Healthy Subjects
Conditions
Brief summary
A multiple ascending dose phase I study of ICP-332 in healthy subjects
Interventions
DRUGICP-332 Tablets
Eligible patients will receive ICP-332 tablets orally as per the protocol
Eligible patients will receive ICP-332 placebo tablets orally as per the protocol
Sponsors
InnoCare Pharma Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with Adverse Events (AEs) | Up to Day 28 |
| Number of Participants With Clinically Significant Change in Vital Signs | Up to Day 28 |
| Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) | Up to Day 28 |
| Number of Participants With Clinically Significant Change in Physical Examination | Up to Day 28 |
| Number of Participants With Clinically Significant Change in Clinical Laboratory Values | Up to Day 28 |
Countries
United States
Outcome results
None listed