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NCT04772365 | COMPLETED | Asthma

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

Shanghai Hengrui Pharmaceutical Co., Ltd.

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

Condition or disease

Asthma

Intervention/treatment

SHR-1819

Placebo

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 52 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2021-03-01
Estimated Primary Completion Date : 2021-12-10
Estimated Study Completion Date : 2021-12-10

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 55 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Dose Escalation Study in Healthy Subjects

Location Details

NCT04772365

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

China, Changsha

The Third Xiangya Hospital of Central South University

Changsha, Changsha, China, 410013