A Phase 1 Open-Label Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of SHR8735 in Healthy Chinese and Caucasian Subjects

Atridia Pty Ltd.1 site in 1 country48 target enrollmentFebruary 11, 2021

ConditionsHealthy Volunteers

InterventionsSHR8735

DrugsSHR8735

Overview

Phase: Phase 1
Intervention: SHR8735
Conditions: Healthy Volunteers
Sponsor: Atridia Pty Ltd.
Enrollment: 48
Locations: 1
Primary Endpoint: Adverse events
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

February 11, 2021

End Date

July 15, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Atridia Pty Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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-
•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.

Arms & Interventions

Experimental: SHR8735 cohort 1

The subjects will receive a multiple dose of SHR8735 (low dose).

Intervention: SHR8735

Experimental: SHR8735 cohort 2

The subjects will receive a single dose of SHR8735 (medium dose).

Intervention: SHR8735

Experimental: SHR8735 cohort 3

The subjects will receive a single dose of SHR8735 (high dose).

Intervention: SHR8735

Outcomes

Primary Outcomes

Adverse events

Time Frame: Start of Treatment to end of study (approximately 28 days)

Incidence and severity of adverse events

Secondary Outcomes

Pharmacokinetics-AUC0-last(Start of Treatment to end of study (approximately 15 days))
Pharmacokinetics-AUC0-inf(Start of Treatment to end of study (approximately 15 days))
Pharmacokinetics-Tmax(Up to 15 days)
Pharmacokinetics-Cmax(Up to 15 days)
Pharmacokinetics-CL/F(Up to 15 days)
Pharmacokinetics-Vz/F(Up to 15 days)
Change from baseline to end of treatment for platelet count(Up to 28 days)
Pharmacokinetics-t1/2(Up to 15 days)