NCT04178070

Phase Ⅰ Clinical Trial of Gerilimzumab Injection in Healthy Subjects

A Randomized, Double-blind, Placebo-controlled, Single Dose, Dose-escalated Phase Ⅰ Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Gerilimzumab in Healthy Adult Subjects.

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: Genor Biopharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The primary objectives of this study are to evaluate the safety, tolerability and pharmacokinetic (PK) profiles of single-dose, dose-escalated, abdominal subcutaneous injection of GB224 in Chinese healthy adult subjects. The secondary objectives are to preliminarily understand the immunogenicity and pharmacodynamic variable (IL-6) of single abdominal subcutaneous injection of GB224 in Chinese healthy adult subjects.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
BIOLOGICAL	GB224 2mg	2mg (100μL), single dose, abdominal subcutaneous injection
BIOLOGICAL	GB224 5mg	5mg (250μL), single dose, abdominal subcutaneous injection
BIOLOGICAL	GB224 10mg	10mg (500μL), single dose, abdominal subcutaneous injection
BIOLOGICAL	GB224 15mg	15mg (750μL), single dose, abdominal subcutaneous injection
BIOLOGICAL	GB224 20mg	20mg (1mL), single dose, abdominal subcutaneous injection
BIOLOGICAL	GB224 30mg	30mg (1.5mL), single dose, abdominal subcutaneous injection
OTHER	Placebo, 2mg	2mg (100μL), single dose, abdominal subcutaneous injection
OTHER	Placebo, 5mg	5mg (250μL), single dose, abdominal subcutaneous injection
OTHER	Placebo, 10mg	10mg (500μL), single dose, abdominal subcutaneous injection
OTHER	Placebo, 15mg	15mg (750μL), single dose, abdominal subcutaneous injection
OTHER	Placebo, 20mg	20mg (1mL), single dose, abdominal subcutaneous injection
OTHER	Placebo, 30mg	30mg (1.5mL), single dose, abdominal subcutaneous injection

Timeline

• Start date: 2017-11-06
• Primary completion: 2020-12-01
• Completion: 2021-04-01
• First posted: 2019-11-26
• Last updated: 2019-11-27

Locations

1 site across 1 country: China