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
Overview
- Phase
- Phase 1
- Intervention
- NKF-INS(A)
- Conditions
- Healthy Participants
- Sponsor
- Xentria, Inc.
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- To compare the PD of NKF-INS(A) to US-approved and EU-authorized insulin aspart injection by examining GIR profiles after a single SC dose.
- Status
- Completed
- Last Updated
- 3 months ago
Overview
Brief 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®
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
Investigators
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.
Arms & Interventions
NKF-INS(A)
Single subcutaneous dose administration over three treatment periods
Intervention: NKF-INS(A)
EU-NovoRapid®
Single subcutaneous dose administration over three treatment periods
Intervention: EU-NovoRapid®
US-NovoLog®
Single subcutaneous dose administration over three treatment periods
Intervention: US-NovoLog®
Outcomes
Primary Outcomes
To compare the PD of NKF-INS(A) to US-approved and EU-authorized insulin aspart injection by examining GIR profiles after a single SC dose.
Time Frame: Day 1 for 12 Hours
Maximum GIR (GIRmax) of glucose
To compare the PK of NKF-INS(A) to US-approved and EU-authorized insulin aspart to demonstrate PK similarity for insulin aspart.
Time Frame: Day 1 for 12 Hours
Maximum observed insulin aspart concentration (Cmax)
Secondary Outcomes
- To evaluate additional PK parameters of NKF-INS(A) compared to US-approved and EU-authorized insulin aspart.(Day 1 for 12 Hours)