NCT04179513

A Study to Evaluate the Safety and Tolerability of Multiple Doses of Gerilimzumab in Rheumatoid Arthritis Patients

Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of Gerilimzumab for Injection in Combination With Oral Methotrexate in Rheumatoid Arthritis Patients in Two Dose Groups

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Genor Biopharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the safety, tolerability and pharmacokinetic (PK) profiles of multiple abdominal subcutaneous injection of GB224 in combination with oral methotrexate in Chinese patients with moderate and severe active rheumatoid arthritis in two dose groups; the secondary objectives are to preliminarily evaluate the clinical efficacy such as ACR20 at week 32, ACR20, ACR50 and ACR70 at weeks 12 and 24, ACR50 and ACR70 at week 32, and DAS28 at weeks 12, 24 and 32 of multiple abdominal subcutaneous injection of GB224 in combination with oral methotrexate in Chinese patients with moderate and severe active rheumatoid arthritis in two dose groups as well as to preliminarily understand the immunogenicity and changes in pharmacodynamic variable (IL-6) of multiple abdominal subcutaneous injection of GB224 in combination with oral methotrexate in Chinese patients with moderate and severe active rheumatoid arthritis in two dose groups.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
BIOLOGICAL	GB224 10mg	10 mg, 12subjects, abdominal subcutaneous injection, the next dose group can be initiated only after the safety and tolerability are confirmed within 4 weeks after the second dosing is given. Dosage and administration at enrollment are maintained (10\~15 mg/week), oral administration, a total of 32 doses.
BIOLOGICAL	GB224 20mg	20 mg, 12subjects, abdominal subcutaneous injection, the next dose group can be initiated only after the safety and tolerability are confirmed within 4 weeks after the second dosing is given. Dosage and administration at enrollment are maintained (10\~15 mg/week), oral administration, a total of 32 doses.

Timeline

• Start date: 2019-08-15
• Primary completion: 2020-12-01
• Completion: 2021-04-01
• First posted: 2019-11-27
• Last updated: 2019-11-27

Locations

1 site across 1 country: China