Status:
COMPLETED
A Clinical Study of GZR33 and GZR101 in Healthy Subjects
Lead Sponsor:
Gan and Lee Pharmaceuticals, USA
Conditions:
Healthy Subjects
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
This study evaluates the safety, tolerability, pharmacokinetics, and pharmacodynamics of GZR33 and GZR101 in healthy adult male subjects.This study consists of Part A and Part B. Part A is a randomiz...
Eligibility Criteria
Inclusion
- 1\. Voluntarily participated in the study and signed the informed consent form (ICF);
- Chinese healthy male adult subjects aged 18-45 years old (including 18 and 45 years old as of the date of signing the ICF);
- During screening period, the body mass index (BMI) between 19.0 and 24.0 kg/m2, inclusive, and a body weight\>50 kg (not containing 50kg).
Exclusion
- History of drug abuse within one year prior to screening.
- History of alcohol abuse within 6 months prior to screening (alcohol abuse is defined as more than 14 units weekly: 1 unit of alcohol equals to 360 mL of beer, 150 mL of wine, or 45 mL of 40% alcohol).The subject who smoke more than 5 cigarettes per day within 3 months prior to screening, smoke within 48 h prior to the use of the investigational drug, and is unwilling to refrain from smoking and drinking during the trial period.
- Allergic constitution, or history of bronchial asthma, hives, eczema and other allergic diseases (except mild asymptomatic seasonal allergy), or known allergy to the investigational drug or its excipients, hypersensitivity or intolerance.
- Hepatitis B surface antigen (HBsAg), hepatitis C antibodies, syphilis spiral test or human immunodeficiency virus (HIV) antibodies positive.
- History of needle and blood sickness, and subject couldn't tolerate venipuncture for blood collection, or be difficult to collect blood.
Key Trial Info
Start Date :
December 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 3 2023
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT06556641
Start Date
December 17 2022
End Date
February 3 2023
Last Update
August 16 2024
Active Locations (1)
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1
Study Site
Xingtai, Hebei, China