Healthy ParticipantsPhase 1NCT06492226

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

A Phase 1 study testing NKF-INS(A), EU-NovoRapid® and US-NovoLog® in people with Healthy Participants, run by Xentria, Inc. at 1 site in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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® 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 Participants
What is being tested?: NKF-INS(A), EU-NovoRapid® and US-NovoLog®
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: 30 Jul 2024to 31 Oct 2024
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 plasma glucose concentration ≤ 5.5 mmol/L at screening

Show all 10Show fewer

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.

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.
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.

Show all 17Show fewer

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).
Have donated blood or had a blood loss of 450 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 CRU.

Trial locations and contacts

1 site in 1 country.

South Africa1 site

Xentria Investigative Site
Bloemfontein, 9301

Other trials in South Africa

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(A), US-NovoLog®, and EU-NovoRapid® Using the Euglycemic Clamp Technique in Healthy Male Adult Volunteers

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(A), US-NovoLog®, and EU-NovoRapid® using the euglycemic clamp technique in healthy male adult volunteers

Conditions: Healthy Participants
Being tested: NKF-INS(A), EU-NovoRapid®, US-NovoLog®

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NKF-INS(A)Drug
Single subcutaneous dose of 0.3 U/kg administration over three treatment periods
EU-NovoRapid®Drug
Single subcutaneous dose of 0.3 U/kg administration over three treatment periods
US-NovoLog®Drug
Single subcutaneous dose of 0.3 U/kg administration over three treatment periods

Study groups in NCT06492226
Study group	Role	What they receive
NKF-INS(A)	Experimental	Single subcutaneous dose administration over three treatment periods Receives: Drug: NKF-INS(A)
EU-NovoRapid®	Active comparator	Single subcutaneous dose administration over three treatment periods Receives: Drug: EU-NovoRapid®
US-NovoLog®	Active comparator	Single subcutaneous dose administration over three treatment periods Receives: Drug: US-NovoLog®

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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-∞
Evaluated additional Pharmacokinetic (PK) parameters of NKF-INS(A) compared to United Stated (US)-approved and European Union (EU)-authorized insulin aspart.
Measured: 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)
Evaluated Additional Pharmacokinetic (PK) Parameters of NKF-INS(A) Compared to United States (US)-Approved and European (EU)-Authorized Insulin Aspart.
Measured: 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)
Evaluated additional Pharmacokinetic (PK) parameters of NKF-INS(A) compared to United Stated (US)-approved and European Union (EU)-authorized insulin aspart.
Measured: Day 1 for 12 Hours
The Terminal Elimination Half-life (t1/2)
Evaluated additional Pharmacokinetic (PK) parameters of NKF-INS(A) compared to United Stated (US)-approved and European Union (EU)-authorized insulin aspart.
Measured: 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)
Evaluated additional Pharmacokinetic (PK) parameters of NKF-INS(A) compared to United Stated (US)-approved and European Union (EU)-authorized insulin aspart.
Measured: Day 1 for 12 Hours
PK Parameters for Serum Insulin Aspart Concentrations: Area Under the Insulin Aspart Concentration-Time Curve AUC6-12h
Evaluated additional Pharmacokinetic (PK) parameters of NKF-INS(A) compared to United Stated (US)-approved and European Union (EU)-authorized insulin aspart.
Measured: Day 1 for 12 Hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jul 202431 Oct 2024

First posted9 Jul 2024
Study start30 Jul 2024
Primary completion31 Oct 2024
Study completion31 Oct 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy ParticipantsStudies 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)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06492226
Sponsor's protocol ID: NKF-INS(A)-101
Status last verified: Jan 2026
First submitted: 1 Jul 2024
Last updated: 21 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 21 Jan 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(A), US-NovoLog®, and EU-NovoRapid® Using the Euglycemic Clamp Technique in Healthy Male Adult Volunteers
ClinicalTrials.gov ID: NCT06492226
Acronym / sponsor ID: NKF-INS(A)-101
Conditions: Healthy Participants
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 54 participants (actual)
Lead sponsor: Xentria, Inc.Industry (pharma, biotech, devices)
Study start: 30 Jul 2024 (actual)
Primary completion: 31 Oct 2024 (actual)
Study completion: 31 Oct 2024 (actual)
First posted: 9 Jul 2024 (actual)
Results: Posted 21 Jan 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
NKF-INS(A)	Experimental	Drug: NKF-INS(A)Single subcutaneous dose administration over three treatment periods
EU-NovoRapid®	Active comparator	Drug: EU-NovoRapid®Single subcutaneous dose administration over three treatment periods
US-NovoLog®	Active comparator	Drug: US-NovoLog®Single subcutaneous dose administration over three 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 (17 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.
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.

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(A)Single subcutaneous dose of 0.3 U/kg administration over three treatment periods	Drug	NKF-INS(A)
EU-NovoRapid®Single subcutaneous dose of 0.3 U/kg administration over three treatment periods	Drug	EU-NovoRapid®
US-NovoLog®Single subcutaneous dose of 0.3 U/kg administration over three treatment periods	Drug	US-NovoLog®

Primary outcome

Aspart Concentration-time Curve From 0 to 12 Hours Area Under the Insulin Aspart Concentration-Time Curve (AUC0-t).
Time frame: Day 1 for 12 Hours
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.
Maximum Observed Insulin Aspart Concentration Maximum Observed Insulin Aspart Concentration (Cmax)
Time frame: Day 1 for 12 Hours
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.
Area Under the GIR-time Curve From 0 to 12 Hours (AUCGIR0-t).
Time frame: Day 1 for 12 Hours
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.
Maximum GIR (GIRmax) of Glucose
Time frame: Day 1 for 12 Hours
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.

6 secondary outcomes

PK Parameters for Serum Insulin Aspart Concentrations: Area Under the Insulin Aspart Concentration-Time Curve (AUC0)-4h, AUC0-6h, AUC0-12h, AUC0-∞
Time frame: 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)
Time frame: 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)
Time frame: Day 1 for 12 Hours
The Terminal Elimination Half-life (t1/2)
Time frame: 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)
Time frame: Day 1 for 12 Hours
PK Parameters for Serum Insulin Aspart Concentrations: Area Under the Insulin Aspart Concentration-Time Curve AUC6-12h
Time frame: Day 1 for 12 Hours

Results and safety

Results posted to the registry on 21 Jan 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
NKF-INS(A), EU-NovoRapid, US-NovoLog	9	8
NKF-INS(A), US-NovoLog, EU-NovoRapid	9	9
EU-NovoRapid, NKF-INS(A), US-NovoLog	9	8
EU-NovoRapid, US-NovoLog, NKF-INS(A)	9	9
US-NovoLog, NKF-INS(A), EU-NovoRapid	9	9
US-NovoLog, EU-NovoRapid, NKF-INS(A)	9	9

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

Time frame: Day 1 for 12 Hours. Geometric mean (Geometric Coefficient of Variation). Unit: min*ng/ml

Measure	EU-NovoRapid® n = 52	US-NovoLog® n = 52	NKF-INS(A) n = 52
Value	894.971 (18.426)	899.163 (18.711)	904.131 (17.174)

EU-NovoRapid® vs NKF-INS(A): Geometric Mean Ratio: 101.024 (95% CI 98.754 to 103.346)
US-NovoLog® vs NKF-INS(A): Geometric Mean Ratio: 100.682 (90% CI 98.567 to 102.843)

Primary outcome: Maximum Observed Insulin Aspart Concentration Maximum Observed Insulin Aspart Concentration (Cmax)

Time frame: Day 1 for 12 Hours. Geometric mean (Geometric Coefficient of Variation). Unit: ng/ml

Measure	EU-NovoRapid® n = 52	US-NovoLog® n = 52	NKF-INS(A) n = 52
Value	1.754 (16.331)	1.754 (17.492)	1.805 (15.255)

EU-NovoRapid® vs NKF-INS(A): Geometric Mean Ratio: 104.931 (95% CI 99.630 to 110.514)
US-NovoLog® vs NKF-INS(A): Geometric Mean Ratio: 105.000 (90% CI 100.827 to 109.345)

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

Time frame: Day 1 for 12 Hours. Geometric mean (Geometric Coefficient of Variation). Unit: min*mg/min

Measure	EU-NovoRapid® n = 52	US-NovoLog® n = 52	NKF-INS(A) n = 52
Value	166278.835 (25.467)	167245.347 (26.287)	171020.184 (26.779)

EU-NovoRapid® vs NKF-INS(A): Geometric Mean Ratio: 102.851 (95% CI 96.749 to 109.339)
US-NovoLog® vs NKF-INS(A): Geometric Mean Ratio: 102.006 (90% CI 97.308 to 106.930)

Primary outcome: Maximum GIR (GIRmax) of Glucose

Time frame: Day 1 for 12 Hours. Geometric mean (Geometric Coefficient of Variation). Unit: mg/min

Measure	EU-NovoRapid® n = 52	US-NovoLog® n = 52	NKF-INS(A) n = 52
Value	604.789 (26.670)	619.459 (29.184)	608.934 (26.825)

EU-NovoRapid® vs NKF-INS(A): Geometric Mean Ratio: 100.685 (95% CI 94.956 to 106.760)
US-NovoLog® vs NKF-INS(A): Geometric Mean Ratio: 97.980 (90% CI 92.554 to 103.723)

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Beginning of study treatment (Day 1) until the End of Study Visit (within 2-11 days of last administration of study drug). Adverse event (AE) assessments (including injection site reactions), clinical laboratory investigations (hematology, clinical chemistry [including glucose], coagulation, and urinalysis), vital signs, physical examinations, 12-lead electrocardiogram (ECG), prior and concomitant medication assessments. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
NKF-INS(A)	0 of 53 (0%)	8 of 53 (15.1%)	0 of 53
EU-NovoRapid®	0 of 53 (0%)	6 of 53 (11.3%)	0 of 53
US-NovoLog®	0 of 52 (0%)	4 of 52 (7.7%)	0 of 52

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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(A), EU-NovoRapid® and US-NovoLog® in people with Healthy Participants, 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 17 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 21 Jan 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?

Yes. Results are posted in the registry (first posted 21 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Aspart Concentration-time Curve From 0 to 12 Hours Area Under the Insulin Aspart Concentration-Time Curve (AUC0-t). (time frame: Day 1 for 12 Hours). 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?

On the ClinicalTrials.gov record for NCT06492226.

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 21 Jan 2026.