A Phase 1 interventional study of NKF-INS(L) and US-Humalog® in Healthy Male Adult Volunteers, sponsored by Xentria, Inc.. Completed at 1 site in South Africa. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-06.
Sponsored by Xentria, Inc. · Phase 1, Interventional, and Other
Study to demonstrate pharmacokinetic and pharmacodynamic similarity between NKF-INS(L), US-Humalog®, and EU-Humalog®
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
Exclusion Criteria:
Participants will receive a single subcutaneous dose of each study intervention over 3 treatment periods
Drug: NKF-INS(L)
Participants will receive a single subcutaneous dose of each study intervention over 3 treatment periods
Drug: US-Humalog®
Participants will receive a single subcutaneous dose of each study intervention over 3 treatment periods
Drug: 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.
Participants will receive a single subcutaneous dose of 0.3 IU/kg in either Treatment Period 1, Treatment Period 2, or Treatment period 3.
Participants will receive a single subcutaneous dose of 0.3 IU/kg in either Treatment Period 1, Treatment Period 2, or Treatment period 3.
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
Time frame: 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)
Time frame: 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
Time frame: 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.
Time frame: Baseline to 720 minutes or the end of clamp procedure, whichever occurs first
Plan to share: No
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This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Xentria, Inc.