Status:
COMPLETED
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Dose Escalation Study in Healthy Subjects
Lead Sponsor:
Shanghai Hengrui Pharmaceutical Co., Ltd.
Conditions:
Asthma
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This is a single center, randomized, double-blind, placebo-controlled, single and multiple dose escalation phase 1 study. The objective of this study is to evaluate the safety, tolerability, pharmacok...
Eligibility Criteria
Inclusion
- Ability to understand the trial procedures and possible adverse events, volunteers to participate in the trial, and provides written informed consent.
- Be able to comply with all the requirements and able to complete the study.
- Male or female aged between 18 years and 55 years (inclusive) at the date of signed consent form.
- No clinically significant abnormalities in medical history, general physical examination, vital signs, and laboratory tests.
- Men and women of childbearing potential (WOCBP) must agree to take effective contraceptive methods and have no plan to have a child from signing the consent form to 16 weeks after IP administration.
Exclusion
- Positive hepatitis B virus (HBsAg), hepatitis C virus (HCV-Ab), human immunodeficiency virus (HIV-Ab), or QuantiFERON-TB Gold tests at screening;
- Participation in clinical trials of other investigational drugs or medical devices within 3 months prior to screening (according to the date of signed consent form), or in the follow-up period of a clinical study
- Severe injuries or surgeries within 6 months before screening or plan to do surgeries during the trial
- Any other circumstances that, in the investigator's judgment, may increase the risk associated with the subject's participation in and completion of the study or could preclude the evaluation of the subject's response
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 10 2021
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT04772365
Start Date
March 1 2021
End Date
December 10 2021
Last Update
November 29 2022
Active Locations (1)
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1
The Third Xiangya Hospital of Central South University
Changsha, Changsha, China, 410013