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NCT07918898
Comparison of Pharmacokinetic/Pharmacodynamic Characteristics and Safety of GZR101-80 Injection With Separately Injected, Simultaneous Doses of GZR33 Injection and Insulin Aspart
Conditions: Healthy Participants
Sex: Male
Ages: 18 Years – 45 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 26
Sponsor: Gan & Lee Pharmaceuticals.
Summary
This trial is conducted in China. This study will be conducted to evaluate pharmacokinetic/pharmacodynamic characteristics and safety of single administration of GZR101-80 Injection with separately injected, simultaneous doses of GZR33 Injection and Insulin Aspart in healthy participants
Eligibility Criteria
Inclusion Criteria:
1. Voluntarily signed the informed consent form (ICF), was amenable to subcutaneous injection, had fully understood the study content, procedures and potential adverse reactions, and was able to comply with the contraindications and restrictions specified in this protocol.
2. Male, aged between 18 and 45 years (both inclusive) at the time of ICF.
Exclusion Criteria:
1. Subjects with allergic diathesis, or a medical history of allergic diseases such as bronchial asthma and eczema.
2. Subjects with abnormal findings for hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus antigen and antibody combined assay, or treponema pallidum antibody test at screening.
3. Subjects who donated blood or had blood loss of ≥ 400 mL within 6 months prior to screening, or intend to donate blood during the study.
4. Subjects with a history of drug abuse prior to screening, or with a positive drug abuse screening result at screening.
5. Subjects with an average daily cigarette consumption of ≥5 cigarettes within 3 months prior to screening, or those who refuse to abstain from smoking throughout the study period.
6. Subjects with a history of vasovagal syncope related to needles or blood, difficulty in blood collection, or intolerance to venipuncture for blood sampling.
7. Subjects who are employees of the investigator or the study site, or family members of such employees or investigators, or subjects whom the investigator considers otherwise unsuitable for participation in this study.
Source: ClinicalTrials.gov (NCT07918898). StuddyBuddy aggregates publicly available trial information.