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A Study of GZR4 Injection at Different Injection Sites

ConditionHealthy Subjects
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-55
SponsorGan and Lee Pharmaceuticals, USA

About this trial

This trial is conducted in China. This study is a randomized, single-center, open, three-period crossover trial in healthy subjects to compare the PK, PD, and safety of a single administration of GZR4 at different injection sites (abdomen, deltoid region of upper arm, and thigh).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

1. Signing the informed consent form (ICF) before the trial, fully understanding the trial content, process and possible adverse reactions, and being able to comply with the contraindications and restrictions specified in this protocol.

2. A Male adult subjects aged 18-55 years old.

3. Body mass index (BMI) between 19.0-24.0 kg/m2

Disqualifiers

1. Known or suspected hypersensitivity to investigational medical product(s) or related products.

2. Participation in a clinical study of another study drug within 3 months prior to randomization.

3. Physical examination, vital signs, laboratory examination, imaging examination, 12-lead electrocardiogram and other auxiliary examination results that the researchers considered abnormal clinical significance during screening.

4. Donation of blood or blood products (more than 100mL) or significant blood loss (more than 200 mL) within 6 months prior to screening

Trial design

Design model

Crossover

Treatments tested in this trial

  • GZR4 Injection

    Drug

    GZR4 Injection administered sc, once weekly.

Treatment groups

24 Participants
are divided into 3 treatment groups
Group A: GZR4 Injection- AbdomenExperimental treatment 1 intervention
Group B: GZR4 Injection- Upper ArmExperimental treatment 1 intervention
Group C: GZR4 Injection- ThighExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

AUC0-672h

Area Under the Concentration Versus Time Curve of GZR4 Injection From Time Zero to 672 hours

Time frame
From Predose to 672 hours after a single dose

Secondary outcomes

1

AUC0-∞

Area Under the Concentration Versus Time Curve of GZR4 Injection From Time Zero to Infinity

Time frame
From Predose to 672 hours after a single dose
2

Cmax

Maximum Concentration of GZR4 Injection

Time frame
From Predose to 672 hours after a single dose

Other outcomes

Sponsors and contacts

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

Gan and Lee Pharmaceuticals, USA

Lead sponsor

Source ClinicalTrials.gov
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