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Completed

NCT Number: NCT06556641

A Clinical Study of GZR33 and GZR101 in Healthy Subjects

This study evaluates the safety, tolerability, pharmacokinetics, and pharmacodynamics of GZR33 and GZR101 in healthy adult male subjects.This study consists of Part A and Part B.

Part A is a randomized, open-label, single-dose, two-sequence, two-period, cross-over design comparative study evaluating the PD and PK characteristics of GZR33 and Insulin Degludec Injection.

Part B is a randomized, double-blind, placebo-controlled, multiple-dose, parallel-group design study evaluating the safety, tolerability, immunogenicity, and PK of GZR33 and 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

Xingtai, Hebei, 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 (including 18 and 45 years old as of the date of signing the ICF);
  • 3.During screening period, the body mass index (BMI) between 19.0 and 24.0 kg/m2, inclusive, and a body weight>50 kg (not containing 50kg).

Exclusion criteria

  • 1.History of drug abuse within one year prior to screening.
  • 2.History of alcohol abuse within 6 months prior to screening (alcohol abuse is defined as more than 14 units weekly: 1 unit of alcohol equals to 360 mL of beer, 150 mL of wine, or 45 mL of 40% alcohol).The subject who smoke more than 5 cigarettes per day within 3 months prior to screening, smoke within 48 h prior to the use of the investigational drug, and is unwilling to refrain from smoking and drinking during the trial period.
  • 3.Allergic constitution, or history of bronchial asthma, hives, eczema and other allergic diseases (except mild asymptomatic seasonal allergy), or known allergy to the investigational drug or its excipients, hypersensitivity or intolerance.
  • 4.Hepatitis B surface antigen (HBsAg), hepatitis C antibodies, syphilis spiral test or human immunodeficiency virus (HIV) antibodies positive.
  • 5.History of needle and blood sickness, and subject couldn't tolerate venipuncture for blood collection, or be difficult to collect blood.

Treatment and study plan

GZR33 Injection

Drug

Administered as once daily subcutaneous dose

GZR101 Injection

Drug

Administered as once daily subcutaneous dose

Placebo

Drug

Administered as once daily subcutaneous dose

insulin degludec

Drug

Administered as once daily subcutaneous dose

Primary outcomes

  1. AUC0-24h

    Time frame: From 0 to 24 hours

    Area under the plasma concentration-time curve from time 0 to 24 hours

  2. Incidence of adverse events (AE)

    Time frame: From Predose to Day12

    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. Cmax

    Time frame: From Predose to Day7

    Maximum plasma concentration

  2. tmax

    Time frame: From Predose to Day7

    Time to reach maximum plasma concentration

  3. AUC0-last

    Time frame: From Predose to Day7

    Area under the plasma concentration-time curve from time 0 to the last blood sampling time point

Sponsors and collaborators

Lead sponsor

Gan and Lee Pharmaceuticals, USA

Industry

Registry information

Official study title

Phase Ib Clinical Study on the Safety, Tolerance, Pharmacokinetics, and Pharmacodynamics of GZR33 and GZR101 in Healthy Adult Male Subjects

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 16, 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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