Study to Demonstrate Pharmacokinetic and Pharmacodynamic... | NCT06492226

NCT06492226

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Label	Type	Description	Intervention Names
NKF-INS(A)	Experimental	Single subcutaneous dose administration over three treatment periods	Drug: NKF-INS(A)
EU-NovoRapid®	Active Comparator	Single subcutaneous dose administration over three treatment periods	Drug: EU-NovoRapid®
US-NovoLog®	Active Comparator	Single subcutaneous dose administration over three treatment periods	Drug: US-NovoLog®

Name	Type	Description	Arm Group Labels	Other Names
NKF-INS(A)	Drug	Single subcutaneous dose of 0.3 U/kg administration over three treatment periods	NKF-INS(A)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	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.	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.	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.	Day 1 for 12 Hours

Secondary Outcomes

Measure	Description	Time Frame
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.	Day 1 for 12 Hours

Eligibility Module

Eligibility Criteria

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 plasma 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.
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.

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.
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.
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.

Facility	Status	City	State	ZIP	Country	Contacts
Xentria Investigative Site		Bloemfontein		9301	South Africa

Arm/Group Information

ID	Title	Description
FG000	NKF-INS(A), EU-NovoRapid, US-NovoLog	Participants first received NKF-INS(A) on Day 1 of Treatment Period 1. After a washout period of 3-14 calendar days, they then received EU-NovoRapid on Day 1 of Treatment Period 2. After an additional washout period of 5-21 calendar days, they then received US-NovoLog on Day 1 of Treatment Period 3.
FG001	NKF-INS(A), US-NovoLog, EU-NovoRapid	Participants first received NKF-INS(A) on Day 1 of Treatment Period 1. After a washout period of 3-14 calendar days, they then received US-NovoLog on Day 1 of Treatment Period 2. After an additional washout period of 5-21 calendar days, they then received EU-NovoRapid on Day 1 of Treatment Period 3.
FG002	EU-NovoRapid, NKF-INS(A), US-NovoLog	Participants first received EU-NovoRapid on Day 1 of Treatment Period 1. After a washout period of 3-14 calendar days, they then received NKF-INS(A) on Day 1 of Treatment Period 2. After an additional washout period of 5-21 calendar days, they then received US-NovoLog on Day 1 of Treatment Period 3.
FG003	EU-NovoRapid, US-NovoLog, NKF-INS(A)	Participants first received EU-NovoRapid on Day 1 of Treatment Period 1. After a washout period of 3-14 calendar days, they then received US-NovoLog on Day 1 of Treatment Period 2. After an additional washout period of 5-21 calendar days, they then received NKF-INS(A) on Day 1 of Treatment Period 3.
FG004	US-NovoLog, NKF-INS(A), EU-NovoRapid	Participants first received US-NovoLog on Day 1 of Treatment Period 1. After a washout period of 3-14 calendar days, they then received NKF-INS(A) on Day 1 of Treatment Period 2. After an additional washout period of 5-21 calendar days, they then received EU-NovoRapid on Day 1 of Treatment Period 3.
FG005	US-NovoLog, EU-NovoRapid, NKF-INS(A)	Participants first received US-NovoLog on Day 1 of Treatment Period 1. After a washout period of 3-14 calendar days, they then received EU-NovoRapid on Day 1 of Treatment Period 2. After an additional washout period of 5-21 calendar days, they then received NKF-INS(A) on Day 1 of Treatment Period 3.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	NKF-INS(A), EU-NovoRapid, US-NovoLog	Participants first received NKF-INS(A) on Day 1 of Treatment Period 1. After a washout period of 3-14 calendar days, they then received EU-NovoRapid on Day 1 of Treatment Period 2. After an additional washout period of 5-21 calendar days, they then received US-NovoLog on Day 1 of Treatment Period 3.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Customized			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

Posted

Geometric Mean

Geometric Coefficient of Variation

min*ng/ml

Day 1 for 12 Hours

ID	Title	Description
OG000	EU-NovoRapid®	Participants received a single subcutaneous dose of 0.3 IU/kg in either Treatment Period 1, Treatment Period 2, or Treatment Period 3
OG001	US-NovoLog®	Participants received a single subcutaneous dose of 0.3 IU/kg in either Treatment Period 1, Treatment Period 2, or Treatment Period 3

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	NKF-INS(A)	Single subcutaneous dose administration over three treatment periods NKF-INS(A): Single subcutaneous dose of 0.3 U/kg administration over three treatment periods

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	May 6, 2024	Aug 26, 2025	Prot_000.pdf
SAP	No	Yes	No	Statistical Analysis Plan	Oct 21, 2024	Aug 26, 2025	SAP_001.pdf