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

NCT04772365 | Completed Phase 1

• 1 other identifier: SHR-1819-101
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Adverse events

  Incidence and severity of adverse events

  Start of Treatment to end of study（about 13 weeks）

Secondary Outcomes (13)

• Pharmacokinetics-AUC0-last

  Start of Treatment to end of study (about 13 weeks)

• Pharmacokinetics-AUC0-inf

  Start of Treatment to end of study (approximately 13 weeks)

• Pharmacokinetics-Tmax

  Up to 13 weeks

• Pharmacokinetics-Cmax

  Up to 13 weeks

• Pharmacokinetics-CL/F

  Up to 13 weeks

Study Arms (2)

Treatment group A

EXPERIMENTAL

Drug: SHR-1819

Treatment group B

PLACEBO COMPARATOR

Drug: Placebo

Interventions

SHR-1819 DRUG

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

Treatment group A

Placebo DRUG

Placebo will be subcutaneously administered with different dose levels;

Treatment group B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Hengrui Pharmaceutical Co., Ltd.: lead

Study Sites (1)

The Third Xiangya Hospital of Central South University

Changsha, Changsha, 410013, China

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: February 26, 2021
• Study Start: March 1, 2021
• Primary Completion: December 10, 2021
• Study Completion: December 10, 2021
• Last Updated: November 29, 2022

Record last verified: 2021-02

Locations

CN (1)