A Study to Evaluate the Safety of GR2301 Injection in Healthy Volunteers.

NCT07190716 | Not Yet Recruiting Phase 1

• 1 other identifier: GR2301-001
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, double-blind, placebo-controlled Phase I clinical trial evaluating the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary pharmacodynamic characteristics of GR2301 injection in healthy adult subjects in China.The GR2301 injection dosage will be gradually increased. All healthy subjects will receive a single subcutaneous injection. Following administration, subjects will be followed for at least 16 weeks ± 7 days.

Conditions

Single Ascending Dose; Healthy Subjects

Outcome Measures

Primary Outcomes (1)

• Adverse events (AEs)

  Incidence of AEs

  up to week16

Secondary Outcomes (2)

• Pharmacokinetics parameters

  up to week16

• Incidence of ADA.

  up to week16

Study Arms (5)

GR2301 injection 1

EXPERIMENTAL

GR2301 injection dose 1/Placebo，Subcutaneous

Biological: GR2301 injection

GR2301 injection 2

EXPERIMENTAL

GR2301 injection dose 2/Placebo，Subcutaneous

Biological: GR2301 injection

GR2301 injection 3

EXPERIMENTAL

GR2301 injection dose 3/Placebo，Subcutaneous

Biological: GR2301 injection

GR2301 injection 4

EXPERIMENTAL

GR2301 injection dose 4/Placebo，Subcutaneous

Biological: GR2301 injection

GR2301 injection 5

EXPERIMENTAL

GR2301 injection dose 5/Placebo，Subcutaneous

Biological: GR2301 injection

Interventions

GR2301 injection BIOLOGICAL

IL15 monoclonal antibody

GR2301 injection 1; GR2301 injection 2; GR2301 injection 3; GR2301 injection 4; GR2301 injection 5

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI 19.0-28.0 kg/m², with male subjects weighing ≥50.0 kg and female subjects weighing ≥45.0 kg；
• Understand and comply with the requirements of the clinical protocol, voluntarily participate in the clinical trial, and sign the informed consent form.

You may not qualify if:

• A history of past or current conditions involving the nervous system, cardiovascular system, urinary system, digestive system, respiratory system, endocrine system, metabolic system, or other clearly documented medical conditions, which the investigator deems may pose a risk to the subject's safety or interfere with the conduct, progress, or completion of the trial.
• History of drug use or substance abuse, or positive urine drug screening prior to enrollment.
• Pregnant and breastfeeding women.

Sponsors & Collaborators

• Genrix (Shanghai) Biopharmaceutical Co., Ltd.: lead

Study Sites (1)

Beijing Tongren Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, China

Location

Central Study Contacts

liaison officer

CONTACT

18233161126; shuxueye@genrixbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: September 24, 2025
• Study Start: October 10, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: September 24, 2025

Record last verified: 2025-09

Locations

CN (1)