A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerance, PK and PD Parameters of Single Dose Escalation of GZR33 and Single Administration of GZR101 in Healthy Male Adult Subjects
Overview
- Phase
- Phase 1
- Intervention
- GZR33 Injection
- Conditions
- Healthy Subjects
- Sponsor
- Gan and Lee Pharmaceuticals, USA
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- Incidence of adverse events (AE)
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This is a randomized, double-blind, placebo-controlled, single dose phase I clinical study. It is divided into two parts: part A , a single ascending dose assessment of GZR33, and partB, a single dose evaluation of GZR101.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Voluntarily participated in the study and signed the informed consent form (ICF);
- •Chinese healthy male adult subjects, aged 18-45 years old (both inclusive) at the time of signing the ICF;
- •3.Body mass index \[BMI= weight (kg)/height (m) 2\] at screening between 19.0 and 24.0 kg/m2, inclusive, a body weight ≥50 kg；
Exclusion Criteria
- •Abnormalities assessed by the investigator to be clinically significant while screening: vital signs, physical examination, laboratory examination, anterior and lateral chest X-ray and 12-lead ECG;
- •Known severe allergy (such as allergy to more than 3 allergens, allergic asthma affecting the lower respiratory tract, and allergy requiring glucocorticoid treatment) or known history of allergy to the drug ingredients used in this study;
- •Participants who have smoked more than 5 cigarettes per day within 3 months before screening, smoked within 48 h before using the investigational drug, or impossibly stopped using any tobacco products during the test;
- •4.History of drug abuse or drug abuse before screening, or positive results in alcohol testing and urine drug screening (morphine, methamphetamine, methadone, phencycldine piperidine, tetrahydrocannabinol acid, cocaine) while screening;
- •Human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or treponema pallidum antibody positive.
Arms & Interventions
GZR33 Injection
Participants will receive GZR33 Injection or placebo, s.c. a single dose (Part A)
Intervention: GZR33 Injection
GZR33 Injection
Participants will receive GZR33 Injection or placebo, s.c. a single dose (Part A)
Intervention: Placebo
GZR101 Injection
Participants will receive GZR101 Injection or placebo, s.c. a single dose (Part B)
Intervention: GZR101 Injection
GZR101 Injection
Participants will receive GZR101 Injection or placebo, s.c. a single dose (Part B)
Intervention: Placebo
Outcomes
Primary Outcomes
Incidence of adverse events (AE)
Time Frame: From Predose to Day14 after a single dose
Any changes or abnormal results in the following safety variables: incidence of adverse events (AE), including but not limited to hypoglycemic reactions, injection site reactions, clinical laboratory tests, 12-lead ECG, vital signs, physical examination, and local tolerability at the injection site.
Secondary Outcomes
- AUCIAsp，0-12 h(From 0 hours to 12 hours after a single dose)
- GIRmax(From 0 hours to 24 hours after a single dose)
- AUCGZR33,0-24 h(From Predose to Day8 after a single dose)