Status:
COMPLETED
A Trial of SHR-1905 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 and immunogenicity o...
Detailed Description
The study will consist of one dose esclation part with a total of 5 dose levels. The Subjects will be randomized to receive SHR-1905 as reflected by the guiding principle for the dose esclation/expans...
Eligibility Criteria
Inclusion
- Ability to understand the trial procedures and possible adverse events, volunteers to participate in the trial.
- Male or female aged between 18 years and 55 years (inclusive) at the date of signed consent form.
- Total body weight ≥45 kg at screening, and body mass index (BMI) between 18 and 28 kg/m2 (inclusive).
- For healthy subjects, no clinically significant abnormalities.
- Men and women of childbearing potential (WOCBP) must agree to take effective contraceptive methods
Exclusion
- Known medical history of severe disease in cardiovascular, liver, kidney, digestive tract, mental nerve, hematology, metabolic disorders, etc.
- Severe injuries or major surgeries within 6 months before screening.
- Subjects with infecious disease.
- Hyper/Hypotension at screening and at check in.
- Clinically significant abnormalities in 12-Lead ECG
- More than 5 cigarettes daily (or products with equivalent amount of nicotine) for 3 months prior to screening
- Positive urine drug screen .
- Subject who cannot perform venous blood sampling.
- Known history or suspected of being allergic to the study drugs and their excipients.
- Use of any medicine within 4-weeks or within 5 half-lives
- History of alcohol abuse within 3 months prior to the IP administration .
- Participation in clinical trials of other investigational drugs or medical devices within 3 months prior to screening
- in the investigator's judgment, may increase the risk to the subject
Key Trial Info
Start Date :
July 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 12 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04800263
Start Date
July 27 2021
End Date
November 12 2022
Last Update
May 10 2023
Active Locations (1)
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1
Nucleus Network
Brisbane, Queensland, Australia