Healthy SubjectsPhase 1NCT06530966
Phase I Study of ICP-332 in Healthy Subjects
A Phase 1 study testing ICP-332 Tablets in people with Healthy Subjects, run by InnoCare Pharma Inc. at 1 site in United States.
Trial summary
A multiple ascending dose phase I study of ICP-332 in healthy subjects Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- ICP-332 Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2024to 8 Nov 2024
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Voluntarily sign the informed consent form
- Body mass index (BMI) of ≥ 18.5 kg/m2 and < 30 kg/m2
- Male or infertile female subjects who are between 18-55 years old (inclusive)
Who cannot join
- Significant current or past acute or chronic disease or condition.
- A history of tuberculosis or current active/latent infection.
- With a history of drug or food allergy, or allergy to any of the composition components of the study drug, or allergic disease.
- Subjects with clinically significant abnormalities in the screening examinations.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ICP-332 in Healthy Subjects
A multiple ascending dose phase I study of ICP-332 in healthy subjects
- Conditions
- Healthy Subjects
- Being tested
- ICP-332 Tablets, ICP-332 Placebo Tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICP-332 TabletsDrug
Eligible patients will receive ICP-332 tablets orally as per the protocol
ICP-332 Placebo TabletsDrug
Eligible patients will receive ICP-332 placebo tablets orally as per the protocol
| Study group | Role | What they receive |
|---|---|---|
| ICP-332 | Experimental | Not described Receives: Drug: ICP-332 Tablets |
| Placebo | Placebo comparator | Not described Receives: Drug: ICP-332 Placebo Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Adverse Events (AEs)
Measured: Up to Day 28
Number of Participants With Clinically Significant Change in Vital Signs
Measured: Up to Day 28
Number of Participants With Clinically Significant Change in Electrocardiogram (ECG)
Measured: Up to Day 28
Number of Participants With Clinically Significant Change in Physical Examination
Measured: Up to Day 28
Number of Participants With Clinically Significant Change in Clinical Laboratory Values
Measured: Up to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start23 Jul 2024
- Primary completion8 Nov 2024
- Study completion8 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- InnoCare Pharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06530966
- Sponsor's protocol ID
- ICP-CL-00605
- Status last verified
- Apr 2026
- First submitted
- 28 Jul 2024
- Last updated
- 14 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ICP-332 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06530966
- Acronym / sponsor ID
- ICP-CL-00605
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- InnoCare Pharma Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Jul 2024 (actual)
- Primary completion
- 8 Nov 2024 (actual)
- Study completion
- 8 Nov 2024 (actual)
- First posted
- 31 Jul 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.
A multiple ascending dose phase I study of ICP-332 in healthy subjects
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICP-332 | Experimental | Drug: ICP-332 Tablets |
| Placebo | Placebo comparator | Drug: ICP-332 Placebo Tablets |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Voluntarily sign the informed consent form
- Body mass index (BMI) of ≥ 18.5 kg/m2 and < 30 kg/m2
- Male or infertile female subjects who are between 18-55 years old (inclusive)
Key exclusion criteria (4 listed)
- Significant current or past acute or chronic disease or condition.
- A history of tuberculosis or current active/latent infection.
- With a history of drug or food allergy, or allergy to any of the composition components of the study drug, or allergic disease.
- Subjects with clinically significant abnormalities in the screening examinations.
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 |
|---|---|---|
| ICP-332 TabletsEligible patients will receive ICP-332 tablets orally as per the protocol | Drug | ICP-332 |
| ICP-332 Placebo TabletsEligible patients will receive ICP-332 placebo tablets orally as per the protocol | Drug | Placebo |
Primary outcome
Number of participants with Adverse Events (AEs)
Time frame: Up to Day 28
Number of Participants With Clinically Significant Change in Vital Signs
Time frame: Up to Day 28
Number of Participants With Clinically Significant Change in Electrocardiogram (ECG)
Time frame: Up to Day 28
Number of Participants With Clinically Significant Change in Physical Examination
Time frame: Up to Day 28
Number of Participants With Clinically Significant Change in Clinical Laboratory Values
Time frame: Up to Day 28
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 14 Apr 2026.
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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 ICP-332 Tablets in people with Healthy Subjects, run by InnoCare Pharma Inc. at 1 site in United States.
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 3 inclusion and 4 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 14 Apr 2026. 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 United States. 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?
Number of participants with Adverse Events (AEs) (time frame: Up to Day 28). The study lists 5 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 14 Apr 2026.