Healthy Male Adult VolunteersPhase 1NCT07165652
Study to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity Between NKF-INS(L), US-Humalog®, and EU-Humalog®
A Phase 1 study testing NKF-INS(L), US-Humalog® and EU-Humalog® in people with Healthy Male Adult Volunteers, run by Xentria, Inc. at 1 site in South Africa.
Trial summary
Study to demonstrate pharmacokinetic and pharmacodynamic similarity between NKF-INS(L), US-Humalog®, and EU-Humalog® Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Male Adult Volunteers
- What is being tested?
- NKF-INS(L), US-Humalog® and EU-Humalog®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSouth Africa
- Study dates
- 13 Oct 2025to 2 Mar 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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 treatment. Male participants must refrain from donating or banking sperm for 90 days after administration of study treatment.
- Have competence in speaking, writing, and comprehending the local language(s) where the study is conducted.
Who cannot join
- 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, or any specific investigational product safety concern
- History of diabetes mellitus; episodes of hypoglycemia in the anamnesis; any history of insulin use for treatment purposes.
- 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.
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- Clinically significant abnormal ECG at screening.
- Glycemia level ≥140 mg/dL 2 hours after the glucose load.
- 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.
- 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).
- Have donated blood or had a blood loss of 500 mL 3 months prior to study enrollment.
- 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).
- Employees or close relatives of the contract research organization, the sponsor, 3rd party vendors or affiliates of the above-mentioned parties
- Have inadequate venous access.
- Vulnerable participants, e.g., persons in detention.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
- Conditions
- Healthy Male Adult Volunteers
- Being tested
- NKF-INS(L), US-Humalog®, EU-Humalog®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NKF-INS(L)Drug
Participants will receive a single subcutaneous dose of 0.3 IU/kg in either Treatment Period 1, Treatment Period 2, or Treatment period 3.
US-Humalog®Drug
Participants will receive a single subcutaneous dose of 0.3 IU/kg in either Treatment Period 1, Treatment Period 2, or Treatment period 3.
EU-Humalog®Drug
Participants will receive a single subcutaneous dose of 0.3 IU/kg in either Treatment Period 1, Treatment Period 2, or Treatment period 3.
| Study group | Role | What they receive |
|---|---|---|
| NKF-INS Lispro (L) | Experimental | Participants will receive a single subcutaneous dose of each study intervention over 3 treatment periods Receives: Drug: NKF-INS(L) |
| United States (US)-Humalog® | Active comparator | Participants will receive a single subcutaneous dose of each study intervention over 3 treatment periods Receives: Drug: US-Humalog® |
| European Union (EU)-Humalog® | Active comparator | Participants will receive a single subcutaneous dose of each study intervention over 3 treatment periods Receives: Drug: EU-Humalog® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Maximum observed insulin lispro concentration (Cmax)
Measured: 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.
Area under the Glucose Infusion Rate (GIR)-time curve from 0 to 12 hours
Measured: 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.
Maximum GIR (GIRmax) of glucose.
Measured: Baseline to 720 minutes or the end of clamp procedure, whichever occurs first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start13 Oct 2025
- Primary completion2 Mar 2026
- Study completion2 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male Adult VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xentria, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07165652
- Sponsor's protocol ID
- NKF-INS(L)-101
- Status last verified
- Mar 2026
- First submitted
- 3 Sep 2025
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07165652
- Acronym / sponsor ID
- NKF-INS(L)-101
- Conditions
- Healthy Male Adult Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Xentria, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Oct 2025 (actual)
- Primary completion
- 2 Mar 2026 (actual)
- Study completion
- 2 Mar 2026 (actual)
- First posted
- 10 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study to demonstrate pharmacokinetic and pharmacodynamic similarity between NKF-INS(L), US-Humalog®, and EU-Humalog®
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NKF-INS Lispro (L) | Experimental | Drug: NKF-INS(L)Participants will receive a single subcutaneous dose of each study intervention over 3 treatment periods |
| United States (US)-Humalog® | Active comparator | Drug: US-Humalog®Participants will receive a single subcutaneous dose of each study intervention over 3 treatment periods |
| European Union (EU)-Humalog® | Active comparator | Drug: EU-Humalog®Participants will receive a single subcutaneous dose of each study intervention over 3 treatment periods |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (19 listed)
- 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, or any specific investigational product safety concern
- History of diabetes mellitus; episodes of hypoglycemia in the anamnesis; any history of insulin use for treatment purposes.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NKF-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. | Drug | NKF-INS Lispro (L) |
| US-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. | Drug | United States (US)-Humalog® |
| EU-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. | Drug | European Union (EU)-Humalog® |
Primary outcome
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
Time frame: Baseline to 720 minutes or the end of clamp procedure, whichever occurs first
Lispro concentration time curve from 0 to 12 hours
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
Time frame: Baseline to 720 minutes or the end of clamp procedure, whichever occurs first
Maximum observed insulin lispro concentration (Cmax)
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.
Time frame: Baseline to 720 minutes or the end of clamp procedure, whichever occurs first
Area under the Glucose Infusion Rate (GIR)-time curve from 0 to 12 hours
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.
Time frame: Baseline to 720 minutes or the end of clamp procedure, whichever occurs first
Maximum GIR (GIRmax) of glucose.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NKF-INS(L), US-Humalog® and EU-Humalog® in people with Healthy Male Adult Volunteers, run by Xentria, Inc. at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Baseline to 720 minutes or the end of clamp procedure, whichever occurs first). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.