Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single-dose GZR4
NCT ID: NCT06548815
Last Updated: 2024-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
43 participants
INTERVENTIONAL
2022-08-29
2023-03-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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GZR4
s.c, single dose
GZR4
Ascending single doses - 4 dose levels.
Placebo
s.c, single dose
Placebo
Ascending single doses - 4 dose levels.
Interventions
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GZR4
Ascending single doses - 4 dose levels.
Placebo
Ascending single doses - 4 dose levels.
Eligibility Criteria
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Inclusion Criteria
* Body mass index \[BMI between 19.0-24.0 kg/m2
* Hemoglobin A1c (HbA1c)≤6%
Exclusion Criteria
* Known severe allergies (e.g., allergy to more than 3 allergens, allergic asthma affecting the lower respiratory tract, allergy requiring glucocorticoid treatment) or known allergic history to the ingredients of the investigational drug used in this study
* Participants had donated blood ≥ 200 mL within 6 months before screening, or had donated blood components, or had a total blood loss of ≥ 200 mL due to any reason, or history of blood transfusion or use of blood products
* Human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or treponema pallidum antibody positive
* Participated in other clinical trials and used investigational drugs or medical devices within 3 months before screening
18 Years
45 Years
MALE
Yes
Sponsors
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Gan and Lee Pharmaceuticals, USA
INDUSTRY
Responsible Party
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Locations
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Gan & Lee Pharmaceuticals Co., Ltd
Beijing, Beijing Municipality, China
Countries
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Other Identifiers
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GL-GZR-CH1004
Identifier Type: -
Identifier Source: org_study_id
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