A Trial of SHR8735 in Healthy Subjects
- Registration Number
- NCT04701216
- Lead Sponsor
- Atridia Pty Ltd.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
Inclusion Criteria
- 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 Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental: SHR8735 cohort 1 SHR8735 The subjects will receive a multiple dose of SHR8735 (low dose). Experimental: SHR8735 cohort 3 SHR8735 The subjects will receive a single dose of SHR8735 (high dose). Experimental: SHR8735 cohort 2 SHR8735 The subjects will receive a single dose of SHR8735 (medium dose).
- Primary Outcome Measures
Name Time Method Adverse events Start of Treatment to end of study (approximately 28 days) Incidence and severity of adverse events
- Secondary Outcome Measures
Name Time Method Pharmacokinetics-t1/2 Up to 15 days Terminal elimination half-life of SHR8735
Pharmacokinetics-AUC0-last Start of Treatment to end of study (approximately 15 days) Area under the concentration-time curve from time 0 to last time point after SHR8735 administration
Pharmacokinetics-AUC0-inf Start of Treatment to end of study (approximately 15 days) Area under the concentration-time curve from time 0 to infinity after SHR8735 administration
Pharmacokinetics-Tmax Up to 15 days Time to Cmax of SHR8735
Pharmacokinetics-Cmax Up to 15 days Maximum observed concentration of SHR8735
Pharmacokinetics-CL/F Up to 15 days Apparent clearance of SHR8735
Pharmacokinetics-Vz/F Up to 15 days Apparent volume of distribution during terminal phase of SHR8735
Change from baseline to end of treatment for platelet count Up to 28 days
Trial Locations
- Locations (1)
Linear Clinical research
🇦🇺Perth, Western Australia, Australia