A Trial of SHR2285 in Healthy Subjects

NCT04829305 | Completed Phase 1 DMC

• 1 other identifier: SHR2285-105
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase 1 open-label study

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Adverse events

  Incidence and severity of adverse events

  Start of Treatment to end of study (approximately 7 days)

Secondary Outcomes (15)

• Pharmacokinetics-AUC0-last

  Start of Treatment to outpatient (approximately 3 days)

• Pharmacokinetics-AUC0-inf

  Start of Treatment to outpatient (approximately 3 days)

• Pharmacokinetics-Tmax

  Up to 3 days

• Pharmacokinetics-Cmax

  Up to 3 days

• Pharmacokinetics-CL/F

  Up to 3 days

Study Arms (3)

Low dose of SHR2285

EXPERIMENTAL

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

Drug: SHR2285

Medium dose of SHR2285

EXPERIMENTAL

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

Drug: SHR2285

High dose of SHR2285

EXPERIMENTAL

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

Drug: SHR2285

Interventions

SHR2285 DRUG

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

High dose of SHR2285; Low dose of SHR2285; Medium dose of SHR2285

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Atridia Pty Ltd.: lead

Study Sites (1)

Linear Clinical research

Perth, Western Australia, 6009, Australia

Location

Study Officials

• Dr Jasmine Daisy Williams

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Three different cohorts can enroll healthy Caucasian participants; males and females in each cohort separately.

Study Record Dates

• First Submitted: March 30, 2021
• First Posted: April 2, 2021
• Study Start: May 20, 2021
• Primary Completion: September 6, 2021
• Study Completion: September 6, 2021
• Last Updated: March 8, 2022

Record last verified: 2022-02

Locations

AU (1)