A Trial of SHR8735 in Healthy Subjects

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04701216
• Other study ID #: SHR8735-I-113
• Status: Completed
• Phase: Phase 1
• Start date: February 11, 2021
• Est. completion date: July 15, 2021

Study information

• Verified date: November 2021
• Source: Atridia Pty Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a phase 1 open-label study.

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 information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: July 15, 2021
• Est. primary completion date: July 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• SHR8735
SHR8735 is an thrombopoietin receptor agonist to promote platelet production.

Locations

Country	Name	City	State
Australia	Linear Clinical research	Perth	Western Australia

Sponsors (1)

Lead Sponsor	Collaborator
Atridia Pty Ltd.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events	Incidence and severity of adverse events	Start of Treatment to end of study (approximately 28 days)
Secondary	Pharmacokinetics-AUC0-last	Area under the concentration-time curve from time 0 to last time point after SHR8735 administration	Start of Treatment to end of study (approximately 15 days)
Secondary	Pharmacokinetics-AUC0-inf	Area under the concentration-time curve from time 0 to infinity after SHR8735 administration	Start of Treatment to end of study (approximately 15 days)
Secondary	Pharmacokinetics-Tmax	Time to Cmax of SHR8735	Up to 15 days
Secondary	Pharmacokinetics-Cmax	Maximum observed concentration of SHR8735	Up to 15 days
Secondary	Pharmacokinetics-CL/F	Apparent clearance of SHR8735	Up to 15 days
Secondary	Pharmacokinetics-Vz/F	Apparent volume of distribution during terminal phase of SHR8735	Up to 15 days
Secondary	Pharmacokinetics-t1/2	Terminal elimination half-life of SHR8735	Up to 15 days
Secondary	Change from baseline to end of treatment for platelet count		Up to 28 days