A Trial of SHR8735 in Healthy Subjects

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

This is a phase 1 open-label study.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: SHR8735

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

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Western Australia
    • Perth, Western Australia, Australia, 6009
      • Linear Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 51 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: SHR8735 cohort 1; The subjects will receive a multiple dose of SHR8735 (low dose).	Drug: SHR8735; SHR8735 is an thrombopoietin receptor agonist to promote platelet production.
Experimental: Experimental: SHR8735 cohort 2; The subjects will receive a single dose of SHR8735 (medium dose).	Drug: SHR8735; SHR8735 is an thrombopoietin receptor agonist to promote platelet production.
Experimental: Experimental: SHR8735 cohort 3; The subjects will receive a single dose of SHR8735 (high dose).	Drug: SHR8735; SHR8735 is an thrombopoietin receptor agonist to promote platelet production.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Incidence and severity of adverse events	Start of Treatment to end of study (approximately 28 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
Pharmacokinetics-Tmax	Time to Cmax of SHR8735	Up to 15 days
Pharmacokinetics-Cmax	Maximum observed concentration of SHR8735	Up to 15 days
Pharmacokinetics-CL/F	Apparent clearance of SHR8735	Up to 15 days
Pharmacokinetics-Vz/F	Apparent volume of distribution during terminal phase of SHR8735	Up to 15 days
Pharmacokinetics-t1/2	Terminal elimination half-life of SHR8735	Up to 15 days
Change from baseline to end of treatment for platelet count		Up to 28 days

Collaborators and Investigators

• Sponsor: Atridia Pty Ltd.
• Investigators: Principal Investigator: Ana Sun, Dr, Study Principal Investigator

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2021
• Primary Completion (Actual): July 15, 2021
• Study Completion (Actual): July 15, 2021

Study Registration Dates

• First Submitted: January 6, 2021
• First Submitted That Met QC Criteria: January 6, 2021
• First Posted (Actual): January 8, 2021

Study Record Updates

• Last Update Posted (Actual): November 9, 2021
• Last Update Submitted That Met QC Criteria: November 7, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: SHR8735-I-113

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No