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A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Dose Escalation Study in Healthy Subjects | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Administered SHR-1819 in Healthy Subjects

NCT04772365•Shanghai Hengrui Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

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

Locations (1)

The Third Xiangya Hospital of Central South University

Changsha, Changsha, China

Key Dates

Start Date

March 1, 2021

Primary Completion Date

December 10, 2021

Completion Date

December 10, 2021

Last Updated

November 29, 2022

Enrollment

ACTUAL participants

Conditions

Asthma

Interventions

SHR-1819

DRUG

Placebo

DRUG

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

NCT07486401

Asthma ExacerbationsBiomarkers / Blood+1 more

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RECRUITING

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

NCT02327897

Asthma

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 29, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma

Relationship of Airway Microbiota, Endotype and Phenotype in Adult Asthma

To Assess the Management of Patients on Global Initiative of Asthma (GINA) Step 4 and 5 Treatment in Hong Kong

A Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults With Asthma