A Trial of SHR-1819 in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Placebo; Drug: SHR-1819

• Registration Number: NCT04561128
• Lead Sponsor: Atridia Pty Ltd.

Brief Summary

This is a single center, randomized, double-blind, placebo-controlled, single dose escalation phase 1 study.

Detailed Description

This is a single center, randomized, double-blind, placebo-controlled, single 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 Timeline

• Study First Submitted: 2020-08-29
• Study First Submitted QC: 2020-09-17
• Study First Posted: 2020-09-23
• Study Start: 2020-11-01
• Primary Completion: 2022-03-07
• Study Completion: 2022-03-07
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-11
• Last Update Posted: 2022-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo comparator: placebo
SHR-1819	SHR-1819	Experimental: SHR-1819

Primary Outcome Measures

Name	Time	Method
Adverse events	Start of Treatment to end of study (approximately 13 weeks)	Incidence and severity of adverse events

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics-AUC0-last	Start of Treatment to end of study (approximately 13 weeks)	Area under the concentration-time curve from time 0 to last time point after SHR-1819 administration
Pharmacokinetics-Vz/F	Up to 13 weeks	Apparent volume of distribution during terminal phase of SHR-1819
Pharmacokinetics-t1/2	Up to 13 weeks	Terminal elimination half-life of SHR-1819
Pharmacokinetics-AUC0-inf	Start of Treatment to end of study (approximately 13 weeks)	Area under the concentration-time curve from time 0 to infinity after SHR-1819 administration
Change from baseline to end of treatment for IgE	Up to 13 weeks	IgE
Pharmacokinetics-Tmax	Up to 13 weeks	Time to Cmax of SHR-1819
Pharmacokinetics-Cmax	Up to 13 weeks	Maximum observed concentration of SHR-1819
Pharmacokinetics-CL/F	Up to 13 weeks	Apparent clearance of SHR-1819
Change from baseline to end of treatment for TARC/CCL17	Up to 13 weeks	TARC/CCL17
Immunogenicy of SHR-1819 after administration	Up to 13 weeks	Anti-drug antibody

Trial Locations

Locations (1)

Atridia Pty Limited; 🇦🇺 Sydney, New South Wales, Australia