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Completed

NCT Number: NCT06548815

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single-dose GZR4

This trial is conducted in China. The aim of this trial is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single-dose GZR4.

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Key information

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Gan & Lee Pharmaceuticals Co., Ltd

Beijing, Beijing Municipality, 100000, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GZR4

Drug

Ascending single doses - 4 dose levels.

Placebo

Drug

Ascending single doses - 4 dose levels.

Primary outcomes

  1. Incidence of TEAE

    Time frame: Baseline to Day29

Secondary outcomes

  1. GIRmax

    Time frame: Day2-Day3

  2. Tmax,GIR

    Time frame: Day2-Day3

  3. AUCGIR

    Time frame: Day2-Day3/Day7-Day8

  4. Cmax

    Time frame: Baseline to Day29

  5. Tmax,GZR4

    Time frame: Baseline to Day29

  6. T1/2

    Time frame: Baseline to Day29

  7. AUC0-inf

    Time frame: Baseline to Day29

  8. AUC0-last

    Time frame: Baseline to Day29

Sponsors and collaborators

Lead sponsor

Gan and Lee Pharmaceuticals, USA

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 12, 2024
Registry last updated
Aug 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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