Pharmacokinetic and Pharmacodynamic Effects of Insulex® R in Comparison to Humulin® R in Healthy Subjects

Exclusion Criteria

• •1. Pregnant, lactating or intending to become pregnant during the study.
• •2. Subjects with confirmed diabetes type 1 or type 2.
• •3. Presence of any clinically significant co-morbidities, or physical exam, ECG, or laboratory findings at screening or upon clinic admission that, in the opinion of the Investigator, may interfere with any aspect of study conduct or interpretation of the study results.
• •4. Active or untreated malignancy or has been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for \< 5 years.
• •5. Supine heart rate \> 100 or \< 40 beats per minute at screening, based on the average of 3 consecutive measurements.
• •6. Supine systolic blood pressure \> 140 mm Hg or \< 90 mm Hg and/or diastolic blood pressure ≥ 90 mm Hg at Screening or upon clinic admission. If blood pressure is outside of the specified ranges, it may be repeated once 20-30 minutes later the same day.
• •7. Subjects with a prior history of any serious adverse reaction, hypersensitivity to study drugs or drug components.
• •8. History of any major surgery within 6 months prior to screening, per Investigator discretion.
• •9. History of any active infection, other than mild viral illness within 30 days prior to the first dose of study drug as judged by the Investigator.
• •10. History of any active infection, other than mild viral illness within 30 days prior to the first dose of study drug as judged by the Investigator.
• •11. History of regular use of nicotine-containing products (including but not limited to cigarettes, e-cigarettes, pipe, chewing tobacco, nicotine patch or gum) or vaping products within 3 months prior to check-in for the first in-house period. Subjects must refrain from using nicotine-containing products until after the completion of the Follow-Up Visit after the last dose of study drug.
• •12. History of drug abuse as judged by the Investigator or a positive urine drug test at Screening or upon clinic admission. Frequent use of marijuana or other tetrahydrocannabinol (THC) products within 6 weeks, or clinically under the effect at screening or upon clinic admission, as per Investigator evaluation or a positive urine drug test at Screening or upon clinic admission.
• •13. History of or positive test for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), or human immunodeficiency virus type 1 (HIV-1) or type 2 (HIV-2) antibody.
• •14. Subject is not able to avoid physical activity, avoid alcohol, caffeinated drinks, smoking or medication other than the study medication for 24 hours prior to and throughout the treatment period. (Herbal products and non-routine vitamins are not allowed within 14 days prior to dosing. Routine vitamins are permitted up to 48 hours prior to dosing. Chronic use of acetaminophen is excluded, but occasional use is permitted.) Adequate washout for any concomitant medication that may impact insulin's effect on blood glucose must be ensured and such medications cannot be used throughout the treatment period.
• •15. Laboratory or clinical evidence of current infection with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), i.e., COVID-19, at Screening or upon clinic admission or administration of an approved, authorized, or emergency use approved COVID-19 vaccine within 14 days prior to dosing with study drug.
• •16. Any anticipated/planned procedures (e.g., surgery), that interfere with the compliance or the subject's ability to complete the study.
• •17. Participation in an investigational study within 30 days prior to dosing or 5 half-lives within the last dose of investigational product whichever is longer.
• •18. Have previously participated, completed, or withdrawn from this study.
• •19. Donation or loss of \> 500 mL of whole blood within 8 weeks, platelets within 2 weeks and plasma within 4 weeks of the first dose of study drug. Receipt of blood products within 2 months prior to check-in.