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A Trial of SHR8735 in Healthy Subjects

NCT ID: NCT04701216

Last Updated: 2021-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-11

Study Completion Date

2021-07-15

Brief Summary

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This is a phase 1 open-label study.

Detailed Description

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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 SHR8735 in healthy subjects

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental: SHR8735 cohort 1

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

Group Type EXPERIMENTAL

SHR8735

Intervention Type DRUG

SHR8735 is an thrombopoietin receptor agonist to promote platelet production.

Experimental: SHR8735 cohort 2

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

Group Type EXPERIMENTAL

SHR8735

Intervention Type DRUG

SHR8735 is an thrombopoietin receptor agonist to promote platelet production.

Experimental: SHR8735 cohort 3

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

Group Type EXPERIMENTAL

SHR8735

Intervention Type DRUG

SHR8735 is an thrombopoietin receptor agonist to promote platelet production.

Interventions

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SHR8735

SHR8735 is an thrombopoietin receptor agonist to promote platelet production.

Intervention Type DRUG

Eligibility Criteria

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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).
* Severe, active psychiatric conditions that require ongoing treatment.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Atridia Pty Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ana Sun, Dr

Role: PRINCIPAL_INVESTIGATOR

Study Principal Investigator

Locations

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Linear Clinical research

Perth, Western Australia, Australia

Site Status

Countries

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Australia

Other Identifiers

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SHR8735-I-113

Identifier Type: -

Identifier Source: org_study_id