The Study of Single Dose Administration of GR2002 Injection in Chinese Health Volunteers
Phase 1
Completed
- Conditions
- Asthma
- Registration Number
- NCT05954611
- Lead Sponsor
- Genrix (Shanghai) Biopharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Inclusion Criteria:<br><br> - <br><br> 1. Age of 18 to 55 years, inclusive, male or female 2. BMI between 19 kg/m2 and 26<br> kg/m2 (inclusive) 3. Healthy volunteers<br><br>Exclusion Criteria:<br><br> - <br><br> 1. History of chronic disease or serious disease 2. Subject with severe<br> psychological or mental illness 3. Not enough washing-out period for previous<br> therapy 4. Other.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of Adverse Events (AE)
- Secondary Outcome Measures
Name Time Method Pharmacokinetics (PK) parameter: Time to reach peak concentration (Tmax);Pharmacokinetics (PK) parameter : Peak Plasma concentration (Cmax);Pharmacodynamics (PD): Changes from baseline in serum thymus activation regulation chemokine (TARC) concentration after GR2002 administration;Immunogenicity: anti-drug antibody (ADA) and neutralizing antibody (Nab)