NCT05954611

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1 asthma

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2023

Completed
21 days until next milestone

Study Start

First participant enrolled

June 16, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 20, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2024

Completed
Last Updated

August 22, 2024

Status Verified

August 1, 2024

Enrollment Period

7 months

First QC Date

May 26, 2023

Last Update Submit

August 20, 2024

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Pharmacokinetics (PK) parameter: Time to reach peak concentration (Tmax)

    85 days

  • Pharmacokinetics (PK) parameter : Peak Plasma concentration (Cmax)

    85 days

  • Pharmacodynamics (PD): 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)

    85 days

Study Arms (2)

GR2002 injection

EXPERIMENTAL

GR2002 subcutaneous injection

Biological: GR2002 injection

placebo

PLACEBO COMPARATOR

placebo subcutaneous injection

Biological: Placebo

Interventions

GR2002 injectionBIOLOGICAL

one single dose of GR2002 injection

GR2002 injection
PlaceboBIOLOGICAL

one single dose of placebo

placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \. Age of 18 to 55 years, inclusive, male or female 2. BMI between 19 kg/m2 and 26 kg/m2 (inclusive) 3. Healthy volunteers

You may not qualify if:

  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University People's Hospital

Beijing, China

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Yi Fang, MD

    Peking University People's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2023

First Posted

July 20, 2023

Study Start

June 16, 2023

Primary Completion

January 2, 2024

Study Completion

January 2, 2024

Last Updated

August 22, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)