7 (pre-dose to 48 hours post-dose)
Secondary outcome [18] 0 0
Elimination half-life
Timepoint [18] 0 0
Day 7 (pre-dose to 48 hours post-dose)
Secondary outcome [19] 0 0
Elimination rate constant
Timepoint [19] 0 0
Day 7 (pre-dose to 48 hours post-dose)
Secondary outcome [20] 0 0
Apparent clearance of drug at steady state
Timepoint [20] 0 0
Day 7 (pre-dose to 48 hours post-dose)
Secondary outcome [21] 0 0
Apparent volume of distribution at steady state
Timepoint [21] 0 0
Day 7 (pre-dose to 48 hours post-dose)
Secondary outcome [22] 0 0
AUC accumulation ratio
Timepoint [22] 0 0
Day 1 to Day 7
Secondary outcome [23] 0 0
Maximum concentration (Cmax) accumulation ratio
Timepoint [23] 0 0
Day 1 to Day 7
Secondary outcome [24] 0 0
Trough concentration
Timepoint [24] 0 0
Day 2 to Day 7

Eligibility
Key inclusion criteria
1. Male or female, aged =18 and =60 years (inclusive), with BMI >18.0 and <32.0 kg/m2 and body weight =50.0 kg. Social smokers consuming less than 10 cigarettes per week, with a negative cotinine test at screening and Day -1 will be allowed.
2. Participant is judged by the Investigator to be in generally good health on the basis of medical history, physical examination, or clinical laboratory results during the screening.
3. Pulse between 45 and 100 beats per minute (bpm) in supine position at screening (inclusive)
4. Supine systolic BP between 90 and 160 mmHg, diastolic BP between 50 and 95 mmHg inclusive, at screening. For the purpose of qualifying any given participant for study participation, out-of-range vital signs may be repeated once.
5. Ability to consume standard meals and the ability to fast for at least ten hours.
6. Agree not to have a tattoo or body piercing until the end of the study.
7. Agree not to receive the COVID-19 vaccination or other vaccination from seven days prior to the study drug dose until seven days after study drug administration in the study.
8. Must not be pregnant, breastfeeding (non-lactating), or planning pregnancy.
9. Female participants must have negative serum hCG pregnancy test at screening and negative urine test a check-in.
10. Females of childbearing potential who are sexually active with a non-sterile male partner (sterile male partners are defined as men vasectomised at least 6 months prior to the first study drug administration) must be willing to use one of the following acceptable contraceptive methods throughout the study and for at least 1 month after the last study drug administration:

a. Simultaneous use of intrauterine contraceptive device with or without hormone release system placed at least 4 weeks prior to the first study drug administration; and a condom for the male partner. Oral contraceptives are not allowed.
11. Females of non-childbearing potential must be:

1. Post-menopausal (absence of menses for at least 12 months prior to the first study drug administration) with confirmation of the post menopausal status by documented FSH level =40 mIU/mL; or
2. Surgically sterile (complete hysterectomy or bilateral oophorectomy at least 3 months prior to the first study drug administration).
12. Female participants must be willing not to donate ova for 90 days after the last dose
13. Male participants who are not vasectomised for at least 6 months prior to dosing and who are sexually active with a female partner of childbearing potential must be willing to use one of the following acceptable contraceptive methods from the first dose and for 90 days after the last dose:

a. Simultaneous use of condom and hormonal contraceptive (e.g., oral, patch, depot injection, implant, vaginal ring, intrauterine device) or non-hormonal intrauterine device used for at least 4 weeks prior to sexual intercourse for the female partner;
14. All male participants (including men who have had a vasectomy) must agree to use a condom from the first dose and for 90 days after the last dose.
15. Male participants must be willing not to donate sperm for 90 days after the last dose.
16. Willing and able to adhere to all study requirements, including willingness to remain in the study unit for the entire duration of the confinement period.
17. Participant has a good venous access.
18. Able to understand the study procedures and provide signed and dated participant informed consent form (ICF) to participate in the study prior to screening.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria:

1. History of any clinically significant gastrointestinal, renal, hepatic (except cholecystectomy), neurologic, hematologic, endocrine, oncologic, pulmonary (except resolved childhood astma), immunologic, or cardiovascular disease or other condition which would jeopardize safety or impact validity of results (in the opinion the Investigator); history of common medical conditions such as depression (non-hospitalised, but potentially medicated in the past), migraine or Gilbert syndrome will not be allowed unless the exemption will be provided by the Investigator.
2. Participant has any documented clinically significant infection, injury, or illness within 1 month prior to screening.
3. Participant has any documented history of, or currently active, seizure disorder (any seizure including infantile seizures), or history of clinically significant head injury based on the opinion of the Investigator.
4. Participants who have a history of surgery within 6 months prior to screening, or who have a plan of surgery during the study. Small surgeries such as dental operation, biopsies and non-invasive surgeries may be allowed at Investigator discretion.
5. Liver function test results elevated more than 1.5-fold above the upper limit of normal (ULN) for gamma glutamyl transferase (GGT), bilirubin (total, conjugated and unconjugated), alkaline phosphatase (ALP), aspartate aminotransferase (AST) or alanine aminotransferase (ALT). Volunteers with ALP and/or ALT/AST above the limits specified may be included, at the discretion of the Investigator, if the levels are unaccompanied by clinical signs and are determined to be normal variants; Testing for any out-of-range values may be repeated once at the discretion of the Investigator.
6. A calculated creatinine clearance of < 60 mL/minute at Screening according to the equation using Cockcroft and Gault.

Testing for any out-of-range laboratory tests values may be repeated once at the discretion of the Investigator.
7. Participant has an active malignancy of any type or has been diagnosed with cancer within 5 years prior to screening (excluding squamous or basal cell carcinoma of the skin).
8. Any laboratory test results deemed clinically significant by the Investigator or positive test serology test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen and antibody at screening.

Testing for any out-of-range laboratory tests values may be repeated once at the discretion of the Investigator.
9. History of inherent cardiac abnormalities based on the opinion of the Investigator.
10. Clinically significant ECG abnormalities in supine position defined at the Investigator discretion (Fridericia's corrected QT interval [QTcF] >440 ms for males and >460 ms for females), PR >210 ms, QRS interval > 120 ms at screening.

Testing for any out-of-range values may be repeated once at the discretion of the Investigator.
11. Clinically significant bradycardia or tachycardia in supine position defined at the Investigator discretion as resting heart rate (HR) <44 bmp or > 101 bpm, respectively.

Testing for any out-of-range values may be repeated once at the discretion of the Investigator.
12. Positive urine drug screen, urine cotinine and alcohol breath test and at screening or check-in.

Testing may be repeated once at the discretion of the Investigator.
13. History or presence of food allergies and dietary restrictions, which, in the opinion of the Investigator, would prevent the participant from participating in the study.
14. Known history or presence of severe allergic reactions (e.g., anaphylactic reactions, angioedema), which, in the opinion of the Investigator, would prevent the participant from participating in the study.
15. Participants with a score = 10 for the Modified Patient Health Questionnaire (PHQ-9) or the Modified Generalized Anxiety Disorder 7-item (GAD-7) or Columbia Suicide Severity Rating Scale (C-SSRS)
16. History of significant drug abuse (as per Investigator's discretion) such as cocaine, phencyclidine (PCP), crack, opioid derivatives including heroin, and amphetamine derivatives within 1 year prior to screening and throughout the study.
17. Use of marijuana (directly or indirectly) within 90 days prior to drug administration and during the course of the study.
18. History of significant alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to the screening visit that exceeds 14 units of alcohol per week (1 unit = 150 mL of wine, 375 mL of mid strength beer, or 30 mL of distilled alcohol 40%).
19. Use of medications for the timeframes specified below, with the exception of medications exempted by the Investigator on a case-by-case basis because they are judged unlikely to affect the PK profile of the study drug or participant safety (e.g., topical drug products without significant systemic absorption):

1. Prescription medications (except for allowed contraceptives) within 14 days prior to the first dose until end of the study;
2. Monoamine oxidase inhibitors (MAOIs) within 28 days prior to dosing;
3. Over-the-counter products and natural health products (including herbal remedies such as St. John's wort, homeopathic and traditional medicines), and antacid preparations within 30 days prior to the first dose up to end of study. Vitamins and dietary supplements used as nutritional supplements in non-therapeutic doses (judged by the qualified Investigator or designee) must be stopped at least 14 days before dosing and during the study.
4. Any drugs known to induce or inhibit hepatic and renal drug metabolism within 30 days prior to the first dose and during the study.
5. Use of any enzyme-modifying drugs and/or other products, including strong inhibitors of cytochrome P450 (CYP) enzymes (e.g., cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem and HIV antivirals) and strong inducers of CYP enzymes (e.g., barbiturates, carbamazepine, glucocorticoids, phenytoin, St. John´s Wort, and rifampicin) in the previous 30 days before study drug administration.
20. Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days (or a minimum of 5 half-lives, whichever is longer) prior to the first dose, administration of a biological product in the context of a clinical research study within 90 days prior to the first dose, or concomitant participation in an investigational study involving no drug or device administration.
21. Donation of plasma within 7 days prior to dosing or donation or loss of 500 mL or more of whole blood within 56 days prior to Day -1.
22. Any reason which, in the opinion of the Investigator, would prevent the participant from participating in the study

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/09/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2025
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Marylan
Recruitment hospital [1] 0 0
Cmax Clinical Research - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Huge Biopharma Australia Pty Ltd
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Michele De Sciscio, MD
Address 0 0
Country 0 0
Phone 0 0
+61 (0) 870887900
Fax 0 0
Email 0 0
Michele.DeSciscio@sa.gov.au
Contact person for scientific queries

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

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06595706