A Clinical Trial of Multiple Doses of GR2301 Injection in Healthy Adult Trial Participants in China.

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorGenrix (Shanghai) Biopharmaceutical Co., Ltd.

About this trial

This is a randomized, double-blind, placebo-controlled Phase I clinical trial evaluating the safety, tolerability, pharmacokinetics and immunogenicity characteristics of GR2301 injection in healthy adult subjects in China. The Multiple doses will be gradually escalated.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • GR2301 injection

    Drug

    IL15 monoclonal antibody

Treatment groups

36 Participants
are divided into 3 treatment groups
Group A: GR2301 injection dose1/PlaceboExperimental treatment 1 intervention
Group B: GR2301 injection dose2/PlaceboExperimental treatment 1 intervention
Group C: GR2301 injection dose3/PlaceboExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Adverse events (AEs)

Incidence of AEs

Time frame
Up to 52 Weeks

Secondary outcomes

1

Pharmacokinetics parameters

concentration of GR2301

Time frame
Up to 52 weeks
2

Incidence of ADA.

Time frame
Up to 52 weeks

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: