Phase 3
N=69
Comparison of the Pharmacokinetics (PK) and Pharmacodynamics (PD) Biosimilarity of Proposed Biosimilar Rapid-Acting Insulin Aspart (I004) and NovoLog After Single-Dose Subcutaneous Administration to Healthy Volunteers
Pharmacokinetics · Pharmacodynamics
Bottom Line
View on ClinicalTrials.gov: NCT05539872 ↗Enrolled (actual)
69
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcome: Primary: Maximum Serum Insulin Aspart Concentration, CIAmax — 2961.8; 2827.4 pg/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- I004 (Drug); NovoLog (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Amphastar Pharmaceuticals, Inc.
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Serum Insulin Aspart Concentration, CIAmax |
2961.8; 2827.4 | — |
| PRIMARY Area Under the Curve (AUC) of Insulin Aspart Serum Concentration From Time 0 to 12 Hours Post-dose, AUCIA(0-12h) |
7215.0; 6976.9 | — |
| PRIMARY Maximum Glucose Infusion Rate, Gmax |
10.3; 10.3 | — |
| PRIMARY Area Under the Curve (AUC) for Glucose Infusion Rate From Time 0 to 12 Hours Post-dose, AUCG(0-12h) |
1906.9; 1985.7 | — |
| SECONDARY Area Under the Curve (AUC) of Insulin Aspart Serum Concentration From Time 0 to Infinity, AUCIA(0-∞) |
7374.9; 7202.7 | — |
| SECONDARY Area Under the Curve (AUC) of Insulin Aspart Serum Concentration From Time 0 to 1 Hour Post-dose, AUCIA(0-1h) |
1438.9; 1496.6 | — |
| SECONDARY Area Under the Curve (AUC) of Insulin Aspart Serum Concentration From Time 0 to 2 Hours Post-dose, AUCIA(0-2h) |
3886.9; 3757.0 | — |
| SECONDARY Area Under the Curve (AUC) of Insulin Aspart Serum Concentration From Time 0 to 4 Hours Post-dose, AUCIA(0-4h) |
6478.7; 6204.1 | — |
| SECONDARY Area Under the Curve (AUC) of Insulin Aspart Serum Concentration From 4 to 12 Hours Post-dose, AUCIA(4-12h) |
567.2; 619.8 | — |
| SECONDARY Time of Maximum Insulin Aspart Serum Concentration, tIAmax |
67.5; 55.0 | — |
| SECONDARY Apparent Clearance of Insulin Aspart, CL/F |
74.2; 76.3 | — |
| SECONDARY Apparent Volume of Distribution of Insulin Aspart, Vz/F |
96.8; 104.1 | — |
| SECONDARY Half-life of Insulin Aspart, t1/2 |
53.0; 60.8 | — |
| SECONDARY Maximum Serum Human Insulin Concentration, CHImax |
559.4; 563.8 | — |
| SECONDARY Area Under the Curve (AUC) of Human Insulin Serum Concentration From Time 0 to 12 Hours Post-dose, AUCHI(0-12h) |
2662.7; 2634.8 | — |
| SECONDARY Time of Maximum Human Insulin Serum Concentration, tHImax |
80.0; 105.0 | — |
| SECONDARY Area Under the Curve (AUC) for Glucose Infusion Rate Due to Insulin Aspart From Time 0 to 12 Hours Post-dose, AUCGA(0-12h) |
1308.1; 1364.8 | — |
| SECONDARY Maximum Glucose Infusion Rate Due to Insulin Aspart, GAmax |
8.1; 8.3 | — |
| SECONDARY Area Under the Curve (AUC) for Glucose Infusion Rate (GIR) From Time 0 to the Time of Last Measurable GIR, AUCG(0-last) |
1906.9; 1985.7 | — |
| SECONDARY Area Under the Curve (AUC) for Glucose Infusion Rate From Time 0 to 1 Hour Post-dose, AUCG(0-1h) |
115.8; 123.6 | — |
| SECONDARY Area Under the Curve (AUC) for Glucose Infusion Rate From Time 0 to 2 Hours Post-dose, AUCG(0-2h) |
481.5; 501.9 | — |
| SECONDARY Area Under the Curve (AUC) for Glucose Infusion Rate From Time 0 to 4 Hours Post-dose, AUCG(0-4h) |
1268.9; 1305.0 | — |
| SECONDARY Area Under the Curve (AUC) for Glucose Infusion Rate From Time 4 to 12 Hours Post-dose, AUCG(4-12h) |
555.9; 589.3 | — |
| SECONDARY Last Measurable Glucose Infusion Rate, Glast |
0.1; 0.0 | — |
| SECONDARY Time of Maximum Glucose Infusion Rate, tGmax |
160.0; 136.0 | — |
| SECONDARY Time of Glucose Infusion Start, tGonset |
22.0; 20.0 | — |
| SECONDARY Time of Last Measurable Glucose Infusion Rate, tGlast |
720.0; 712.0 | — |
| SECONDARY Time to Half of Maximum Glucose Infusion Rate (Gmax) Before Gmax Is Reached, tG50%Early |
76.7; 71.5 | — |
| SECONDARY Time to Half of Maximum Glucose Infusion Rate (Gmax) After Gmax Is Reached, tG50%Late |
211.9; 216.2 | — |
Summary
This study is a randomized, double-blinded, two-treatment, two-period, two-sequence crossover pivotal Biosimilar study. The purpose of this study is to establish pharmacokinetic (PK) and pharmacodynamics (PD) biosimilarity of proposed biosimilar I004 and the US-approved NovoLog.
Eligibility Criteria
Inclusion Criteria
- Upon review, agree to participate and sign informed consent.
- Healthy male and female subjects ≥ 18 to ≤ 65 years of age.
- Body mass index (BMI) ≥ 18.5 to ≤ 29.9 kg/m2
- Weight ≥ 50 kg.
- Fasting plasma glucose of 1 year post-menopausal, surgically sterile, or practicing a clinically acceptable form of birth control and confirmed by negative serum pregnancy test at Screening.
Exclusion Criteria
- History of diabetes mellitus.
- Resting blood pressure (BP) > 140/90 mmHg or 450 ms in men, > 470 ms in women at Screening.
- Liver function test results of AST and/or ALT ≥ 2.5 upper normal limit (ULN)
- Subject has a history of syncope.
- History of any major surgery within 6 months.
- History of any active infection, other than mild viral illness within 30 days prior to dosing.
- History of blood clots (e.g., deep vein thrombosis or embolism) or a frequent appearance in 1st degree relatives as judged by the Investigator.
- Known history or positive test of hepatitis B surface antigen (HBsAG), hepatitis C antibody (HCV Ab), or human immunodeficiency virus type 1 (HIV-1) or 2 (HIV-2) antibody.
- History of alcohol abuse as judged by the Investigator within approximately 1 year. Average weekly alcohol intake > 21 units/week (males) and > 14 units/week (females) or are unwilling to stop alcohol consumption from 24 hours prior to each dosing until discharged from the clinical research unit (CRU). Positive alcohol test at Screening. (One unit of alcohol equals about 250 mL of beer or lager, one glass of wine, or 20 mL of spirits).
- History of illicit drug abuse, including marijuana, within approximately 1 year or evidence of current use as judged by the Investigator. Positive drug test at Screening.
- Donation or loss of > 500 mL of blood within 56 days.
- Chronic use of over-the-counter or prescription medication within 7 or 14 days prior to dosing (apart from vitamin/mineral supplements, occasional paracetamol, or birth control methods [Desogestrel is not allowed]).
- Unable to comply with the safety monitoring requirements of this clinical study or is considered by the investigator to be an unsuitable candidate for the study.
Data sourced from ClinicalTrials.gov (NCT05539872). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.