Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
I004 · 1 trial · 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 product developed by Amphastar Pharmaceuticals, Inc. (ticker AMPH). It is being studied as a proposed biosimilar and interchangeable version of NovoLog, a rapid-acting insulin used to manage blood glucose. I004 is in Phase 2 clinical development and has been evaluated in a completed pharmacokinetic and pharmacodynamic study.
I004 is being developed as a rapid-acting insulin aspart for glycemic control, the same therapeutic use as NovoLog. Its completed Phase 2 trial enrolled healthy adult volunteers to compare pharmacokinetics and pharmacodynamics rather than to test glucose-lowering outcomes in patients with diabetes. The program targets the metabolic therapeutic area.
I004 is developed by Amphastar Pharmaceuticals, Inc., which trades under the ticker AMPH. The company is advancing I004 as a proposed biosimilar and interchangeable rapid-acting insulin aspart product.
I004 is in Phase 2 clinical development. One Phase 2 trial has been completed, and no trials are currently active. The completed study was a randomized, double-blind, active-controlled comparison conducted in the United States.
I004 has been studied in one completed Phase 2 trial, NCT07560150. That trial compared the pharmacokinetics and pharmacodynamics of I004 with NovoLog after a single subcutaneous dose in healthy volunteers. It enrolled 62 participants aged 18 years and older, was randomized, double-blind, and active-controlled, and was conducted in the United States.
I004 is not approved; it is an investigational product still in clinical development. Its only listed trial, NCT07560150, has completed, and no active trials are ongoing. Amphastar Pharmaceuticals is developing it as a proposed biosimilar and interchangeable rapid-acting insulin aspart.