A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Dose Escalation Study in Healthy Subjects

Hengrui Medicine

Status and phase: Completed; Phase 1

Conditions: Asthma

Treatments: Drug: SHR-1819; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04772365

SHR-1819-101

Details and patient eligibility

About

This is a single center, randomized, double-blind, placebo-controlled, single and multiple 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: 52 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Ability to understand the trial procedures and possible adverse events, volunteers to participate in the trial, and provides written informed consent.
2. Be able to comply with all the requirements and able to complete the study.
3. Male or female aged between 18 years and 55 years (inclusive) at the date of signed consent form.
4. No clinically significant abnormalities in medical history, general physical examination, vital signs, and laboratory tests.
5. 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

1. Positive hepatitis B virus (HBsAg), hepatitis C virus (HCV-Ab), human immunodeficiency virus (HIV-Ab), or QuantiFERON-TB Gold tests at screening;
2. 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
3. Severe injuries or surgeries within 6 months before screening or plan to do surgeries during the trial
4. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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52 participants in 2 patient groups, including a placebo group

Treatment group A

Experimental group

Treatment:

Drug: SHR-1819

Treatment group B

Placebo Comparator group

Treatment:

Drug: Placebo