Comparison of the Pharmacokinetic (PK) and Pharmacodynamic (PD) Biosimilarity of Insulin Aspart 30 Injections After Single-Dose Subcutaneous Administration to Healthy Volunteers

NCT07875803 | Not Yet Recruiting

• 1 other identifier: TUL-MDYDS30（PK/PD）202612
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The present study is designed to compare the pharmacokinetic, pharmacodynamic and safety characteristics of UBLIN 30® (test product) and NovoMix®30 (reference product) in healthy male participants. The treatment consists of one single dose of the test or reference product, administered during each of the two study periods, separated by 7 days between dosing. A total of 52 participants will be enrolled in this trial and randomized in a 1:1 ratio into two groups (A/B), stratified by race (Asian, non-Asian).

Conditions

Pharmacokinetics and Pharmacodynamics

Outcome Measures

Primary Outcomes (4)

• Area Under the Curve (AUC）of Insulin Aspart Plasma Concentration From Time 0 to τ (a dosing interval of 24 h)，AUC0-τ

  0 to 36 hours

• Peak Plasma Concentration of Insulin Aspart, Cmax

  0 to 36 hours

• Area Under The Curve (AUC) of Glucose Infusion Rate(GIR) From Time 0 to τ (a dosing interval of 24 h)，AUCGIR,0-τ

  0 to 24 hours

• Maximum Glucose Infusion Rate, GIRmax

  0 to 24 hours

Secondary Outcomes (13)

• Area Under the Curve (AUC) of Insulin Aspart Plasma Concentration From Time 0 to 4 Hours Post--Dose, AUC0-4h

  0 to 4 hours

• Area Under the Curve (AUC) of Insulin Aspart Plasma Concentration From 4 Hours Post-dose to the Time of Last Measurable Concentration, AUC4-t

  4 to 36 hours

• Area Under the Curve (AUC} of Insulin Aspart Plasma Concentration From Time 0 to the Time of Last Measurable Concentration, AUC0-t

  0 to 36 hours

• Area Under the Curve (AUC）of Insulin Aspart Plasma Concentration From Time 0 to the Time of infinity, AUC0-∞

  0 to 36 hours

• Time to Reach Peak Plasma Concentration of Insulin Aspart,Tmax

  0 to 36 hours

Study Arms (2)

UBLIN 30®

EXPERIMENTAL

Single subcutaneous administration of UBLIN 30® in dose 0.3 U/kg

Drug: Insulin Aspart 30 Injection (UBLIN 30®))

NovoMix®30

ACTIVE COMPARATOR

Single subcutaneous administration of NovoMix®30 in dose 0.3 U/kg

Drug: Insulin Aspart 30 Injection ( NovoMix®30)

Interventions

Insulin Aspart 30 Injection (UBLIN 30®)) DRUG

The dosage per cycle is 0.3 U/kg

UBLIN 30®

Insulin Aspart 30 Injection ( NovoMix®30) DRUG

The dosage per cycle is 0.3 U/kg

NovoMix®30

Eligibility Criteria

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

You may qualify if:

• Healthy male participants aged 18 to 55 years (inclusive).
• Body weight: Male ≥ 50.0 kg, body mass index \[BMI = weight (kg)/height2 (m2)\] between 19.0 and 28.0 kg/m2 (inclusive).
• Individuals with normal vital signs or abnormalities without clinical significance (normal reference range: 90 mmHg ≤ systolic blood pressure (supine) \< 140 mmHg, 60 mmHg ≤ diastolic blood pressure (supine) \< 90 mmHg, 60 beats/min ≤ pulse \< 100 beats/min, 36.0°C ≤ body temperature ≤ 37.0°C).
• mmol/L \< fasting plasma glucose (FPG) \< 6.10 mmol/L, 2-hour postprandial blood glucose after oral glucose tolerance test (OGTT) \< 7.80 mmol/L, glycated haemoglobin value between 4.0% and 6.0% (inclusive), and normal insulin secretion function (as determined by the investigator based on insulin release test results).
• Has fully understood the nature, significance, potential benefits, possible inconveniences, and potential risks of the trial before participation, voluntarily participates in this clinical trial, being able to communicate well with the investigator, complying with all study requirements, and has signed the written informed consent form.

You may not qualify if:

• History of specific allergies (e.g., asthma, urticaria, eczema), or those allergic to any drug, food, or pollen, or known to be allergic to insulin;
• History of hereditary galactose intolerance, lactase deficiency, or glucose-galactose malabsorption;
• Has a history of severe vomiting, diarrhoea within 7 days prior to the trial, or has any other disease or physiological condition that may interfere with the trial results;
• Has undergone surgery within 3 months prior to the study, or plans to undergo surgery during the study period; or has undergone any surgery that may affect drug absorption, distribution, metabolism, or excretion;
• Has a history of asthma or seizure disorder;
• Has participated in any other investigational product or device clinical trial and received investigational product within 3 months prior to the study (except for screening-only, non-enrolled cases or enrolled cases with no study-treatment exposure);
• Has taken any medications that alter liver enzyme activity within 28 days prior to the trial (common liver enzyme inducers: barbiturates (phenobarbital is the most common), carbamazepine, aminoglutethimide, griseofulvin, meprobamate, phenytoin, glutethimide, rifampicin, dexamethasone; common liver enzyme inhibitors: chlorpromazine, cimetidine, ciprofloxacin, metronidazole, chloramphenicol, sulfonamides);
• Has taken any medications that affect the hypoglycemic effect of insulin within 28 days prior to the trial (e.g., corticosteroids, danazol, diazoxide, diuretics, epinephrine, albuterol, terbutaline, glucagon, growth hormone, thyroid hormones, beta-blockers, etc.);
• Has used any prescription drugs, over-the-counter drugs, health supplements, herbal medicines, or received vaccinations within 14 days prior to the trial;
• Has any clinically significant abnormality identified by the investigator in general physical examination, laboratory tests (including hematology, blood biochemistry, coagulation, urinalysis, etc.), or 12-lead ECG within 14 days prior to the study;
• Has clinically significant abnormalities in glutamic acid decarboxylase autoantibodies (GAD), islet cell cytoplasmic autoantibodies (ICA), or insulin autoantibodies (IAA) results as judged by the investigator;
• Has clinically significant abnormalities in hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus (HIV) antibody, or syphilis-specific antibody tests;
• Has a breath alcohol test result \> 0.0 mg/100 mL or a positive drug abuse screening;
• Has used any illicit drugs within one year prior to the trial;
• Has consumed more than 14 units of alcohol per week within 3 months prior to the trial (1 unit = 17.7 mL of ethanol, i.e., 1 unit = 354 mL of beer with 5% alcohol, or 44 mL of liquor with 40% alcohol, or 147 mL of wine with 12% alcohol), or is unable to abstain from alcohol during the trial;

Sponsors & Collaborators

• Zhuhai United Laboratories Co., Ltd.: lead

Study Sites (1)

The Second Affiliated Hospital of Xingtai Medical College (Xingtai Cancer Hospital)

Xingtai, Hebei, 054000, China

Location

Study Officials

• Fengxue Guo

  The Second Affiliated Hospital of Xingtai Medical College (Xingtai Cancer Hospital)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qingtong Zhang

CONTACT

15096316761; zhangqt_0232@tul.com.cn

Fengxue Guo

CONTACT

0319-2279911; fxguo2023@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Two-Treatment, Two-period, Two-sequence Crossover

Study Record Dates

• First Submitted: October 8, 2026
• First Posted: October 15, 2026
• Study Start (Estimated): October 20, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: October 15, 2026

Record last verified: 2026-10

Locations

CN (1)