A Trial of SHR-1819 in Healthy Subjects

NCT ID: NCT04561128

Last Updated: 2022-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-01
• Study Completion Date: 2022-03-07

Brief Summary

This is a single center, randomized, double-blind, placebo-controlled, single dose escalation phase 1 study.

Detailed Description

This is a single center, randomized, double-blind, placebo-controlled, single dose escalation phase 1 study. The objective of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous administered SHR-1819 in healthy subjects.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

SHR-1819

Experimental: SHR-1819

Group Type: EXPERIMENTAL

SHR-1819

Intervention Type: DRUG

SHR-1819 will be subcutaneously administered with different dose levels

Placebo

Placebo comparator: placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo will be subcutaneously administered with different dose levels

Interventions

SHR-1819

SHR-1819 will be subcutaneously administered with different dose levels

Intervention Type: DRUG

Placebo

Placebo will be subcutaneously administered with different dose levels

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

• Positive hepatitis B virus (HBsAg), hepatitis C virus (HCV-Ab), human immunodeficiency virus (HIV-Ab), or QuantiFERON-TB Gold tests at screening;
• Participation in clinical trials of other investigational drugs or medical devices within 3 months prior to screening (according to the date of signed consent form), or in the follow-up period of a clinical study
• Severe injuries or surgeries within 6 months before screening or plan to do surgeries during the trial
• Any other circumstances that, in the investigator's judgment, may increase the risk associated with the subject's participation in and completion of the study or could preclude the evaluation of the subject's response

• 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

Locations

Atridia Pty Limited

Sydney, New South Wales, Australia

Countries

Australia

Other Identifiers

SHR-1819-I-101-AUS

Identifier Type: -

Identifier Source: org_study_id