Phase Ⅰ Clinical Trial of Gerilimzumab Injection in Healthy Subjects

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

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

Sponsors & Collaborators

• Genor Biopharma Co., Ltd.

  lead INDUSTRY

Principal Investigators

• Yi Fang, Ph.D · Peking University People's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-11-06

Primary Completion

2020-12-31

Completion

2021-04-30

Countries

• China

Study Locations