Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
I004 · 2 trials · 3 indications
Pharmacokinetic (PK) blood samples will be collected from 60 minutes before dose through 12 hours post-dose. Serum will be isolated for analyzing the concentrations of Insulin Aspart
Pharmacokinetic (PK) blood samples will be collected from 60 minutes before dose through 12 hours post-dose. Serum will be isolated for analyzing the concentrations of Insulin Aspart. AUCIA(0-12h) will be calculated from the concentration curves. Only AUC from 0 to 12 hours (AUCIA(0-12h)) is reported.
Participants will undergo a euglycemic clamp, where blood glucose concentration will be held at a constant target level by adjusting exogenous glucose infusion rate (GIR) following drug administration. GIR will be recorded for the duration of the euglycemic clamp and used to evaluate the Pharmacodynamic (PD) response.
Participants will undergo a euglycemic clamp, where blood glucose concentration will be held at a constant target level by adjusting exogenous glucose infusion rate (GIR) following drug administration. GIR will be recorded for the duration of the euglycemic clamp and used to evaluate the Pharmacodynamic (PD) response. AUCG(0-12h) will be calculated from the glucose infusion rate curves. Because GIR is recorded in mg/kg/min, the area under the GIR-time curve has units mg/kg.
| Arm | Type | Description |
|---|---|---|
| Insulin Aspart, I004 | EXPERIMENTAL | Participants who were dosed with I004 |
| NovoLog | ACTIVE_COMPARATOR | Participants who were dosed with NovoLog |
| Name | Type | Description |
|---|---|---|
| I004 | DRUG | Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Day -1 of Treatment Period 1 under fasting condition. |
| NovoLog | DRUG | Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Day -1 of Treatment Period 1 under fasting condition. |
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 \< 100 mg/dL (5.5 mmol/L) measured with YSI at site; one repe...
I004 is an investigational rapid-acting insulin aspart biosimilar being studied for pharmacokinetics and pharmacodynamics. It is intended to be comparable to NovoLog, a rapid-acting insulin aspart. The drug is being evaluated in healthy volunteers to assess its biosimilarity to the reference product.
I004 is being developed by Amphastar Pharmaceuticals, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol AMPH. The company is conducting clinical trials to evaluate the drug's pharmacokinetic and pharmacodynamic profile as a proposed biosimilar to NovoLog.
I004 is in Phase 2 clinical development. Two Phase 2 trials have been completed, both focusing on pharmacokinetics and pharmacodynamics in healthy volunteers. The drug is investigational and has not been approved by regulatory authorities.
I004 has been studied in two completed Phase 2 trials: NCT05539872 and NCT07560150. Both trials compared the pharmacokinetics and pharmacodynamics of I004 to NovoLog after single-dose subcutaneous administration in healthy volunteers. The trials were conducted in the United States with a combined enrollment of 131 participants.
I004 is not the same as NovoLog, but it is being developed as a proposed biosimilar to NovoLog, which is a rapid-acting insulin aspart. The clinical trials for I004 are designed to demonstrate biosimilarity in pharmacokinetics and pharmacodynamics between the two products.
I004 is a rapid-acting insulin aspart, a form of insulin that works by replacing the insulin normally produced by the body to help regulate blood sugar levels. As a biosimilar to NovoLog, it is designed to have a similar mechanism of action, providing rapid glucose-lowering effects after subcutaneous injection.