A Study to Evaluate the Safety, Immunogenicity, and Pharmacokinetics of GR2102 in Healthy Adult

August 20, 2024 updated by: Genrix (Shanghai) Biopharmaceutical Co., Ltd.

A Randomized, Double-blind, Placebo-controlled, Single-dose Administration of GR2102 Injection in Healthy Adult Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Pharmacologic of GR2102

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。

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a randomized, double-blind, placebo-controlled, single-dose administration study to evaluate the safety, tolerability, pharmacokinetics, and preliminary pharmacodynamic profile of GR2102 Injection in healthy adult Chinese subjects.

After signing the informed consent form, subjects who meet the criteria for enrollment will be entered into different groups according to the randomization number.Subjects will be enrolled in only one of these groups.

Only after the 8 subjects in the current group have completed at least 7 days of safety and tolerability observations and have been determined to be safe and tolerable, will another group of subjects be allowed to proceed to the next group .

After completion of dosing, follow-up will be at least 150 days.

Study Type

Interventional

Enrollment (Estimated)

132

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250102
        • Recruiting
        • The First Affiliated Hospital of Shandong First Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Healthy adult subjects
  2. Signed informed consent

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment group 1
single dose
Biological: GR2102 injection
single dose
Biological: placebo
single dose
Experimental: Treatment group 2
single dose
Biological: GR2102 injection
single dose
Biological: placebo
single dose
Experimental: Treatment group 3
single dose
Biological: GR2102 injection
single dose
Biological: placebo
single dose
Experimental: Treatment group 4
single dose
Biological: GR2102 injection
single dose
Biological: placebo
single dose
Experimental: Treatment group 5
single dose
Biological: GR2102 injection
single dose
Biological: placebo
single dose
Experimental: Treatment group 6
single dose
Biological: GR2102 injection
single dose
Biological: placebo
single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: 150 days post dose
to characterise the safety and tolerability of GR2102,including abnormal vital signs,laboratory tests,electrocardiogram and physical examination
150 days post dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Observed Serum Concentration
Time Frame: 150 days post dose
Pharmacokinetic indices
150 days post dose
Terminal Elimination Half Life
Time Frame: 150 days post dose
Pharmacokinetic indices
150 days post dose
anti-respiratory syncytial virus neutralizing antibodies titer levels
Time Frame: 150 days post dose
indicator of immunogenicity
150 days post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genrix (Shanghai) Biopharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: wei zhao, PHD, The First Affiliated Hospital of Shandong First Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 23, 2024

Primary Completion (Estimated)

January 6, 2025

Study Completion (Estimated)

December 6, 2025

Study Registration Dates

First Submitted

March 5, 2024

First Submitted That Met QC Criteria

March 10, 2024

First Posted (Actual)

March 15, 2024

Study Record Updates

Last Update Posted (Actual)

August 22, 2024

Last Update Submitted That Met QC Criteria

August 20, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GR2102-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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