Status:
COMPLETED
A Study to Evaluate the Safety, Tolerance, PK and PD Parameters of GZR33 and GZR101 in Healthy Male Adult Subjects
Lead Sponsor:
Gan and Lee Pharmaceuticals, USA
Conditions:
Healthy Subjects
Eligibility:
MALE
18-45 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 1\. Voluntarily participated in the study and signed the informed consent form (ICF);
- 2\. Chinese healthy male adult subjects, aged 18-45 years old (both inclusive) at the time of signing the ICF;
- 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
- 1\. 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;
- 2\. 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;
- 3\. 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;
- 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;
- 5\. Human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or treponema pallidum antibody positive.
Key Trial Info
Start Date :
June 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 24 2023
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT06548932
Start Date
June 30 2022
End Date
February 24 2023
Last Update
August 16 2024
Active Locations (1)
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1
Study Site 01
Tianjin, China