A Study to Evaluate the Safety, Immunogenicity, and Pharmacokinetics of GR2303 in Healthy Adult

Genrix (Shanghai) Biopharmaceutical

Status and phase: Enrolling; Phase 1

Conditions: Health Adult Subjects

Treatments: Biological: Placebo; Biological: GR2303 injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT07199270

GR2303-001

Details and patient eligibility

About

he goal this clinical trail is to evaluate the safety、Pharmacokinetic and immunogenicity of GR2303 injection。 Subjects will be enrolled in different groups in sequential order, and within each group will be randomly assigned to receive either GR2303 injection or placebo administration, with each Subjects will be enrolled in only one of these groups

Full description

This is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and preliminary pharmacodynamic profile of GR2303 Injection in healthy adult Chinese subjects.

After signing the informed consent form, subjects who meet the criteria for enrollment will be entered into different groups according to the randomization number. Subjects will be enrolled in only one of these groups.

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy adult subjects
2. Signed informed consent

Exclusion criteria

1. History or presence of any clinically significant organ system disease that could interfere with the objectives of the study or the safety of the subjects.
2. Prior use of drug targeting TNF-like cytokine 1A
3. history of malignant tumor
4. psitive results for Hepatitis B surface antigen (HBsAg), anti Hepatitis C antibody (HCV Ab) or human immunodeficiency virus (HIV)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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64 participants in 8 patient groups

group 1

Experimental group

Description:

single dose

Treatment:

Biological: Placebo

Biological: GR2303 injection

Biological: Placebo

Biological: GR2303 injection

group 2

Experimental group

Description:

single dose

Treatment:

Biological: Placebo

Biological: GR2303 injection

Biological: Placebo

Biological: GR2303 injection

group 3

Experimental group

Description:

single dose

Treatment:

Biological: Placebo

Biological: GR2303 injection

Biological: Placebo

Biological: GR2303 injection

group 4

Experimental group

Description:

single dose

Treatment:

Biological: Placebo

Biological: GR2303 injection

Biological: Placebo

Biological: GR2303 injection

group 5

Experimental group

Description:

single dose

Treatment:

Biological: Placebo

Biological: GR2303 injection

Biological: Placebo

Biological: GR2303 injection

group 6

Experimental group

Description:

multiple dose

Treatment:

Biological: Placebo

Biological: GR2303 injection

Biological: Placebo

Biological: GR2303 injection

group 7

Experimental group

Description:

multiple dose

Treatment:

Biological: Placebo

Biological: GR2303 injection

Biological: Placebo

Biological: GR2303 injection

group 8

Experimental group

Description:

multiple dose

Treatment:

Biological: Placebo

Biological: GR2303 injection

Biological: Placebo

Biological: GR2303 injection