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

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

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: SHR-1819; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Changsha
    • Changsha, Changsha, China, 410013
      • The Third Xiangya Hospital of Central South University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Treatment group A	Drug: SHR-1819; SHR-1819 will be subcutaneously administered with different dose levels;
PLACEBO_COMPARATOR: Treatment group B	Drug: Placebo; Placebo will be subcutaneously administered with different dose levels;

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Incidence and severity of adverse events	Start of Treatment to end of study（about 13 weeks）

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics-AUC0-inf	Area under the concentration-time curve from time 0 to infinity after SHR-1819 administration	Start of Treatment to end of study (approximately 13 weeks)
Pharmacokinetics-Tmax	Time to Cmax of SHR-1819	Up to 13 weeks
Pharmacokinetics-Cmax	Maximum observed concentration of SHR-1819	Up to 13 weeks
Pharmacokinetics-CL/F	Apparent clearance of SHR-1819	Up to 13 weeks
Pharmacokinetics-Vz/F	Apparent volume of distribution during terminal phase of SHR-1819	Up to 13 weeks
Pharmacokinetics-t1/2	Terminal elimination half-life of SHR-1819	Up to 13 weeks
Change from baseline to end of treatment for IgE	IgE	Up to 13 weeks
Pharmacokinetics-AUC0-last	Area under the concentration-time curve from time 0 to last time point after SHR-1819 administration	Start of Treatment to end of study (about 13 weeks)
Change from baseline to end of treatment for Thymus and activation-regulated chemokine（TARC/CCL17）	Thymus and activation-regulated chemokine（TARC/CCL17）	Up to 13 weeks
Immunogenicy of SHR-1819 after administration	Anti-drug antibody	Up to 13 weeks]
Pharmacokinetics-AUCtau for multi-dose	Area under the concentration-time curve from time 0 to last time point after SHR-1819 administration	Start of Treatment to end of study (about 13 weeks)
Pharmacokinetics- Ctrough for multi-dose	Minimum observed concentration of SHR-1819	Up to 13 weeks
Pharmacokinetics- Racc for multi-dose	Accumulation ratio of SHR-1819	Up to 13 weeks

Collaborators and Investigators

• Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2021
• Primary Completion (ACTUAL): December 10, 2021
• Study Completion (ACTUAL): December 10, 2021

Study Registration Dates

• First Submitted: February 22, 2021
• First Submitted That Met QC Criteria: February 25, 2021
• First Posted (ACTUAL): February 26, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 29, 2022
• Last Update Submitted That Met QC Criteria: November 28, 2022
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: SHR-1819-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No