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

Respiratory Syncytial Virus Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06313697
• Other study ID #: GR2102-001
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: March 24, 2024
• Est. completion date: December 6, 2025

Study information

• Verified date: March 2024
• Source: Genrix (Shanghai) Biopharmaceutical Co., Ltd.
• Contact: wei zhao, PHD
• Phone: 15131190710
• Email: zhao4wei[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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。

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 132
• Est. completion date: December 6, 2025
• Est. primary completion date: January 6, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Syncytial Virus Infections

Intervention

Biological:
• GR2102 injection
single dose
• placebo
single dose

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Shandong First Medical University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Genrix (Shanghai) Biopharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Maximum Observed Serum Concentration	Pharmacokinetic indices	150 days post dose
Secondary	Terminal Elimination Half Life	Pharmacokinetic indices	150 days post dose
Secondary	anti-respiratory syncytial virus neutralizing antibodies titer levels	indicator of immunogenicity	150 days post dose