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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06670274




Registration number
NCT06670274
Ethics application status
Date submitted
21/10/2024
Date registered
1/11/2024

Titles & IDs
Public title
A Dose Escalating Study of HC002 in Healthy Adult Volunteers
Scientific title
A Phase 1 Randomized, Double-blind, Placebo-controlled, First-in-Human Dose Escalation Study of HC002 to Evaluate Safety, Tolerability, and Pharmacokinetics in Healthy Adult Volunteers
Secondary ID [1] 0 0
HC002-001-24
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammatory Disease 0 0
Autoimmune Diseases 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - HC002 SAD
Treatment: Drugs - HC002 MAD
Treatment: Drugs - Placebo

Experimental: Part 1 SAD -

Experimental: Part 2 MAD -

Placebo comparator: Placebo -


Treatment: Drugs: HC002 SAD
Part 1 will enroll 40 participants across 5 cohorts.

Route of administration: Oral Dose interval and frequency: Single oral dose range across 5 cohorts.

Treatment: Drugs: HC002 MAD
Part 2 will enroll 24 participants across 3 cohorts.

Route of administration: Oral Dose interval and frequency: Once daily for 7 days

Treatment: Drugs: Placebo
Matching placebo will be administered across SAD and MAD
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To assess the safety of HC002 by the incidence of adverse events
Timepoint [1] 0 0
SAD- Screening to Day 4 post first dose administration; MAD- screening to Day 11 post first dose administration
Primary outcome [2] 0 0
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
Timepoint [2] 0 0
SAD- Screening to Day 4 post first dose administration; MAD- screening to Day 11 post first dose administration
Primary outcome [3] 0 0
Number of participants with changes to the electrocardiogram (ECG) from baseline recorded as adverse events
Timepoint [3] 0 0
SAD- Screening to Day 4 post first dose administration; MAD- screening to Day 11 post first dose administration
Secondary outcome [1] 0 0
Plasma PK parameters- Maximum plasma concentration (Cmax) after first dose of HC002
Timepoint [1] 0 0
SAD-Samples will be collected on Day 1 to Day 3 post first dose administration; MAD-Samples collected across 11 timepoints on Day 1 and Day 7 post first dose administration
Secondary outcome [2] 0 0
Plasma PK parameters- Time for maximum plasma concentration (Tmax) after first dose of HC002
Timepoint [2] 0 0
SAD-Samples will be collected on Day 1 to Day 3 post first dose administration; MAD-Samples collected across 11 timepoints on Day 1 and Day 7 post first dose administration
Secondary outcome [3] 0 0
Plasma PK parameters-- Area under curve (AUC) after first dose of HC002
Timepoint [3] 0 0
SAD-Samples will be collected on Day 1 to Day 3 post first dose administration; MAD-Samples collected across 11 timepoints on Day 1 and Day 7 post first dose administration
Secondary outcome [4] 0 0
Plasma PK parameters- Apparent clearance (CL/F) after first dose of HC002
Timepoint [4] 0 0
SAD-Samples will be collected on Day 1 to Day 3 post first dose administration; MAD-Samples collected across 11 timepoints on Day 1 and Day 7 post first dose administration
Secondary outcome [5] 0 0
Plasma PK parameters- terminal half-life (t1/2) after first dose of HC002
Timepoint [5] 0 0
SAD-Samples will be collected on Day 1 to Day 3 post first dose administration; MAD-Samples collected across 11 timepoints on Day 1 and Day 7 post first dose administration
Secondary outcome [6] 0 0
Plasma PK parameters- Vz/F (apparent volume of distribution) after first dose of HC002
Timepoint [6] 0 0
SAD-Samples will be collected on Day 1 to Day 3 post first dose administration; MAD-Samples collected across 11 timepoints on Day 1 and Day 7 post first dose administration
Secondary outcome [7] 0 0
Urine PK parameters- Aet1-t2 (amount of analyte that is eliminated in urine from the time point t1 to time point t2) after first dose of HC002
Timepoint [7] 0 0
SAD-Samples will be collected 4 timepoints from Day1 to Day 2 post first dose administration; MAD- Samples collected across 5 time-intervals from Day 1 to Day 7 post first dose administration]
Secondary outcome [8] 0 0
Urine PK parameters- fet1-t2 (fraction of analyte excreted in urine from time point t1 to t2) after first dose of HC002
Timepoint [8] 0 0
SAD-Samples will be collected 4 timepoints from Day1 to Day 2 post first dose administration; MAD- Samples collected across 5 time-intervals from Day 1 to Day 7 post first dose administration
Secondary outcome [9] 0 0
Urine PK parameters-Clearance rate (CLr) after first dose of HC002
Timepoint [9] 0 0
SAD-Samples will be collected 4 timepoints from Day1 to Day 2 post first dose administration; MAD- Samples collected across 5 time-intervals from Day 1 to Day 7 post first dose administration

Eligibility
Key inclusion criteria
1. Male and female participants of 18 to 65 years of age (inclusive)
2. Able to read, understand, sign, and date a written informed consent form (ICF) before study participation at Screening
3. Male participants must agree to use accepted contraceptive regimens during the study and for a period after the last drug administration.
4. Female participants must not be pregnant, intending to become pregnant, or be lactating at any time during the study, and must agree to use accepted contraceptive regimens during the study and for a period after the last drug administration.
5. Body mass index (BMI) between 18.0 and 35.0 kg/m2 (inclusive) at screening and body weight = 50 kg.
6. Judged to be in good health on the basis of medical history, physical examination, and routine laboratory measurements (i.e., without clinically relevant pathology).
7. No clinically significant findings on electrocardiogram (ECG) (12-lead), arterial blood pressure, or heart rate as determined at the discretion of the Investigator.
8. Non-smoker, ex-smoker (being defined as persons who completely stopped smoking cigarettes for at least 6 months), or social smoker (being defined as persons who smoke fewer than the equivalent of 10 nicotine containing products per month).
9. Able to understand and comply with protocol requirements and instructions and likely to complete the study as planned at Screening and upon admission as per PI's judgement.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. History of any illness or condition that, in the opinion of the Investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant.
2. Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with PK of the study drug (except appendectomy, hemorrhoidectomy and simple hernia repair).
3. Regular treatment with prescription or nonprescription medications which, at the discretion of the Investigator, may impact either participant safety during the trial or the study objectives. The continued use of prescribed hormonal contraceptives is permitted, provided use has been stable for 3 months.
4. Consumption of herbal medications, dietary supplements, and specific fruit products (ie, pomello, Seville orange, and grapefruit).
5. History of drug addiction within 2 years before the start of study drug dosing, or a positive test result for drugs of abuse, such as tetrahydrocannabinol (THC), cocaine, amphetamines, barbiturates, benzodiazepines, opiates, methadone, methamphetamines, methylenedioxymethamphetamine (MDMA), and phencyclidine (PCP).
6. History of alcohol addiction within 2 years before the start of study drug dosing, positive test for alcohol, or engages in regular consumption of more than 4 units of alcoholic beverages per day or more than 10 units per week (1 unit of alcohol is equivalent to approximately 1 pint [473 mL] of beer or lager, 1 glass [125 mL] of wine, or 25 mL shot of 40% spirit) before Screening.
7. Participation in a clinical study involving administration of either an investigational or a marketed drug within 30 days, 5 half-lives, or until the expected pharmacodynamic effect has returned to Baseline (whichever is longer) before Screening.
8. Blood donation or a significant loss of blood within 60 days of the start of study drug dosing or donation of more than 1 unit of plasma within 7 days before Screening.
9. Positive result at Screening for any of the following infectious disease tests: hepatitis A virus, hepatitis B virus, hepatitis C virus, and human immunodeficiency virus (HIV-1/-2).
10. Illness within 5 days before the start of study drug dosing ("illness" is defined as an acute [serious or non-serious] condition [e.g., the flu or the common cold]).
11. History of any known relevant allergy/hypersensitivity (including allergy to the study drug or its excipients).
12. Suicidal tendency, history of or disposition to seizures, state of confusion, and/or a diagnosis with a clinically relevant psychiatric disease.
13. Use of immunotherapy within 3 months prior to Screening.
14. Abnormal liver function (ALT > 1.5-times upper limit of normal (ULN) or bilirubin > 1.5-times ULN).
15. Prescence of out-of-range cardiac interval (HR 45 to 100 beats per minute, PR 120 to 220 msec, QRS < 120 msec, and QTcB = 470 msec [female] or = 450 msec [male]) on the Screening ECG or other clinically significant ECG abnormalities as determined by the Investigator.

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 assessing the outcomes
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
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
21/11/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
10/04/2025
Actual
Sample size
Target
64
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
CMAX Clinical Research Pty Ltd - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Holoclara Aus 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
Hung Nguyen
Address 0 0
Country 0 0
Phone 0 0
+1-626-492-0755
Fax 0 0
Email 0 0
info@holoclara.com
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/NCT06670274