Status:
COMPLETED
A Phase I Randomized, Double-Blind, Placebo-Controlled, Parallel Group Clinical Study of ICP-332 in Healthy Subjects
Lead Sponsor:
Beijing InnoCare Pharma Tech Co., Ltd.
Conditions:
Healthy Subjects
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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.
- Age and fertility status
- Male or infertile female subjects who are between 18-45 years old (inclusive).
- Female subjects who are infertile.
- Male subjects and their partners must agree to use effective contraception.
Exclusion
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic and other diseases, or allergic diseases.
- Subjects with clinically significant gastrointestinal dysfunction that may affect drug intake, transport or absorption.
- Acute disease state (such as nausea, vomiting, pyrexia or diarrhea, etc.) within 14 days before administration.
- Other situations judged by the investigator to be unsuitable to join this trial.
Key Trial Info
Start Date :
August 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 18 2022
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT05399030
Start Date
August 14 2021
End Date
February 18 2022
Last Update
August 8 2022
Active Locations (1)
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1
Jinan Central Hospital
Jinan, China, 250013