NCT04800263

A Trial of SHR-1905 in Healthy Subjects

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (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 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.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	SHR-1905	SHR-1905 will be injected subcutaneously
DRUG	Placebo	Placebo will be injected subcutaneously

Timeline

• Start date: 2021-07-27
• Primary completion: 2022-11-12
• Completion: 2022-11-12
• First posted: 2021-03-16
• Last updated: 2023-05-10

Locations

1 site across 1 country: Australia