NCT04561128

A Trial of SHR-1819 in Healthy Subjects

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Administered SHR-1819 in Healthy Subjects

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

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	SHR-1819	SHR-1819 will be subcutaneously administered with different dose levels
DRUG	Placebo	Placebo will be subcutaneously administered with different dose levels

Timeline

• Start date: 2020-11-01
• Primary completion: 2022-03-07
• Completion: 2022-03-07
• First posted: 2020-09-23
• Last updated: 2022-07-12

Locations

1 site across 1 country: Australia