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Completed

NCT Number: NCT06548932

A Study to Evaluate the Safety, Tolerance, PK and PD Parameters of GZR33 and GZR101 in Healthy Male Adult Subjects

This is a randomized, double-blind, placebo-controlled, single dose phase I clinical study. It is divided into two parts: part A , a single ascending dose assessment of GZR33, and partB, a single dose evaluation of GZR101.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Study Site 01

Tianjin, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 1. Voluntarily participated in the study and signed the informed consent form (ICF);
  • 2. Chinese healthy male adult subjects, aged 18-45 years old (both inclusive) at the time of signing the ICF;
  • 3.Body mass index [BMI= weight (kg)/height (m) 2] at screening between 19.0 and 24.0 kg/m2, inclusive, a body weight ≥50 kg;

Exclusion criteria

  • 1. Abnormalities assessed by the investigator to be clinically significant while screening: vital signs, physical examination, laboratory examination, anterior and lateral chest X-ray and 12-lead ECG;
  • 2. Known severe allergy (such as allergy to more than 3 allergens, allergic asthma affecting the lower respiratory tract, and allergy requiring glucocorticoid treatment) or known history of allergy to the drug ingredients used in this study;
  • 3. Participants who have smoked more than 5 cigarettes per day within 3 months before screening, smoked within 48 h before using the investigational drug, or impossibly stopped using any tobacco products during the test;
  • 4.History of drug abuse or drug abuse before screening, or positive results in alcohol testing and urine drug screening (morphine, methamphetamine, methadone, phencycldine piperidine, tetrahydrocannabinol acid, cocaine) while screening;
  • 5. Human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or treponema pallidum antibody positive.

Treatment and study plan

GZR33 Injection

Drug

A single dose

GZR101 Injection

Drug

A single dose

Placebo

Drug

A single dose

Primary outcomes

  1. Incidence of adverse events (AE)

    Time frame: From Predose to Day14 after a single dose

    Any changes or abnormal results in the following safety variables: incidence of adverse events (AE), including but not limited to hypoglycemic reactions, injection site reactions, clinical laboratory tests, 12-lead ECG, vital signs, physical examination, and local tolerability at the injection site.

Secondary outcomes

  1. GIRmax

    Time frame: From 0 hours to 24 hours after a single dose

    Maximum glucose infusion rate

  2. AUCGZR33,0-24 h

    Time frame: From Predose to Day8 after a single dose

    Area under the plasma concentration curve of GZR33 from 0 to 24 hours

  3. AUCIAsp,0-12 h

    Time frame: From 0 hours to 12 hours after a single dose

    Area under the plasma concentration curve of insulin aspart from 0 to 12 hours

Sponsors and collaborators

Lead sponsor

Gan and Lee Pharmaceuticals, USA

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerance, PK and PD Parameters of Single Dose Escalation of GZR33 and Single Administration of GZR101 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 16, 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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