NCT05328531

Clinical Study of Genakumab for Injection in Patients With Acute Gout

The Phase Ib/II Clinical Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of Genakumab for Injection in Patients With Acute Gout

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and tolerability of single subcutaneous injection of Genakumab for Injection in patients with acute gout

Detailed description

Phase Ib: single arm, open lable, single dose, dose escalation,design. There are 3 dose groups with 10 participant s in each group. Phase II: randomized, double-blind, active control design.There are 2 dose groups of Genakumab for Injection with 30 participant s in each group and 1 group of Compound Betamethasone Injection with 30 praticipants.

Conditions

• Acute Gout

Interventions

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

Timeline

• Start date: 2021-05-22
• Primary completion: 2022-06-09
• Completion: 2022-06-09
• First posted: 2022-04-14
• Last updated: 2025-02-27

Locations

1 site across 1 country: China