A Trial of SHR2285 in Healthy Subjects

NCT ID: NCT04829305

Last Updated: 2022-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-20
• Study Completion Date: 2021-09-06

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

Conditions

Healthy Volunteers

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Low dose of SHR2285

The subjects will receive a single dose of SHR2285 (cohort 1).

Group Type: EXPERIMENTAL

SHR2285

Intervention Type: DRUG

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

Medium dose of SHR2285

The subjects will receive a single dose of SHR2285 (cohort 2).

Group Type: EXPERIMENTAL

SHR2285

Intervention Type: DRUG

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

High dose of SHR2285

The subjects will receive a single dose of SHR2285 (cohort 3).

Group Type: EXPERIMENTAL

SHR2285

Intervention Type: DRUG

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

Interventions

SHR2285

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Atridia Pty Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr Jasmine Daisy Williams

Role: PRINCIPAL_INVESTIGATOR

Study Principal Investigator

Locations

Linear Clinical research

Perth, Western Australia, Australia

Countries

Australia

Other Identifiers

SHR2285-105

Identifier Type: -

Identifier Source: org_study_id