A Trial of SHR2285 in Healthy Subjects

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04829305
• Other study ID #: SHR2285-105
• Status: Completed
• Phase: Phase 1
• Start date: May 20, 2021
• Est. completion date: September 6, 2021

Study information

• Verified date: February 2022
• 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 SHR2285 in healthy subjects

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: September 6, 2021
• Est. primary completion date: September 6, 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).

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• SHR2285
SHR2285 is a selective inhibition of human FXIa small molecule compound.

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 7 days)
Secondary	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)
Secondary	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)
Secondary	Pharmacokinetics-Tmax	Time to Cmax of SHR2285 and its metabolite SHR164471	Up to 3 days
Secondary	Pharmacokinetics-Cmax	Maximum observed concentration of SHR2285 and its metabolite SHR164471	Up to 3 days
Secondary	Pharmacokinetics-CL/F	Apparent clearance of SHR2285 and its metabolite SHR164471	Up to 3 days
Secondary	Pharmacokinetics-Vz/F	Apparent volume of distribution during terminal phase of SHR2285 and its metabolite SHR164471	Up to 3 days
Secondary	Pharmacokinetics-t1/2	Terminal elimination half-life of SHR2285 and its metabolite SHR164471	Up to 3 days
Secondary	Coagulation factor XI (FXI) activity	Coagulation factor XI (FXI) activity	Up to 3 days
Secondary	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
Secondary	Activated partial thromboplastin time	Activated partial thromboplastin time	Up to 3 days
Secondary	Fold change of activated partial thromboplastin time from baseline	Fold change of activated partial thromboplastin time from baseline	Up to 3 days
Secondary	Prothrombin time	Prothrombin time	Up to 3 days
Secondary	Fold change of prothrombin time from baseline	Fold change of prothrombin time from baseline	Up to 3 days
Secondary	International normalized ratio	International normalized ratio	Up to 3 days
Secondary	Fold change of international normalized ratio from baseline	Fold change of international normalized ratio from baseline	Up to 3 days