NCT04855591

A Trial of SHR-1703 in Healthy Subjects

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Dose-Escalation Study to Evaluate the Safety, Tolerability, PK, PD and Immunogenicity of Single Subcutaneous Administered SHR-1703 in Healthy Caucasian Subjects

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Atridia Pty Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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 pharmacodynamics and immunogenicity of subcutaneous administered SHR-1703 in healthy subjects.

Detailed description

The study will consist of one dose esclation part with a total of 3 dose levels. The Subjects will be randomized to receive SHR-1703 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.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	SHR-1703	SHR-1703 will be administered subcutaneously
DRUG	Placebo	Placebo of SHR-1703 will be administered subcutaneously

Timeline

• Start date: 2021-06-14
• Primary completion: 2021-09-13
• Completion: 2021-11-18
• First posted: 2021-04-22
• Last updated: 2021-12-01

Locations

1 site across 1 country: Australia