CompletedPhase 1

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

South Africa54 participantsStarted 2025-10-13

Plain-language summary

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

Who can participate

Age range

18 Years – 50 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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 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.

Exclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

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

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

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.

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

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.

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

Trial details

NCT IDNCT07165652

SponsorXentria, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-03-02

View on ClinicalTrials.gov More Healthy Male Adult Volunteers trials

Who can participate

Age range

18 Years – 50 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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 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.

Exclusion criteria

. 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.