ClinicalTrials.gg
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

In context

Lead sponsor

Xentria, Inc. is the lead sponsor of 10 studies on the registry; 2 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 3 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Signed and dated 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. 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, (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 . 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 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 , 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 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 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 (HIV) infection and/or positive human HIV antibodies at screening.
  13. Have positive test results for surface antigen (HBsAg), immunoglobulin M (IgM) antibody to hepatitis B core antigen (anti-HBc), or 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.
Terms in these criteria, in plain language(10)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

05

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.

06

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

07

Study locations

1 site
  • FARMOVS
    Bloemfontein, 9301, South Africa
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2025 to primary completion in Mar 2026, 4 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 3, 2025
First posted
Sep 10, 2025
StartActual
Oct 13, 2025
Primary completionActual
Mar 2, 2026
CompletionActual
Mar 2, 2026
Last update
Mar 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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 ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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