A Phase 1, Randomized, Double-Blind, Placebo-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of Single Subcutaneous Administered SHR-1905 in Healthy Subjects

Atridia Pty Ltd.1 site in 1 country50 target enrollmentJuly 27, 2021

ConditionsAsthma

InterventionsSHR-1905 Placebo

Overview

Phase: Phase 1
Intervention: SHR-1905
Conditions: Asthma
Sponsor: Atridia Pty Ltd.
Enrollment: 50
Locations: 1
Primary Endpoint: Adverse events
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a randomized, double-blind, placebo-controlled, single dose escalation phase 1 study. The objective of this study is to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of subcutaneous administered SHR-1905 in healthy subjects.

Detailed Description

The study will consist of one dose esclation part with a total of 5 dose levels. The Subjects will be randomized to receive SHR-1905 as reflected by the guiding principle for the dose esclation/expansion phase. Each dose group includes a screening period, a baseline period, an observational period, and a safety follow-up period.

Registry

clinicaltrials.gov

Start Date

July 27, 2021

End Date

November 12, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Atridia Pty Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Ability to understand the trial procedures and possible adverse events, volunteers to participate in the trial.
•Male or female aged between 18 years and 55 years (inclusive) at the date of signed consent form.
•Total body weight ≥45 kg at screening, and body mass index (BMI) between 18 and 28 kg/m2 (inclusive).
•For healthy subjects, no clinically significant abnormalities.
•Men and women of childbearing potential (WOCBP) must agree to take effective contraceptive methods

Exclusion Criteria

•Known medical history of severe disease in cardiovascular, liver, kidney, digestive tract, mental nerve, hematology, metabolic disorders, etc.
•Severe injuries or major surgeries within 6 months before screening.
•Subjects with infecious disease.
•Hyper/Hypotension at screening and at check in.
•Clinically significant abnormalities in 12-Lead ECG
•More than 5 cigarettes daily (or products with equivalent amount of nicotine) for 3 months prior to screening
•Positive urine drug screen .
•Subject who cannot perform venous blood sampling.
•Known history or suspected of being allergic to the study drugs and their excipients.
•Use of any medicine within 4-weeks or within 5 half-lives

Intervention: Placebo

Outcomes

Primary Outcomes

Adverse events

Time Frame: Start of Treatment to end of study (approximately 16 weeks)

Incidence and severity of adverse events

Secondary Outcomes

Pharmacokinetics-AUC0-last(Start of Treatment to end of study (approximately 16 weeks))
Pharmacokinetics-Tmax(Start of Treatment to end of study (approximately 16 weeks))
Pharmacokinetics-CL/F(Start of Treatment to end of study (approximately 16 weeks))
Pharmacokinetics-Cmax(Start of Treatment to end of study (approximately 16 weeks))
Pharmacokinetics-AUC0-inf(Start of Treatment to end of study (approximately 16 weeks))
Pharmacokinetics-Vz/F(Start of Treatment to end of study (approximately 16 weeks))
Pharmacokinetics-t1/2(Start of Treatment to end of study (approximately 16 weeks))
Anti-Drug antibody(Start of Treatment to end of study (approximately 16 weeks))