A Phase I, Randomized, Blinding, Single-dose, Placebo Control Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics Effect of GR2002 in Chinese Health Volunteers
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Incidence of Adverse Events (AE)
Study Overview
Brief Summary
To evaluate the pharmacokinetic (PK) characteristics and pharmacological effect of GR2002 injection in Chinese healthy volunteers
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •1. Age of 18 to 55 years, inclusive, male or female
- •BMI between 19 kg/m2 and 26 kg/m2 (inclusive)
- •Healthy volunteers
Exclusion Criteria
- •1. History of chronic disease or serious disease
- •Subject with severe psychological or mental illness
- •Not enough washing-out period for previous therapy
Arms & Interventions
GR2002 injection
GR2002 subcutaneous injection
Intervention: GR2002 injection (Biological)
placebo
placebo subcutaneous injection
Intervention: Placebo (Biological)
Outcomes
Primary Outcomes
Incidence of Adverse Events (AE)
Time Frame: 85 days
Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing
Secondary Outcomes
- Pharmacodynamics (PD): Changes from baseline in serum thymus activation regulation chemokine (TARC) concentration after GR2002 administration(85 days)
- Pharmacokinetics (PK) parameter : Peak Plasma concentration (Cmax)(85 days)
- Immunogenicity: anti-drug antibody (ADA) and neutralizing antibody (Nab)(85 days)
- Pharmacokinetics (PK) parameter: Time to reach peak concentration (Tmax)(85 days)