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

NCT ID: NCT05954611

Last Updated: 2024-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-16

Study Completion Date

2024-01-02

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.

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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GR2002 injection

GR2002 subcutaneous injection

Group Type EXPERIMENTAL

GR2002 injection

Intervention Type BIOLOGICAL

one single dose of GR2002 injection

placebo

placebo subcutaneous injection

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

one single dose of placebo

Interventions

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GR2002 injection

one single dose of GR2002 injection

Intervention Type BIOLOGICAL

Placebo

one single dose of placebo

Intervention Type BIOLOGICAL

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Genrix (Shanghai) Biopharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yi Fang, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Locations

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Peking University People's Hospital

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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GR2002-001

Identifier Type: -

Identifier Source: org_study_id

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