CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 69 enrolled
Drug / intervention
I004 +1 moredrug
Likely dose
I004 0.2 unitsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05539872
NCT05539872Phase 3Completed
CompareCT.gov

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: A Single-Center Randomized, Double-blinded, Two-Treatment, Two-period, Two-sequence Crossover, Hyperinsulinemia-Euglycemic Clamp

Amphastar Pharmaceuticals, Inc.·interventional·Posted Sep 14, 2022·Updated Mar 5, 2026

In Brief

A Phase 3 clinical trial evaluating I004 and NovoLog for Pharmacokinetics and Pharmacodynamics. Completed, enrolled 69 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPharmacokinetics, Pharmacodynamics
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2023202420252026
First PostedSep 14, 2022
Enrollment StartAug 22, 2022
Primary CompletionJan 29, 2023
Study CompletionJan 30, 2023
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 3.8 years ago

Interventions

I004drug

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 Treatment Period 1 under fasting condition.

NovoLogdrug

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 Treatment Period 1 under fasting condition.