A Clinical Study of GZR33 and GZR101 in Healthy Subjects

NCT ID: NCT06556641

Last Updated: 2024-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-17
• Study Completion Date: 2023-02-03

Brief Summary

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.

Conditions

Healthy Subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Part A

Part A : randomized, open-label, single-dose, two-sequence, two-period, cross-over

Single administration of GZR33, washout period of 14 days, followed by single administration of Insulin Degludec

Single administration of Insulin Degludec, washout period of 14 days, followed by single administration of GZR33

Group Type: EXPERIMENTAL

GZR33 Injection

Intervention Type: DRUG

Administered as once daily subcutaneous dose

Insulin Degludec

Intervention Type: DRUG

Administered as once daily subcutaneous dose

Part B

Part B: randomized, double-blind, placebo-controlled, multiple-dose, parallel

Drug: GZR33 Injection Participants will receive once daily GZR33 Injection or placebo for 6 days, s.c.

Drug: GZR101 Injection Participants will receive once daily GZR101 Injection or placebo for 6 days, s.c.

Group Type: EXPERIMENTAL

GZR33 Injection

Intervention Type: DRUG

Administered as once daily subcutaneous dose

GZR101 Injection

Intervention Type: DRUG

Administered as once daily subcutaneous dose

Placebo

Intervention Type: DRUG

Administered as once daily subcutaneous dose

Interventions

GZR33 Injection

Administered as once daily subcutaneous dose

Intervention Type: DRUG

GZR101 Injection

Administered as once daily subcutaneous dose

Intervention Type: DRUG

Placebo

Administered as once daily subcutaneous dose

Intervention Type: DRUG

Insulin Degludec

Administered as once daily subcutaneous dose

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Gan and Lee Pharmaceuticals, USA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Transparency

Role: STUDY_DIRECTOR

Gan & Lee Pharmaceuticals.

Locations

Study Site

Xingtai, Hebei, China

Countries

China

Other Identifiers

GL-GZR-CH1013

Identifier Type: -

Identifier Source: org_study_id