NCT04337437

Clinical Study of Genakumab for Injection in Chinese Healthy Volunteers

The Phase I Clinical Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Genakumab for Injection in Chinese Healthy Volunteers

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

To evaluate the safety and tolerability of single subcutaneous injection of Genakumab for Injection in Chinese healthy adult volunteers

Detailed description

There are 5 dose groups with 8 participants in each group, including 6 participants in the experimental group and 2 participants in the placebo control group. Since the strength of experimental drug is 150mg/1ml/ bottle, participants with a single dose of more than 150mg need to be given subcutaneously at different sites in two or more times

Conditions

• Juvenile Idiopathic Arthritis

Interventions

Type	Name	Description
DRUG	Genakumab	150 mg/1ml/bottle, single subcutaneous injection.
DRUG	Placebo for this trial	The placebo contains other excipients except Genakumab, and its appearance is consistent with that of Genakumab for injection, 150 mg/1ml/bottle, single subcutaneous injection.

Timeline

• Start date: 2019-04-22
• Primary completion: 2020-09-01
• Completion: 2020-09-01
• First posted: 2020-04-07
• Last updated: 2020-04-07

Locations

1 site across 1 country: China