GZR18 Injection for Obesity and Type 2 Diabetes

Bioequivalence Study of GZR18 Injection Before and After CMC Change

Recruiting Phase 1 Interventional Study
Obesity&T2D
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 50
Sex
Male
Trial phase
Phase 1
Study type
Interventional
Purpose
Other
Participants needed
138 (estimated)
Sponsor
Gan & Lee Pharmaceuticals. · Industry
Who this trial is looking for

This trial is looking for healthy adult males aged 18 to 50 to test a medication called GZR18 Injection. Participants will receive a single dose and will be monitored for safety and drug levels over 35 days.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am male and between 18 and 50 years old.
  • I weigh at least 50 kg.
  • My body mass index (BMI) is between 19 and 26.
  • I can provide informed consent.
  • I do not plan to father a child during the study.
  • I understand the study details and agree to follow the rules.

You may not be able to join if

  • I have significant health issues found during screening.
  • I tested positive for hepatitis B, hepatitis C, or HIV.
  • I have a history of serious medical or psychiatric disorders.
  • I have had pancreatitis or pancreatic injury.
  • I have a family history of medullary thyroid carcinoma.
  • I have taken certain medications that affect drug metabolism recently.
  • I have had major surgery in the past 6 months.
  • I have smoked more than 5 cigarettes daily in the last 3 months.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
This is an open-label, randomized, single-dose, parallel comparison bioequivalence study conducted in healthy adult male subjects. The study is divided into 3 parts, each of which evaluates the bioequivalence of GZR18 Injection for one strength before and after CMC changes. Subjects eligible for each part of the screening will be randomized into Group A or Group B in a 1:1 ratio. Each subject wi…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Subjects who voluntarily sign the Informed Consent Form (ICF), can receive SC injection, fully understand the content, process and possible adverse reactions of the trial, and are able to follow the regulations on contraindications and restrictions specified in this protocol.…
Contacts

Xin Zhang Xin Zhang

010-56456739

xin5.zhang@ganlee.com

CONTACT