Comparison of the Pharmacokinetics (PK) and Pharmacodynamics (PD) Biosimilarity of Proposed Biosimilar/Interchangeable Rapid-Acting Insulin Aspart (I004) and NovoLog® After Single-Dose Subcutaneous Administration to Healthy Volunteers

Part of paid clinical trials in Chula Vista, California.

Sponsor
Amphastar Pharmaceuticals, Inc.
Study ID
NCT07560150
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Insulin Aspart
  • Pharmacodynamics
  • Pharmacokinetics

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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 pharmacodynamic (PD) biosimilarity of proposed biosimilar I004 and the US-approved NovoLog.

Key Dates

Start date
Apr 6, 2026
Status verified
Apr 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Insulin Aspart, I004
    Participants who were dosed with I004
  • Active Comparator: NovoLog
    Participants who were dosed with NovoLog

Primary Outcome Measure

Maximum Serum Insulin Aspart Concentration, CIAmax [ Time Frame: Baseline (Time 0) to 12 hours post-dose ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Amphastar Study SiteChula VistaCalifornia91911
Amphastar Pharmaceuticals, Inc.
[email protected]
909-980-9484

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Amphastar Study Site· Chula Vista, CA

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