NCT04480762

A Trial of SHR-1703 in Healthy Adults

A Randomised, Double Blind, Placebo Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-1703 Injection Administered Subcutaneously in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

SHR-1703 is a monoclonal antibody under development for severe asthma. This study is the first study in Healthy subjects. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose SHR-1703 administered subcutaneously in Chinese healthy subjects.

Detailed description

This study will be conducted at 1 study center in China. Approximately 42 healthy Chinese male and female subjects, aged 18 to 55 inclusive, will be randomized to receive a single SC administration of SHR-1703: Treatment 1, Treatment 2, Treatment 3, Treatment 4 and Treatment 5. Each subject will participate in only 1 treatment group. The total length of the study for each subject is up to 190 days (28 days of screening and 155+/- 7 days of further study visits).

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	SHR-1703	SHR-1703
DRUG	Placebo	Placebo of the SHR-1703

Timeline

• Start date: 2020-08-04
• Primary completion: 2021-09-21
• Completion: 2021-09-21
• First posted: 2020-07-21
• Last updated: 2022-11-14

Locations

1 site across 1 country: China