A Phase I Randomized, Double-Blind, Placebo-Controlled, Parallel Group Clinical Study of ICP-332 in Healthy Subjects

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Single and Multiple Ascending Dose Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ICP-332 in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05399030

Enrollment

Registered

2022-06-01

Start date

2021-08-14

Completion date

2022-02-18

Last updated

2022-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subjects

Brief summary

This is a randomized, double-blind, placebo-controlled, parallel group, single and multiple ascending dose phase I study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ICP-332 in Healthy Subjects

Interventions

DRUGICP-332

ICP-332 will be administered as tablet

OTHERPlacebo

Matching placebo will be administered as tablet

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

OTHER

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

1. Body mass index (BMI) between 18-26 kg/m2, the weight of male subject should not be less than 50 kg, and the weight of female subject should not be less than 45 kg. 2. Age and fertility status 1. Male or infertile female subjects who are between 18-45 years old (inclusive). 2. Female subjects who are infertile. 3. Male subjects and their partners must agree to use effective contraception.

Exclusion criteria

1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic and other diseases, or allergic diseases. 2. Subjects with clinically significant gastrointestinal dysfunction that may affect drug intake, transport or absorption. 3. Acute disease state (such as nausea, vomiting, pyrexia or diarrhea, etc.) within 14 days before administration. 4. Other situations judged by the investigator to be unsuitable to join this trial.

Design outcomes

Primary

Measure	Time frame
Number of participants with Treatment-Emergent Adverse Events (AEs).	Baseline up to 28 days after last dose.

Secondary

Measure	Time frame	Description
Change from baseline in Maximum concentration (Cmax)	Single ascending dose: baseline up to 72 hours; post-dose multiple ascending dose: baseline to Day 14.	—
Change from baseline in blood cells.	Multiple ascending dose: Baseline to 28 days.	measuraments (e.g. blood biochemistry tests, hematology, coagulation tests); outcome measure (e.g. absolute blood cells count)

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026