A Trial of SHR2285 in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: SHR2285

• Registration Number: NCT04829305
• 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 SHR2285 in healthy subjects

Study Timeline

• Study First Submitted: 2021-03-30
• Study First Submitted QC: 2021-04-01
• Study First Posted: 2021-04-02
• Study Start: 2021-05-20
• Primary Completion: 2021-09-06
• Study Completion: 2021-09-06
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-21
• Last Update Posted: 2022-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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).
• Receipt of any other investigational drugs or medical devices within 3 months prior to screening (from the date of signed consent form).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Low dose of SHR2285	SHR2285	The subjects will receive a single dose of SHR2285 (cohort 1).
High dose of SHR2285	SHR2285	The subjects will receive a single dose of SHR2285 (cohort 3).
Medium dose of SHR2285	SHR2285	The subjects will receive a single dose of SHR2285 (cohort 2).

Primary Outcome Measures

Name	Time	Method
Adverse events	Start of Treatment to end of study (approximately 7 days)	Incidence and severity of adverse events

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics-AUC0-last	Start of Treatment to outpatient (approximately 3 days)	Area under the concentration-time curve from time 0 to last time point after SHR2285 administration
Pharmacokinetics-AUC0-inf	Start of Treatment to outpatient (approximately 3 days)	Area under the concentration-time curve from time 0 to infinity after SHR2285 administration
Pharmacokinetics-Tmax	Up to 3 days	Time to Cmax of SHR2285 and its metabolite SHR164471
Pharmacokinetics-Cmax	Up to 3 days	Maximum observed concentration of SHR2285 and its metabolite SHR164471
Pharmacokinetics-CL/F	Up to 3 days	Apparent clearance of SHR2285 and its metabolite SHR164471
Pharmacokinetics-Vz/F	Up to 3 days	Apparent volume of distribution during terminal phase of SHR2285 and its metabolite SHR164471
Coagulation factor XI (FXI) activity	Up to 3 days	Coagulation factor XI (FXI) activity
Activated partial thromboplastin time	Up to 3 days	Activated partial thromboplastin time
Pharmacokinetics-t1/2	Up to 3 days	Terminal elimination half-life of SHR2285 and its metabolite SHR164471
Percentage change of coagulation factor XI (FXI) activity thromboplastin time (APTT) and fold change from baseline	Up to 3 days	Percentage change of coagulation factor XI (FXI) activity
Prothrombin time	Up to 3 days	Prothrombin time
Fold change of activated partial thromboplastin time from baseline	Up to 3 days	Fold change of activated partial thromboplastin time from baseline
Fold change of prothrombin time from baseline	Up to 3 days	Fold change of prothrombin time from baseline
International normalized ratio	Up to 3 days	International normalized ratio
Fold change of international normalized ratio from baseline	Up to 3 days	Fold change of international normalized ratio from baseline

Trial Locations

Locations (1)

Linear Clinical research; 🇦🇺 Perth, Western Australia, Australia