A Trial of SHR2285 in Healthy Subjects

A Phase 1, Single Center, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR2285 Single Oral Administration in Healthy Caucasian Participants

This is a phase 1 open-label study

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: SHR2285

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 Type: Interventional
• Enrollment (Actual): 31
• 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: 18 years to 55 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).
• Receipt of any other investigational drugs or medical devices within 3 months prior to screening (from the date of signed consent form).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low dose of SHR2285; The subjects will receive a single dose of SHR2285 (cohort 1).	Drug: SHR2285; SHR2285 is a selective inhibition of human FXIa small molecule compound.
Experimental: Medium dose of SHR2285; The subjects will receive a single dose of SHR2285 (cohort 2).	Drug: SHR2285; SHR2285 is a selective inhibition of human FXIa small molecule compound.
Experimental: High dose of SHR2285; The subjects will receive a single dose of SHR2285 (cohort 3).	Drug: SHR2285; SHR2285 is a selective inhibition of human FXIa small molecule compound.

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

Collaborators and Investigators

• Sponsor: Atridia Pty Ltd.
• Investigators: Principal Investigator: Dr Jasmine Daisy Williams, Study Principal Investigator

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2021
• Primary Completion (Actual): September 6, 2021
• Study Completion (Actual): September 6, 2021

Study Registration Dates

• First Submitted: March 30, 2021
• First Submitted That Met QC Criteria: April 1, 2021
• First Posted (Actual): April 2, 2021

Study Record Updates

• Last Update Posted (Actual): March 8, 2022
• Last Update Submitted That Met QC Criteria: February 21, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: SHR2285-105

Drug and device information, study documents

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