A Trial of SHR8735 in Healthy Subjects

NCT04701216 | Completed Phase 1 DMC

• 1 other identifier: SHR8735-I-113
• Study Type: interventional
• Target: 48
• 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 28 days)

Secondary Outcomes (8)

• Pharmacokinetics-AUC0-last

  Start of Treatment to end of study (approximately 15 days)

• Pharmacokinetics-AUC0-inf

  Start of Treatment to end of study (approximately 15 days)

• Pharmacokinetics-Tmax

  Up to 15 days

• Pharmacokinetics-Cmax

  Up to 15 days

• Pharmacokinetics-CL/F

  Up to 15 days

Study Arms (3)

Experimental: SHR8735 cohort 1

EXPERIMENTAL

The subjects will receive a multiple dose of SHR8735 (low dose).

Drug: SHR8735

Experimental: SHR8735 cohort 2

EXPERIMENTAL

The subjects will receive a single dose of SHR8735 (medium dose).

Drug: SHR8735

Experimental: SHR8735 cohort 3

EXPERIMENTAL

The subjects will receive a single dose of SHR8735 (high dose).

Drug: SHR8735

Interventions

SHR8735 DRUG

SHR8735 is an thrombopoietin receptor agonist to promote platelet production.

Experimental: SHR8735 cohort 1; Experimental: SHR8735 cohort 2; Experimental: SHR8735 cohort 3

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).
• Severe, active psychiatric conditions that require ongoing treatment.

Sponsors & Collaborators

• Atridia Pty Ltd.: lead

Study Sites (1)

Linear Clinical research

Perth, Western Australia, 6009, Australia

Location

Study Officials

• Ana Sun, Dr

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 6, 2021
• First Posted: January 8, 2021
• Study Start: February 11, 2021
• Primary Completion: July 15, 2021
• Study Completion: July 15, 2021
• Last Updated: November 9, 2021

Record last verified: 2021-11

Locations

AU (1)