Health TrialsbyHealthPanel

A Study to Evaluate the Safety, Immunogenicity, and Pharmacokinetics of GR2303 in Healthy Adult

ConditionHealth Adult Subjects
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorGenrix (Shanghai) Biopharmaceutical Co., Ltd.

About this trial

he goal this clinical trail is to evaluate the safety、Pharmacokinetic and immunogenicity of GR2303 injection。 Subjects will be enrolled in different groups in sequential order, and within each group will be randomly assigned to receive either GR2303 injection or placebo administration, with each Subjects will be enrolled in only one of these groups

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy adult subjects

Signed informed consent

Disqualifiers

History or presence of any clinically significant organ system disease that could interfere with the objectives of the study or the safety of the subjects.

Prior use of drug targeting TNF-like cytokine 1A

history of malignant tumor

psitive results for Hepatitis B surface antigen (HBsAg), anti Hepatitis C antibody (HCV Ab) or human immunodeficiency virus (HIV)

Trial design

Design model

Sequential

Treatments tested in this trial

  • GR2303 injection

    Biological/Vaccine

    single dose

  • Placebo

    Biological/Vaccine

    single dose

  • GR2303 injection

    Biological/Vaccine

    multiple dose

  • Placebo

    Biological/Vaccine

    multiple dose

Treatment groups

64 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: group 1Experimental treatment 2 interventions
Group B: group 2Experimental treatment 2 interventions
Group C: group 3Experimental treatment 2 interventions
Group D: group 4Experimental treatment 2 interventions
Group E: group 5Experimental treatment 2 interventions
Group F: group 6Experimental treatment 2 interventions
Group G: group 7Experimental treatment 2 interventions
Group H: group 8Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Adverse events

Time frame
16 weeks

Secondary outcomes

1

Cmax

Time frame
16 weeks
2

Tmax

Time frame
16 weeks
3

t 1/2

Time frame
16 weeks
4

ADA

Time frame
16 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Genrix (Shanghai) Biopharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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