Inflammatory DiseasePhase 1NCT06670274
A Dose Escalating Study of HC002 in Healthy Adult Volunteers
A Phase 1 study testing HC002 SAD and HC002 MAD in people with Inflammatory Disease and Autoimmune Diseases, run by Holoclara Aus Pty Ltd at 1 site in Australia.
Trial summary
This is a first-in-human (FIH) study to evaluate the safety, tolerability, and pharmacokinetics (PK) of single and multiple ascending oral doses of HC002 in healthy adult participants. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Disease, Autoimmune Diseases
- What is being tested?
- HC002 SAD and HC002 MAD
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteAustralia
- Study dates
- 21 Nov 2024to 7 May 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female participants of 18 to 65 years of age (inclusive)
- Able to read, understand, sign, and date a written informed consent form (ICF) before study participation at Screening
- Male participants must agree to use accepted contraceptive regimens during the study and for a period after the last drug administration.
- 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.
- Body mass index (BMI) between 18.0 and 35.0 kg/m2 (inclusive) at screening and body weight ≥ 50 kg.
- Judged to be in good health on the basis of medical history, physical examination, and routine laboratory measurements (i.e., without clinically relevant pathology).
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- No clinically significant findings on electrocardiogram (ECG) (12-lead), arterial blood pressure, or heart rate as determined at the discretion of the Investigator.
- 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).
- 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.
Who cannot join
- 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.
- Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with PK of the study drug (except appendectomy, hemorrhoidectomy and simple hernia repair).
- 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.
- Consumption of herbal medications, dietary supplements, and specific fruit products (ie, pomello, Seville orange, and grapefruit).
- 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).
- 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.
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- 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.
- 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.
- 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).
- 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]).
- History of any known relevant allergy/hypersensitivity (including allergy to the study drug or its excipients).
- Suicidal tendency, history of or disposition to seizures, state of confusion, and/or a diagnosis with a clinically relevant psychiatric disease.
- Use of immunotherapy within 3 months prior to Screening.
- Abnormal liver function (ALT > 1.5-times upper limit of normal (ULN) or bilirubin > 1.5-times ULN).
- 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.
Trial locations and contacts
1 site in 1 country.
Australia1 site
CMAX Clinical Research Pty Ltd
Adelaide, South Australia, 5000
About this study
Official 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
This is a first-in-human (FIH) study to evaluate the safety, tolerability, and pharmacokinetics (PK) of single and multiple ascending oral doses of HC002 in healthy adult participants.
Read the detailed description
This is a single center, randomized, double-blind, placebo-controlled, two-part study to evaluate the safety, tolerability, and PK of single (Part 1) and multiple (Part 2) oral doses of HC002.
The study will enroll approximately 56 participants across 2 parts. In Part 1 (SAD), there will be 4 cohorts and in Part 2 (MAD), there will be 3 cohorts. In Part 1, a single dose of HC002 or placebo will be administered on Day 1. In Part 2, multiple doses of HC002 or placebo will be administered once daily (QD) from Day 1 to Day 7.
- Conditions
- Inflammatory Disease, Autoimmune Diseases
- Being tested
- HC002 SAD, HC002 MAD, Placebo
- Medical subject headings
- Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HC002 SADDrug
Part 1 will enroll 32 participants across 4 cohorts.
Route of administration: Oral Dose interval and frequency: Single oral dose range across 4 cohorts.
HC002 MADDrug
Part 2 will enroll 24 participants across 3 cohorts.
Route of administration: Oral Dose interval and frequency: Once daily for 7 days
PlaceboDrug
Matching placebo will be administered across SAD and MAD
| Study group | Role | What they receive |
|---|---|---|
| Part 1 SAD | Experimental | Not described Receives: Drug: HC002 SAD |
| Part 2 MAD | Experimental | Not described Receives: Drug: HC002 MAD |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety of HC002 by the incidence of adverse events
Measured: SAD- Screening to Day 4 post first dose administration; MAD- screening to Day 11 post first dose administration
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
Measured: SAD- Screening to Day 4 post first dose administration; MAD- screening to Day 11 post first dose administration
Number of participants with changes to the electrocardiogram (ECG) from baseline recorded as adverse events
Measured: SAD- Screening to Day 4 post first dose administration; MAD- screening to Day 11 post first dose administration
Secondary outcomes (9)
Plasma PK parameters- Maximum plasma concentration (Cmax) after first dose of HC002
Measured: 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
Plasma PK parameters- Time for maximum plasma concentration (Tmax) after first dose of HC002
Measured: 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
Plasma PK parameters-- Area under curve (AUC) after first dose of HC002
Measured: 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
Plasma PK parameters- Apparent clearance (CL/F) after first dose of HC002
Measured: 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
Plasma PK parameters- terminal half-life (t1/2) after first dose of HC002
Measured: 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
Plasma PK parameters- Vz/F (apparent volume of distribution) after first dose of HC002
Measured: 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
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
Measured: 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]
Urine PK parameters- fet1-t2 (fraction of analyte excreted in urine from time point t1 to t2) after first dose of HC002
Measured: 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
Urine PK parameters-Clearance rate (CLr) after first dose of HC002
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start21 Nov 2024
- Primary completion31 Mar 2025
- Study completion7 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Holoclara Aus Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06670274
- Sponsor's protocol ID
- HC002-001-24
- Status last verified
- May 2025
- First submitted
- 21 Oct 2024
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06670274
- Acronym / sponsor ID
- HC002-001-24
- Conditions
- Inflammatory Disease, Autoimmune Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Holoclara Aus Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 21 Nov 2024 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 7 May 2025 (actual)
- First posted
- 1 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a first-in-human (FIH) study to evaluate the safety, tolerability, and pharmacokinetics (PK) of single and multiple ascending oral doses of HC002 in healthy adult participants.
Detailed description
This is a single center, randomized, double-blind, placebo-controlled, two-part study to evaluate the safety, tolerability, and PK of single (Part 1) and multiple (Part 2) oral doses of HC002.
The study will enroll approximately 56 participants across 2 parts. In Part 1 (SAD), there will be 4 cohorts and in Part 2 (MAD), there will be 3 cohorts. In Part 1, a single dose of HC002 or placebo will be administered on Day 1. In Part 2, multiple doses of HC002 or placebo will be administered once daily (QD) from Day 1 to Day 7.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1 SAD | Experimental | Drug: HC002 SAD |
| Part 2 MAD | Experimental | Drug: HC002 MAD |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male and female participants of 18 to 65 years of age (inclusive)
- Able to read, understand, sign, and date a written informed consent form (ICF) before study participation at Screening
- Male participants must agree to use accepted contraceptive regimens during the study and for a period after the last drug administration.
- 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.
- Body mass index (BMI) between 18.0 and 35.0 kg/m2 (inclusive) at screening and body weight ≥ 50 kg.
Key exclusion criteria (15 listed)
- 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.
- Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with PK of the study drug (except appendectomy, hemorrhoidectomy and simple hernia repair).
- 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.
- Consumption of herbal medications, dietary supplements, and specific fruit products (ie, pomello, Seville orange, and grapefruit).
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HC002 SADPart 1 will enroll 32 participants across 4 cohorts. Route of administration: Oral Dose interval and frequency: Single oral dose range across 4 cohorts. | Drug | Part 1 SAD |
| HC002 MADPart 2 will enroll 24 participants across 3 cohorts. Route of administration: Oral Dose interval and frequency: Once daily for 7 days | Drug | Part 2 MAD |
| PlaceboMatching placebo will be administered across SAD and MAD | Drug | Placebo |
Primary outcome
To assess the safety of HC002 by the incidence of adverse events
Time frame: SAD- Screening to Day 4 post first dose administration; MAD- screening to Day 11 post first dose administration
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
Time frame: SAD- Screening to Day 4 post first dose administration; MAD- screening to Day 11 post first dose administration
Number of participants with changes to the electrocardiogram (ECG) from baseline recorded as adverse events
Time frame: SAD- Screening to Day 4 post first dose administration; MAD- screening to Day 11 post first dose administration
9 secondary outcomes
Plasma PK parameters- Maximum plasma concentration (Cmax) after first dose of HC002
Time frame: 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
Plasma PK parameters- Time for maximum plasma concentration (Tmax) after first dose of HC002
Time frame: 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
Plasma PK parameters-- Area under curve (AUC) after first dose of HC002
Time frame: 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
Plasma PK parameters- Apparent clearance (CL/F) after first dose of HC002
Time frame: 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
Plasma PK parameters- terminal half-life (t1/2) after first dose of HC002
Time frame: 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
Plasma PK parameters- Vz/F (apparent volume of distribution) after first dose of HC002
Time frame: 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
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
Time frame: 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]
Urine PK parameters- fet1-t2 (fraction of analyte excreted in urine from time point t1 to t2) after first dose of HC002
Time frame: 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
Urine PK parameters-Clearance rate (CLr) after first dose of HC002
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HC002 SAD and HC002 MAD in people with Inflammatory Disease and Autoimmune Diseases, run by Holoclara Aus Pty Ltd at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the safety of HC002 by the incidence of adverse events (time frame: SAD- Screening to Day 4 post first dose administration; MAD- screening to Day 11 post first dose administration). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.