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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06548815

Enrollment

Registered

2024-08-12

Start date

2022-08-29

Completion date

2023-03-24

Last updated

2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Keywords

GZR4, PK

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.

Interventions

DRUGGZR4

Ascending single doses - 4 dose levels.

DRUGPlacebo

Ascending single doses - 4 dose levels.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* 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%

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame
Incidence of TEAE	Baseline to Day29

Secondary

Measure	Time frame
GIRmax	Day2-Day3
Tmax,GIR	Day2-Day3
AUCGIR	Day2-Day3/Day7-Day8
Cmax	Baseline to Day29
Tmax,GZR4	Baseline to Day29
T1/2	Baseline to Day29
AUC0-inf	Baseline to Day29
AUC0-last	Baseline to Day29

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026