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

NCT ID: NCT04772365

Last Updated: 2022-11-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2021-12-10

Brief Summary

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

Conditions

Asthma

Study Design

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

Study Groups

Treatment group A

Group Type: EXPERIMENTAL

SHR-1819

Intervention Type: DRUG

SHR-1819 will be subcutaneously administered with different dose levels;

Treatment group B

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai Hengrui Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Third Xiangya Hospital of Central South University

Changsha, Changsha, China

Countries

China

Other Identifiers

SHR-1819-101

Identifier Type: -

Identifier Source: org_study_id