Comparative Clinical Trial of Pharmacokinetics and Pharmacodynamics of Human Insulin Injection

NCT07608692 | Completed Phase 1

• 1 other identifier: PD-INS-PK-PD355
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

A study of Clinical Trial Comparing Pharmacokinetics and Pharmacodynamics of Human Insulin Injection,in Wuhan Pulmonary Hospital (Wuhan Tuberculosis Prevention and Control Institute).To compare the pharmacokinetic and pharmacodynamics properties of a single subcutaneous dose of the human insulin injection (USLIN®R, Zhuhai United Laboratories (Zhongshan) Co., Ltd.) with the reference product (Novolin®R, Novo Nordisk Inc.) in healthy male subjects,and to evaluate the safety, tolerability, and immunogenicity of the test formulation versus the reference formulation in healthy male subjects.This single-center, randomized, double-blind, two-formulation, single-dose, two-period crossover study will enroll 32 healthy male subjects randomized 1:1 into two sequence groups (A/B, group A is administered in the sequence of T-R, while group B is in R-T). To evaluate the pharmacokinetic and pharmacodynamic properties of the test preparation and the control preparation in healthy male subjects. Each subject will receive single doses of both test and reference formulations across two periods (with ≥14-day washout), following the predefined sequence allocation table. After completing period 2 pharmacokinetic blood sampling, subjects will administer assigned insulin TID for two consecutive days to assess test-reference immunogenicity differences.

Conditions

Pharmacokinetics and Pharmacodynamics

Outcome Measures

Primary Outcomes (4)

• Primary PK Parameters (Peak Plasma Concentration (Cmax）)

  PK Parameters (Peak Plasma Concentration (Cmax）)

  0 to 12 hours

• Primary PK Parameters (Area under the plasma concentration-time curve from time 0 to time τ(AUC0-τ))

  Area under the plasma concentration-time curve from time 0 to time τ(AUC0-τ)

  0 to 12 hours

• Primary PD Parameters (Area under the glucose infusion rate curve from time 0 to time τ(AUCGIR0-τ))

  Area under the glucose infusion rate curve from time 0 to time τ(AUCGIR0-τ)

  0 to 12 hours

• Primary PD Parameters (Maximum glucose infusion rate (GIRmax))

  Maximum glucose infusion rate (GIRmax)

  0 to 12 hours

Secondary Outcomes (8)

• Secondary PK Parameters (Area under the plasma concentration-time curve from time 0 to time 2 hours(AUC0-2h))

  0 to 2 hours

• Secondary PK Parameters (Area under the plasma concentration-time curve from time 0 extrapolated to infinity(AUC0-∞))

  0 to 12 hours

• Secondary PK Parameters (Time to maximum (peak) plasma concentration(Tmax))

  0 to 12 hours

• Secondary PK Parameters (Terminal elimination rate constant(λz))

  0 to 12 hours

• Secondary PK Parameters (Elimination half-life(t1/2))

  0 to 12 hours

Other Outcomes (2)

• Immunogenicity Assessment (Anti-drug antibody (ADA) incidence (positive rate))

  0 to 12 hours

• Immunogenicity Assessment (ADA titers (for positive samples))

  0 to 12 hours

Study Arms (2)

Group A

EXPERIMENTAL

Drug: Human Insulin Injection（USLIN®R）; Drug: Human Insulin Injection（NOVOLIN®R）

Group B

ACTIVE COMPARATOR

Drug: Human Insulin Injection（USLIN®R）; Drug: Human Insulin Injection（NOVOLIN®R）

Interventions

Human Insulin Injection（USLIN®R） DRUG

a single subcutaneous dose of 0.3 IU/kg

Group A; Group B

Human Insulin Injection（NOVOLIN®R） DRUG

a single subcutaneous dose of 0.3 IU/kg

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 18 to 55 years old (inclusive of 18 and 55 years).
• Gender: Male.
• Body Weight: Not less than 55.0 kg for men, with a body mass index \[BMI = weight (kg) / height² (m²)\] between 18.0 and 29.0 kg/m² (inclusive of boundary values).
• Vital Signs: Systolic blood pressure ≥90 mmHg and \<140 mmHg, diastolic blood pressure ≥60 mmHg and \<90 mmHg, pulse rate ≥60 beats/min and ≤100 beats/min, body temperature (forehead) between 36.0°C and 37.3°C, with final judgment by the investigator.
• Glucose Tolerance: Normal glucose tolerance (fasting plasma glucose (FPG) \<6.10 mmol/L and \>3.50 mmol/L, and 2-hour postprandial blood glucose in oral glucose tolerance test (OGTT) \<140 mg/dL (7.78 mmol/L)), glycated hemoglobin value \<6.3% and \>4.5%.

You may not qualify if:

• Those who have participated in a clinical trial of another drug/device and used the investigational drug/device within 6 months.
• Those with a history of severe vomiting, diarrhea, or any other disease or condition that could interfere with trial results within 7 days prior to the trial.
• Those with a history of specific allergies (e.g., asthma, urticaria, eczema) or allergies to any medications, foods, or pollen, or known allergies to insulin.
• Those with positive anti-insulin antibodies.
• Those who have lost or donated more than 400 mL of blood, received blood transfusions, or used blood products within 3 months prior to the trial, or who plan to donate blood during the trial.
• Subjects with plans for childbearing or sperm donation from 2 weeks prior to the trial to 6 months after the last dose, and who are unwilling or unable to use effective contraception.
• Those with clinically significant abnormalities in general physical examination, laboratory tests (blood routine, blood biochemistry, coagulation function, urine routine, etc.) within 7 days prior to the trial, or electrocardiogram results deemed clinically significant by the clinician within 14 days prior to the trial.
• Those with one or more clinically significant positive results for hepatitis B, hepatitis C, HIV, or syphilis tests.
• Those who have undergone surgery within 3 months prior to the trial, plan to undergo surgery during the study, or have had surgery that affects drug absorption, distribution, metabolism, or excretion.
• Those who consumed more than 14 units of alcohol per week within 3 months prior to the trial (1 unit = 17.7 mL ethanol, i.e., 354 mL of 5% alcohol beer, 44 mL of 40% alcohol liquor, or 147 mL of 12% alcohol wine), or those unable to abstain from alcohol during the trial.
• Those who smoked an average of more than 5 cigarettes per day within 3 months prior to the trial, or those unable to stop using any tobacco-based or nicotine products (e.g., nicotine patches, chewing gums) during the trial.
• Those who consumed excessive amounts of tea, coffee, and/or caffeine-rich beverages (more than 8 cups, 1 cup = 250 mL) per day within 3 months prior to the trial.
• Those who consumed any food or beverage rich in caffeine/xanthine or other special ingredients (e.g., strong tea, coffee, chocolate, cola, animal offal, grapefruit, grapefruit juice, dragon fruit, mango) from screening to 2 days before admission, which, in the investigator's judgment, may affect drug absorption, distribution, metabolism, or excretion, or those unable to stop consuming such foods or beverages by the end of drug administration.
• Those who used any drugs that alter liver enzyme activity within 28 days prior to the trial (common liver enzyme inducers: barbiturates (phenobarbital being the most common), carbamazepine, aminoglutethimide, griseofulvin, meprobamate, phenytoin, glutethimide, rifampicin, dexamethasone; common liver enzyme inhibitors: chlorpromazine, cimetidine, ciprofloxacin, metronidazole, chloramphenicol, sulfonamides).
• Those who used any drugs affecting insulin's glucose-lowering effects within 28 days prior to the trial (e.g., corticosteroids, danazol, diazoxide, diuretics, epinephrine, salbutamol, terbutaline, glucagon, growth hormone, thyroid hormone, beta-blockers).

Sponsors & Collaborators

• Zhuhai United Laboratories Co., Ltd.: lead

Study Sites (1)

28 Baofeng Road, Qiaokou District

Wuhan, Hubei, 430000, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: A Single-Center, Randomized, Double-Blind, Two-Formulation, Single-Dose, Two-Period Crossover Clinical Trial
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A Single-Center, Randomized, Double-Blind, Two-Formulation, Single-Dose, Two-Period Crossover Clinical Trial

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 27, 2026
• Study Start: August 4, 2025
• Primary Completion: November 25, 2025
• Study Completion: January 13, 2026
• Last Updated: June 1, 2026

Record last verified: 2026-05

Locations

CN (1)