Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single-dose GZR4
A Single-center, Single-administration, Randomized, Placebo-controlled, Dose-escalation Trial Evaluated the Safety, Tolerability, PK, and PD Parameters of GZR4 in Healthy Male Adult Subjects
1 other identifier
interventional
43
1 country
1
Brief Summary
This trial is conducted in China. The aim of this trial is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single-dose GZR4.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 diabetes
Started Aug 2022
Typical duration for phase_1 diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 29, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 24, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 24, 2023
CompletedFirst Submitted
Initial submission to the registry
August 5, 2024
CompletedFirst Posted
Study publicly available on registry
August 12, 2024
CompletedAugust 12, 2024
August 1, 2024
7 months
August 5, 2024
August 7, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of TEAE
Baseline to Day29
Secondary Outcomes (8)
GIRmax
Day2-Day3
Tmax,GIR
Day2-Day3
AUCGIR
Day2-Day3/Day7-Day8
Cmax
Baseline to Day29
Tmax,GZR4
Baseline to Day29
- +3 more secondary outcomes
Study Arms (2)
GZR4
EXPERIMENTALs.c, single dose
Placebo
PLACEBO COMPARATORs.c, single dose
Interventions
Eligibility Criteria
You may qualify if:
- Chinese healthy male adult subjects aged 18-45 years old
- Body mass index \[BMI between 19.0-24.0 kg/m2
- Hemoglobin A1c (HbA1c)≤6%
You may not qualify if:
- Abnormalities that were assessed by the investigators to be clinically significant at screening included vital signs, physical examination, laboratory testing, anteroposterior and lateral chest radiography, and 12-lead ECG
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gan & Lee Pharmaceuticals Co., Ltd
Beijing, Beijing Municipality, 100000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2024
First Posted
August 12, 2024
Study Start
August 29, 2022
Primary Completion
March 24, 2023
Study Completion
March 24, 2023
Last Updated
August 12, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share