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CompletedNCT07165652Updated Mar 6, 2026

Study to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity Between NKF-INS(L), US-Humalog®, and EU-Humalog®

A Phase 1 interventional study of NKF-INS(L) and US-Humalog® in Healthy Male Adult Volunteers, sponsored by Xentria, Inc.. Completed at 1 site in South Africa. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-06.

Sponsored by Xentria, Inc. · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Male
01

Study summary

Study to demonstrate pharmacokinetic and pharmacodynamic similarity between NKF-INS(L), US-Humalog®, and EU-Humalog®

Read the detailed description

A single center, single-dose, double-blind, randomized, three-period, three-treatment, six-sequence, crossover study to demonstrate pharmacokinetic and pharmacodynamic similarity between NKF-INS(L), US-Humalog®, and EU-Humalog® using the euglycemic clamp technique in healthy male adult volunteers

02

Conditions studied

  • Healthy Male Adult Volunteers
03

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  1. 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
  2. Healthy male participants
  3. Age between 18 and 50 years, both inclusive
  4. Body Mass Index between 18.5 and 29.0 kg/m2, both inclusive
  5. Body weight ≥ 50 kg
  6. Fasting glucose concentration ≤ 5.5 mmol/L at screening
  7. 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
  8. Willing and able to comply with scheduled visits, treatment plan, clinical laboratory tests, and other study procedures including lifestyle considerations.
  9. 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 treatment. Male participants must refrain from donating or banking sperm for 90 days after administration of study treatment.
  10. Have competence in speaking, writing, and comprehending the local language(s) where the study is conducted.

Exclusion criteria

Exclusion Criteria:

  1. Positive for human insulin antibodies at Screening
  2. 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.
  3. Have known allergies to insulin, its excipients, or related drugs or have history of relevant allergic reactions of any origin, or any specific investigational product safety concern
  4. History of diabetes mellitus; episodes of hypoglycemia in the anamnesis; any history of insulin use for treatment purposes.
  5. 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.
  6. 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.
  7. Clinically significant abnormal ECG at screening.
  8. Glycemia level ≥140 mg/dL 2 hours after the glucose load.
  9. Evidence of psychiatric disorder, antagonistic personality, poor motivation, emotional or intellectual problems likely to limit the validity of consent to participate in the study or limit the ability to comply with protocol requirements.
  10. 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.
  11. Show evidence of an acute infection with fever or infectious disease at the time of enrollment.
  12. Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies at screening.
  13. 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.
  14. 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).
  15. Have donated blood or had a blood loss of 500 mL 3 months prior to study enrollment.
  16. Have an average weekly alcohol intake that exceeds 21 units per week or is unwilling to stop alcohol consumption from 48 hours prior to each dosing until being discharged from the Clinical Research Unit (CRU).
  17. Employees or close relatives of the contract research organization, the sponsor, 3rd party vendors or affiliates of the above-mentioned parties
  18. Have inadequate venous access.
  19. Vulnerable participants, e.g., persons in detention.
04

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
54 participants (actual)

Study arms

  • Experimental
    NKF-INS Lispro (L)

    Participants will receive a single subcutaneous dose of each study intervention over 3 treatment periods

    Drug: NKF-INS(L)

  • Active comparator
    United States (US)-Humalog®

    Participants will receive a single subcutaneous dose of each study intervention over 3 treatment periods

    Drug: US-Humalog®

  • Active comparator
    European Union (EU)-Humalog®

    Participants will receive a single subcutaneous dose of each study intervention over 3 treatment periods

    Drug: EU-Humalog®

Interventions

  • DrugNKF-INS(L)

    Participants will receive a single subcutaneous dose of 0.3 IU/kg in either Treatment Period 1, Treatment Period 2, or Treatment period 3.

  • DrugUS-Humalog®

    Participants will receive a single subcutaneous dose of 0.3 IU/kg in either Treatment Period 1, Treatment Period 2, or Treatment period 3.

  • DrugEU-Humalog®

    Participants will receive a single subcutaneous dose of 0.3 IU/kg in either Treatment Period 1, Treatment Period 2, or Treatment period 3.

05

What researchers measure

Primary outcomes

  1. To compare the pharmacokinetics (PK) of NKF-INS Lispro(L) to United States (US)-approved and European Union (EU)-authorized Humalog to demonstrate PK similarity for insulin lispro

    Lispro concentration time curve from 0 to 12 hours

    Time frame: Baseline to 720 minutes or the end of clamp procedure, whichever occurs first

  2. To compare the pharmacokinetics (PK) of NKF-INS Lispro(L) to United States (US)-approved and European Union (EU)-authorized Humalog to demonstrate PK similarity for insulin lispro

    Maximum observed insulin lispro concentration (Cmax)

    Time frame: Baseline to 720 minutes or the end of clamp procedure, whichever occurs first

  3. To compare the pharmacodynamics (PD) of NKF-INS(L) to US-approved and EU-authorized Humalog by examining GIR profiles after a single subcutaneous (SC) dose.

    Area under the Glucose Infusion Rate (GIR)-time curve from 0 to 12 hours

    Time frame: Baseline to 720 minutes or the end of clamp procedure, whichever occurs first

  4. To compare the pharmacodynamics (PD) of NKF-INS(L) to US-approved and EU-authorized Humalog by examining GIR profiles after a single subcutaneous (SC) dose.

    Maximum GIR (GIRmax) of glucose.

    Time frame: Baseline to 720 minutes or the end of clamp procedure, whichever occurs first

06

Study locations

1 site
  • FARMOVS
    Bloemfontein, 9301, South Africa
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07165652
Lead sponsor
Xentria, Inc.
Responsible party
Sponsor
First posted
Sep 10, 2025
Start date
Oct 13, 2025
Primary completion
Mar 2, 2026
Completion
Mar 2, 2026
Last update
Mar 6, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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