Status:
COMPLETED
A Trial of SHR8735 in Healthy Subjects
Lead Sponsor:
Atridia Pty Ltd.
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This is a phase 1 open-label study.
Detailed Description
This is a phase 1 open-label study. The objective of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of oral administered SHR8735 in healthy subjects
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
- Receipt of any other investigational drugs or medical devices within 3 months prior to screening (according to the date of signed consent form).
- History of illicit or prescription drug abuse or addiction within one year of screening, or positive urine drug screen at screening and Day-1. The urine drug screen may be repeated at the discretion of the investigator and the reason for repeat needs to be documented clearly (e.g., suspicion of false positive due to diet).
- Severe, active psychiatric conditions that require ongoing treatment.
Key Trial Info
Start Date :
February 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 15 2021
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04701216
Start Date
February 11 2021
End Date
July 15 2021
Last Update
November 9 2021
Active Locations (1)
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1
Linear Clinical research
Perth, Western Australia, Australia, 6009