NCT06548906 A Study of GZR4 Injection at Different Injection Sites
| NCT ID | NCT06548906 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Gan and Lee Pharmaceuticals, USA |
| Condition | Healthy Subjects |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2024-05-08 |
| Primary Completion | 2024-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 24 participants in total. It began in 2024-05-08 with a primary completion date of 2024-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 5\. More than 14 units of alcohol per week within 3 months prior to randomization * 6\. Smoking more than 5 cigarettes per day within 3 months prior to randomization
Contact & Investigator
Clinical Transparency
STUDY DIRECTOR
Gan & Lee Pharmaceuticals.
Frequently Asked Questions
Who can join the NCT06548906 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 55 Years, studying Healthy Subjects. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06548906 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06548906 currently recruiting?
Yes, NCT06548906 is actively recruiting participants. Contact the research team at wei.zhao@ganlee.com for enrollment information.
Where is the NCT06548906 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06548906 clinical trial?
NCT06548906 is sponsored by Gan and Lee Pharmaceuticals, USA. The principal investigator is Clinical Transparency at Gan & Lee Pharmaceuticals.. The trial plans to enroll 24 participants.