Status:
COMPLETED
Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers
Lead Sponsor:
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This is a Phase 1 randomized, double blinded, placebo-controlled, single dose escalation study to evaluate the safety, tolerability, and PK of 611 in healthy volunteers.
Detailed Description
Total duration of the study period per subject is about 4 months broken down as follows: The screening period is up to 28 days, one dose treatment, and follow- up period is up to 71±7 days (90±9 days...
Eligibility Criteria
Inclusion
- Able to understand and willing to sign the ICF
- Healthy male and female subjects, non-smokers, 18-55 years of age
- In the opinion of the investigator, with no significant medical history, and in good health.
- Body mass index 19.0-32.0 kg/m2 and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females.
- Subjects are able to follow the study protocol and complete the trial.
Exclusion
- History of hypersensitivity to similar drugs to 611 or their excipients.
- Pregnant, or nursing females.
- HepBsAg or HepCAb positive.
- Human immunodeficiency virus (HIV) positive.
- Positive urine drug screen, or cotinine test.
- Any reason which, in the opinion of the Qualified Investigator, would prevent the subject from participating in the study.
Key Trial Info
Start Date :
September 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 13 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04527718
Start Date
September 9 2020
End Date
August 13 2021
Last Update
November 10 2022
Active Locations (1)
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1
Covance Dallas Clinical Research Unit
Dallas, Texas, United States, 75247