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

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

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06313697

Enrollment

132

Registered

2024-03-15

Start date

2024-03-23

Completion date

2025-12-06

Last updated

2024-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Syncytial Virus Infections

Keywords

respiratory syncytial virus, RSV, respiratory infection

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.

Interventions

BIOLOGICALGR2102 injection

single dose

BIOLOGICALplacebo

single dose

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

China

Contacts

Primary Contactwei zhao, PHD

zhao4wei@hotmail.com15131190710

Backup Contactjuan huang, MD

huangjuan@genrixbio.com19301494061

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026