Testing ICP-332 in healthy volunteers
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
This study is testing a new drug called ICP-332 in healthy volunteers to see how safe it is and how it affects the body.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | InnoCare Pharma Inc. Industry-sponsored |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT06530966 on ClinicalTrials.gov |
What this trial studies
This is a Phase I clinical trial designed to evaluate the safety and tolerability of multiple ascending doses of ICP-332 in healthy subjects. Participants will receive either ICP-332 tablets or placebo tablets to assess the drug's effects. The study aims to gather data on how the drug behaves in the body and its potential side effects. Healthy male and infertile female volunteers aged 18 to 55 with a BMI between 18.5 and 30 kg/m2 are eligible to participate.
Who should consider this trial
Good fit: Ideal candidates are healthy male or infertile female individuals aged 18-55 with a BMI between 18.5 and 30 kg/m2.
Not a fit: Patients with significant current or past diseases, allergies, or clinically significant abnormalities will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide important safety data that may lead to future treatments for various conditions.
How similar studies have performed: While this approach is common in early-phase trials, the specific drug ICP-332 has not been previously tested in this manner.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Voluntarily sign the informed consent form 2. Body mass index (BMI) of ≥ 18.5 kg/m2 and \< 30 kg/m2 3. Male or infertile female subjects who are between 18-55 years old (inclusive) Exclusion Criteria: 1. Significant current or past acute or chronic disease or condition. 2. A history of tuberculosis or current active/latent infection. 3. With a history of drug or food allergy, or allergy to any of the composition components of the study drug, or allergic disease. 4. Subjects with clinically significant abnormalities in the screening examinations.
Where this trial is running
Baltimore, Maryland
- Pharmaron CPC Inc. — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Study coordinator: Alexia Lu
- Email: CO_HGRAC@innocarepharma.com
- Phone: 010-66609745
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.