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
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
Treatments tested in this trial
- GZR4 Injection
Treatment groups
24 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov