A Trial of SHR8735 in Healthy Subjects

• ClinicalTrials.gov Identifier: NCT04701216
• Recruitment Status: Completed
• First Posted: January 8, 2021
• Last Update Posted: November 9, 2021
• Sponsor: Atridia Pty Ltd.
• Information provided by (Responsible Party): Atridia Pty Ltd.

Study Description

Brief Summary:

This is a phase 1 open-label study.

Condition or disease	Intervention/treatment	Phase
Healthy Volunteers	Drug: SHR8735	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 48 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 1 Open-Label Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of SHR8735 in Healthy Chinese and Caucasian Subjects
• Actual Study Start Date: February 11, 2021
• Actual Primary Completion Date: July 15, 2021
• Actual Study Completion Date: July 15, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Adverse events [ Time Frame: Start of Treatment to end of study (approximately 28 days) ]
   Incidence and severity of adverse events

Secondary Outcome Measures :

1. Pharmacokinetics-AUC0-last [ Time Frame: 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
2. Pharmacokinetics-AUC0-inf [ Time Frame: Start of Treatment to end of study (approximately 15 days) ]
   Area under the concentration-time curve from time 0 to infinity after SHR8735 administration
3. Pharmacokinetics-Tmax [ Time Frame: Up to 15 days ]
   Time to Cmax of SHR8735
4. Pharmacokinetics-Cmax [ Time Frame: Up to 15 days ]
   Maximum observed concentration of SHR8735
5. Pharmacokinetics-CL/F [ Time Frame: Up to 15 days ]
   Apparent clearance of SHR8735
6. Pharmacokinetics-Vz/F [ Time Frame: Up to 15 days ]
   Apparent volume of distribution during terminal phase of SHR8735
7. Pharmacokinetics-t1/2 [ Time Frame: Up to 15 days ]
   Terminal elimination half-life of SHR8735
8. Change from baseline to end of treatment for platelet count [ Time Frame: Up to 28 days ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 55 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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-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.

Contacts and Locations

Locations

Australia, Western Australia

Linear Clinical research

Perth, Western Australia, Australia, 6009

Sponsors and Collaborators

Atridia Pty Ltd.

Investigators

• Principal Investigator: Ana Sun, Dr; Study Principal Investigator

More Information

• Responsible Party: Atridia Pty Ltd.
• ClinicalTrials.gov Identifier: NCT04701216
• Other Study ID Numbers: SHR8735-I-113
• First Posted: January 8, 2021
• Last Update Posted: November 9, 2021
• Last Verified: November 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No