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

Phase 1

Recruiting

• Conditions: Respiratory Syncytial Virus Infections
• Interventions: Biological: GR2102 injection; Biological: placebo

• Registration Number: NCT06313697
• Lead Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd.

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。

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 Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-05
• Study First Submitted QC: 2024-03-10
• Study First Posted: 2024-03-15
• Study Start: 2024-03-23
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-22
• Primary Completion: 2025-01-06
• Study Completion: 2025-12-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 132

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group 3	GR2102 injection	single dose
Treatment group 3	placebo	single dose
Treatment group 4	GR2102 injection	single dose
Treatment group 1	GR2102 injection	single dose
Treatment group 1	placebo	single dose
Treatment group 5	GR2102 injection	single dose
Treatment group 2	GR2102 injection	single dose
Treatment group 2	placebo	single dose
Treatment group 5	placebo	single dose
Treatment group 6	GR2102 injection	single dose
Treatment group 4	placebo	single dose
Treatment group 6	placebo	single dose

Primary Outcome Measures

Name	Time	Method
Adverse events	150 days post dose	to characterise the safety and tolerability of GR2102,including abnormal vital signs,laboratory tests,electrocardiogram and physical examination

Secondary Outcome Measures

Name	Time	Method
Maximum Observed Serum Concentration	150 days post dose	Pharmacokinetic indices
Terminal Elimination Half Life	150 days post dose	Pharmacokinetic indices
anti-respiratory syncytial virus neutralizing antibodies titer levels	150 days post dose	indicator of immunogenicity

Trial Locations

Locations (1)

The First Affiliated Hospital of Shandong First Medical University; 🇨🇳 Jinan, Shandong, China