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

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

Detailed Description
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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.

Official Title
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A Phase I, Randomized, Blinding, Single-dose, Placebo Control Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics Effect of GR2002 in Chinese Health Volunteers

Conditions
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Asthma

Intervention / Treatment
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* Biological: GR2002 injection
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GR2002 injection<br>GR2002 subcutaneous injection | Biological: GR2002 injection<br>* one single dose of GR2002 injection<br>|
| Placebo Comparator: placebo<br>placebo subcutaneous injection | Biological: Placebo<br>* one single dose of placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events (AE) | Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing | 85 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK) parameter: Time to reach peak concentration (Tmax) | Time to reach peak concentration (Tmax) | 85 days | 
| Pharmacokinetics (PK) parameter : Peak Plasma concentration (Cmax) | Peak Plasma concentration (Cmax) | 85 days | 
| Pharmacodynamics (PD): Changes from baseline in serum thymus activation regulation chemokine (TARC) concentration after GR2002 administration | Changes from baseline in serum thymus activation regulation chemokine (TARC) concentration after GR2002 administration | 85 days | 
| Immunogenicity: anti-drug antibody (ADA) and neutralizing antibody (Nab) | Detection of anti-drug antibody (ADA) and neutralizing antibody (Nab) | 85 days |