A Trial of SHR-1819 in Healthy Subjects

Atridia

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: Placebo

Drug: SHR-1819

Study type

Interventional

Funder types

Industry

Identifiers

NCT04561128

SHR-1819-I-101-AUS

Details and patient eligibility

About

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

Full 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.

Enrollment

42 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

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