Status:
TERMINATED
A Trial of SHR-1703 in Healthy Subjects
Lead Sponsor:
Atridia Pty Ltd.
Conditions:
Asthma
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This is a randomized, double-blind, placebo-controlled, single dose escalation phase 1 study. The objective of this study is to evaluate the safety, tolerability, pharmacokinetics pharmacodynamics and...
Detailed Description
The study will consist of one dose esclation part with a total of 3 dose levels. The Subjects will be randomized to receive SHR-1703 as reflected by the guiding principle for the dose esclation/expans...
Eligibility Criteria
Inclusion
- Healthy Caucasian subjects, male and female, 18 to 55 years of age, inclusive;
- Body weight ≥45 kg (Both male and female), body mass index (BMI) between ≥19.0 and ≤29.9 kg/m2, inclusive;
- No clinically significant abnormalities in medical history, general physical examination, vital signs, laboratory tests (hematology, urinalysis, blood chemistry and coagulation function) and ECG at the investigator's discretion during screening and baseline.
- 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 30-days after last scheduled follow-up visit.
Exclusion
- Known history or suspected of being allergic to the study drug.
- Positive hepatitis B virus (HBsAg), hepatitis C virus (HCV-Ab), human immunodeficiency virus (HIV-Ab) at screening.
- Participation in clinical trials of other investigational drugs or medical devices within 3 months prior to screening or within 5 half-lives of any drugs during screening visit, or in the follow-up period of a clinical study whichever is longer
- Use of any medicine within 4-weeks prior to the IP administration
- Blood donation or loss of more than 400 mL of blood within 1 month of screening; or received blood transfusion within 2 months before screening.
- Live (attenuated) vaccination within 1 month before screening or plan to be vaccinated
- Severe injuries or major surgeries within 6 months before screening or plan to do surgeries during the trial
- Patients with known or suspected parasitic infection within 6 months before screening
- Either ALT, AST, ALP, GGT or total bilirubin level exceeds upper limit of normal range (ULN) at screening or baseline visits (confirmed by a single repeat, as per investigator's judgment)
- More than 5 cigarettes daily (or products with equivalent amount of nicotine) for 3 months prior to screening.
- History of alcohol abuse within 3 months prior to the IP administration
Key Trial Info
Start Date :
June 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 18 2021
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT04855591
Start Date
June 14 2021
End Date
November 18 2021
Last Update
December 1 2021
Active Locations (1)
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1
Nucleus Network
Brisbane, Queensland, Australia