A Trial of SHR8735 in Healthy Subjects

Atridia

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: SHR8735

Study type: Interventional

Funder types: Industry

Identifiers

NCT04701216

SHR8735-I-113

Details and patient eligibility

About

This is a phase 1 open-label study.

Full 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 SHR8735 in healthy subjects

Enrollment: 48 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 3 patient groups

Experimental: SHR8735 cohort 1

Experimental group

Description:

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

Treatment:

Drug: SHR8735

Experimental: SHR8735 cohort 2

Experimental group

Description:

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

Treatment:

Drug: SHR8735

Experimental: SHR8735 cohort 3

Experimental group

Description:

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

Treatment:

Drug: SHR8735