The Study of Single Dose Administration of GR2002 Injection in Chinese Health Volunteers

Genrix (Shanghai) Biopharmaceutical

Status and phase: Completed; Phase 1

Conditions: Asthma

Treatments: Biological: GR2002 injection; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05954611

GR2002-001

Details and patient eligibility

About

To evaluate the pharmacokinetic (PK) characteristics and pharmacological effect of GR2002 injection in Chinese healthy volunteers

Full description

This is a randomized, double-blind, placebo-controlled phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, preliminary pharmacodynamics, and immunogenicity characteristics of single subcutaneous administration of GR2002 injection in healthy adult Chinese subjects.

The initial dose group is 35mg, and the subsequent doses will gradually increase. Only after all subjects in the current dose group have completed at least 2 weeks of safety and tolerance observation and confirmed safe tolerance, can they enter the next dose group for medication observation until the "dose increase termination standard" is reached.

Follow up will be conducted for at least 12 weeks ± 3 days after completion of medication administration.

Enrollment: 50 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 1. Age of 18 to 55 years, inclusive, male or female 2. BMI between 19 kg/m2 and 26 kg/m2 (inclusive) 3. Healthy volunteers

Exclusion criteria

• 1. History of chronic disease or serious disease 2. Subject with severe psychological or mental illness 3. Not enough washing-out period for previous therapy 4. Other.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

GR2002 injection

Experimental group

Description:

GR2002 subcutaneous injection

Treatment:

Biological: GR2002 injection

placebo

Placebo Comparator group

Description:

placebo subcutaneous injection

Treatment:

Biological: Placebo