NCT06313697

Brief Summary

the goal this clinical trail is to evaluate the safety、Pharmacokinetic and immunogenicity of GR2102 injection。 Subjects will be enrolled in different groups in sequential order, and within each group will be randomly assigned to receive either GR2102 injection or placebo administration, with each Subjects will be enrolled in only one of these groups。

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
132

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

March 5, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 15, 2024

Completed
8 days until next milestone

Study Start

First participant enrolled

March 23, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2025

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2025

Completed
Last Updated

August 22, 2024

Status Verified

March 1, 2024

Enrollment Period

10 months

First QC Date

March 5, 2024

Last Update Submit

August 20, 2024

Conditions

Respiratory Syncytial Virus Infections

Keywords

respiratory syncytial virusRSVrespiratory infection

Outcome Measures

Primary Outcomes (1)

  • Adverse events

    to characterise the safety and tolerability of GR2102,including abnormal vital signs,laboratory tests,electrocardiogram and physical examination

    150 days post dose

Secondary Outcomes (3)

  • Maximum Observed Serum Concentration

    150 days post dose

  • Terminal Elimination Half Life

    150 days post dose

  • anti-respiratory syncytial virus neutralizing antibodies titer levels

    150 days post dose

Study Arms (6)

Treatment group 1

EXPERIMENTAL

single dose

Biological: GR2102 injectionBiological: placebo

Treatment group 2

EXPERIMENTAL

single dose

Biological: GR2102 injectionBiological: placebo

Treatment group 3

EXPERIMENTAL

single dose

Biological: GR2102 injectionBiological: placebo

Treatment group 4

EXPERIMENTAL

single dose

Biological: GR2102 injectionBiological: placebo

Treatment group 5

EXPERIMENTAL

single dose

Biological: GR2102 injectionBiological: placebo

Treatment group 6

EXPERIMENTAL

single dose

Biological: GR2102 injectionBiological: placebo

Interventions

GR2102 injectionBIOLOGICAL

single dose

Treatment group 1Treatment group 2Treatment group 3Treatment group 4Treatment group 5Treatment group 6
placeboBIOLOGICAL

single dose

Treatment group 1Treatment group 2Treatment group 3Treatment group 4Treatment group 5Treatment group 6

Eligibility Criteria

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

You may qualify if:

  • Healthy adult subjects
  • Signed informed consent

You may not qualify if:

  • Signs and symptoms of upper respiratory tract infection prior to randomization
  • Prior use of RSV vaccine or RSV antibody-based medications
  • history of malignant tumor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Shandong First Medical University

Jinan, Shandong, 250102, China

RECRUITING

MeSH Terms

Conditions

Respiratory Syncytial Virus InfectionsRespiratory Tract Infections

Condition Hierarchy (Ancestors)

Pneumovirus InfectionsParamyxoviridae InfectionsMononegavirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsRespiratory Tract Diseases

Study Officials

  • wei zhao, PHD

    Shandong First Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

wei zhao, PHD

CONTACT

15131190710zhao4wei@hotmail.com

juan huang, MD

CONTACT

19301494061huangjuan@genrixbio.com

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

March 5, 2024

First Posted

March 15, 2024

Study Start

March 23, 2024

Primary Completion

January 6, 2025

Study Completion

December 6, 2025

Last Updated

August 22, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)