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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05954611

Enrollment

Registered

2023-07-20

Start date

2023-06-16

Completion date

2024-01-02

Last updated

2024-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

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.

Interventions

BIOLOGICALGR2002 injection

one single dose of GR2002 injection

BIOLOGICALPlacebo

one single dose of placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026