A Clinical Study of GZR33 and GZR101 in Healthy Subjects

NCT06556641 | Completed Phase 1

• 1 other identifier: GL-GZR-CH1013
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• AUC0-24h

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

  From 0 to 24 hours

• Incidence of adverse events (AE)

  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.

  From Predose to Day12

Secondary Outcomes (3)

• Cmax

  From Predose to Day7

• tmax

  From Predose to Day7

• AUC0-last

  From Predose to Day7

Study Arms (2)

Part A

EXPERIMENTAL

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

Drug: GZR33 Injection; Drug: Insulin Degludec

Part B

EXPERIMENTAL

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.

Drug: GZR33 Injection; Drug: GZR101 Injection; Drug: Placebo

Interventions

GZR33 Injection DRUG

Administered as once daily subcutaneous dose

Part A; Part B

GZR101 Injection DRUG

Administered as once daily subcutaneous dose

Part B

Placebo DRUG

Administered as once daily subcutaneous dose

Part B

Insulin Degludec DRUG

Administered as once daily subcutaneous dose

Part A

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. Voluntarily participated in the study and signed the informed consent form (ICF);
• Chinese healthy male adult subjects aged 18-45 years old (including 18 and 45 years old as of the date of signing the ICF);
• 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).

You may not qualify if:

• History of drug abuse within one year prior to screening.
• 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.
• 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.
• Hepatitis B surface antigen (HBsAg), hepatitis C antibodies, syphilis spiral test or human immunodeficiency virus (HIV) antibodies positive.
• History of needle and blood sickness, and subject couldn't tolerate venipuncture for blood collection, or be difficult to collect blood.

Sponsors & Collaborators

• Gan and Lee Pharmaceuticals, USA: lead

Study Sites (1)

Study Site

Xingtai, Hebei, China

Location

MeSH Terms

Interventions

insulin degludec

Study Officials

• Clinical Transparency

  Gan & Lee Pharmaceuticals.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 16, 2024
• Study Start: December 17, 2022
• Primary Completion: February 3, 2023
• Study Completion: February 3, 2023
• Last Updated: August 16, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)