Study to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity Between NKF-INS(A), US-NovoLog®, and EU-NovoRapid®

NCT06492226 | Completed Phase 1 Results FDA Drug

• 1 other identifier: NKF-INS(A)-101
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

Single-dose, double-blind, randomized, three-period, three-treatment, six-sequence, crossover study to demonstrate pharmacokinetic and pharmacodynamic similarity between NKF-INS(A), US-NovoLog®, and EU-NovoRapid®

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (4)

• Aspart Concentration-time Curve From 0 to 12 Hours Area Under the Insulin Aspart Concentration-Time Curve (AUC0-t).

  Compared the Pharmacokinetics (PK) of NKF-INS(A) to United States (US)-approved and European Union (EU)-authorized insulin aspart demonstrating PK similarity for insulin aspart.

  Day 1 for 12 Hours

• Maximum Observed Insulin Aspart Concentration Maximum Observed Insulin Aspart Concentration (Cmax)

  Compared the Pharmacokinetic (PK) of NKF-INS(A) to United States (US)-approved and European Union (EU)-authorized insulin aspart demonstrating PK similarity for insulin aspart.

  Day 1 for 12 Hours

• Area Under the GIR-time Curve From 0 to 12 Hours (AUCGIR0-t).

  Compared the Pharmacodynamic (PD) of NKF-INS(A) to United States (US)-approved and European Union (EU)-authorized insulin aspart injection by examining Glucose Infusion Rate (GIR) profiles after a single Subcutaneous (SC) dose.

  Day 1 for 12 Hours

• Maximum GIR (GIRmax) of Glucose

  Compared the Pharmacodynamic (PD) of NKF-INS(A) to United States (US)-approved and European Union (EU)-authorized insulin aspart injection by examining Glucose Infusion Rate (GIR) profiles after a single Subcutaneous (SC) dose.

  Day 1 for 12 Hours

Secondary Outcomes (6)

• PK Parameters for Serum Insulin Aspart Concentrations: Area Under the Insulin Aspart Concentration-Time Curve (AUC0)-4h, AUC0-6h, AUC0-12h, AUC0-∞

  Day 1 for 12 Hours

• Time to Half-maximum Before Maximum Observed Insulin Aspart Concentration Time to Half-Maximum Before Maximum Observed Insulin Aspart Concentration (t50%-Early)

  Day 1 for 12 Hours

• Time to Half-maximum After Maximum Observed Insulin Aspart Concentration Time to Half-Maximum After Maximum Observed Insulin Aspart Concentration (t50%-Late)

  Day 1 for 12 Hours

• The Terminal Elimination Half-life (t1/2)

  Day 1 for 12 Hours

• PK Parameters for Serum Insulin Aspart Concentrations: Area Under the Insulin Aspart Concentration-Time Curve to Maximum Insulin Aspart Concentration (Tmax)

  Day 1 for 12 Hours

Study Arms (3)

NKF-INS(A)

EXPERIMENTAL

Single subcutaneous dose administration over three treatment periods

Drug: NKF-INS(A)

EU-NovoRapid®

ACTIVE COMPARATOR

Single subcutaneous dose administration over three treatment periods

Drug: EU-NovoRapid®

US-NovoLog®

ACTIVE COMPARATOR

Single subcutaneous dose administration over three treatment periods

Drug: US-NovoLog®

Interventions

NKF-INS(A) DRUG

Single subcutaneous dose of 0.3 U/kg administration over three treatment periods

NKF-INS(A)

EU-NovoRapid® DRUG

Single subcutaneous dose of 0.3 U/kg administration over three treatment periods

EU-NovoRapid®

US-NovoLog® DRUG

Single subcutaneous dose of 0.3 U/kg administration over three treatment periods

US-NovoLog®

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Signed and dated informed consent obtained before any trial-related activities. Trial-related activities are any procedures that would not have been done during normal management of the participant
• Healthy male participants
• Age between 18 and 50 years, both inclusive
• Body Mass Index between 18.5 and 29.0 kg/m2, both inclusive
• Body weight ≥ 50 kg
• Fasting plasma glucose concentration ≤ 5.5 mmol/L at screening
• Considered generally healthy upon completion of medical history, physical examination, vital signs, electrocardiogram (ECG), and analysis of laboratory safety variables, as judged by the Investigator
• Willing and able to comply with scheduled visits, treatment plan, clinical laboratory tests, and other study procedures including lifestyle considerations.
• Participants must agree to use condoms during sexual intercourse. Additionally, female partners of male participants should use highly effective contraception. All contraceptive measures apply from screening until 90 days after study
• Have competence in speaking, writing, and comprehending the local language(s) where the study is conducted.

You may not qualify if:

• Positive for human insulin antibodies at Screening
• Are currently enrolled in or have discontinued within 3 months or 5 half-lives (whichever is longer) of any investigational drug or device or are concurrently enrolled in any other type of medical research study and judged not to be scientifically or medically compatible with this study.
• Have known allergies to insulin, its excipients, or related drugs or have history of relevant allergic reactions of any origin.
• History of diabetes mellitus; episodes of hypoglycemia in the anamnesis; any history of insulin use for treatment purposes.
• Have known allergies to insulin, its excipients, or related drugs or have history of relevant allergic reactions of any origin.
• Have clinically relevant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study drug; or of interfering with the interpretation of data.
• Increased risk of thrombosis, e.g., individuals with a history of deep leg vein thrombosis or family history of deep leg vein thrombosis, as judged by the Investigator.
• Clinically significant abnormal ECG at screening.
• Glycemia level ≥140.4 mg/dL 2 hours after the glucose load.
• Show evidence of significant active neuropsychiatric disease.
• Positive urine drug test at screening and/or evidence of current use of known drugs of abuse or have a history of use within the past year.
• Show evidence of an acute infection with fever or infectious disease at the time of enrollment.
• Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies at screening.
• Have positive test results for hepatitis B surface antigen (HBsAg), immunoglobulin M (IgM) antibody to hepatitis B core antigen (anti-HBc), or hepatitis C virus (HCV) antibodies at screening.
• Intend to use over-the-counter medication within 7 days or prescription medication within 14 days prior to dosing (apart from vitamin/mineral supplements, occasional paracetamol, thyroid replacement).

Sponsors & Collaborators

• Xentria, Inc.: lead

Study Sites (1)

Xentria Investigative Site

Bloemfontein, 9301, South Africa

Location

Results Point of Contact

• Title: Vice President, Clinical Developement
• Organization: Xentria, Inc

tmatthews@xentria.com

2244434615

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: July 1, 2024
• First Posted: July 9, 2024
• Study Start: July 30, 2024
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: January 21, 2026
• Results First Posted: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)