Actively Recruiting
A Trial Investigating the Pharmacokinetics, Pharmacodynamics and Safety of GZR4 Injection at Different Injection Regions in Healthy Subjects
Led by Gan and Lee Pharmaceuticals, USA · Updated on 2024-08-12
24
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the pharmacokinetics (PK), pharmacodynamics (PD), and safety of GZR4 Injection in healthy adult male volunteers aged 18 to 55 years. The study is a randomized, single-center, open, three-period crossover trial conducted in China, designed to compare the effects of a single dose of GZR4 when injected into different body sites. This phase 1 trial aims to understand how the drug behaves and acts in the body depending on the injection region. Participants will receive a single subcutaneous injection of GZR4 at one of three sites: the abdomen, the deltoid region of the upper arm, or the thigh. Each participant will undergo all three injection site treatments in a crossover manner, allowing direct comparison of the drug’s absorption and activity from these locations. The dosing schedule includes one injection per study period, with careful monitoring following each administration. During the study, participants will be closely observed with physical exams, vital signs, laboratory tests, imaging, and electrocardiograms to track safety and drug effects. Researchers will measure key outcomes such as drug exposure over time (AUC0-672h), maximum concentration (Cmax), and other pharmacodynamic markers. The total participation duration covers the study treatments and follow-up assessments extending up to 672 hours after each dose to ensure comprehensive data collection and safety monitoring.
CONDITIONS
Brief Title
A Study of GZR4 Injection at Different Injection Sites
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form and able to comply with the study protocol
- Male adults aged 18 to 55 years
- Body mass index (BMI) between 19.0 and 24.0 kg/m2
You will not qualify if you...
- Known or suspected allergy to the investigational drug or related products
- Participation in another clinical drug study within 3 months before randomization
- Abnormal clinical findings in physical exam, vital signs, labs, imaging, or ECG at screening
- Blood donation over 100 mL or significant blood loss above 200 mL within 6 months prior to screening
- Consumption of more than 14 units of alcohol per week within 3 months before randomization
- Smoking more than 5 cigarettes per day within 3 months before randomization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Each injection period lasts up to 672 hours after a single dose
Participants receive GZR4 Injection by subcutaneous injection once weekly at different injection sites including abdomen, upper arm, and thigh in a crossover design.
1 visit per injection site (in-person)
Trial Site Locations
Total: 1 location
1
Study Site
Beijing, China
Actively Recruiting
Research Team
W
wei zhao, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here