Actively Recruiting
Comparison of the Pharmacokinetics and Pharmacodynamics Biosimilarity of Proposed Biosimilar Rapid-Acting Insulin Aspart (I004) and NovoLog After Single-Dose Subcutaneous Injection in Healthy Volunteers: A Randomized, Double-Blinded, Two-Treatment, Two-Period, Two-Sequence Crossover Study
Led by Amphastar Pharmaceuticals, Inc. · Updated on 2026-04-30
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the pharmacokinetic (PK) and pharmacodynamic (PD) biosimilarity between a proposed biosimilar rapid-acting insulin aspart called I004 and the US-approved NovoLog. This randomized, double-blinded, two-treatment, two-period, two-sequence crossover pivotal study aims to compare these insulin products in healthy volunteers to establish if I004 behaves similarly to NovoLog after a single dose. Participants receive subcutaneous injections of either I004 or NovoLog at a dose of 0.2 units/kg based on their body weight measured the day before treatment. The study uses a crossover design where participants receive both treatments in separate periods under fasting conditions. This design helps compare the pharmacological effects of the two insulin formulations directly within the same individuals. During the study, researchers will monitor serum insulin aspart concentrations and glucose infusion rates over a 12-hour period following dosing. Various measurements include maximum insulin levels, area under the concentration curve, and glucose infusion rates assessing how the body responds to insulin. Safety assessments and monitoring occur throughout the trial, which includes healthy adult volunteers aged 18 to 65 years. The study is sponsored by Amphastar Pharmaceuticals, Inc. and is expected to complete by June 2026.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Agree to participate and sign informed consent
- Healthy males and females aged 18 to 65 years
- Body mass index (BMI) between 18.5 and 29.9 kg/m2
- Weight of at least 50 kg
- Fasting plasma glucose less than 100 mg/dL
- HbA1c less than 5.7%
- Non-smoker for at least 3 months prior to screening
- Female participants must be more than 1 year post-menopausal, surgically sterile, or practicing an approved form of birth control with a negative pregnancy test at screening
You will not qualify if you...
- History of diabetes mellitus
- Resting blood pressure above 140/90 mmHg or below 90/60 mmHg
- Participation in other investigational drug or device studies within 30 days or 5 half-lives of last dose
- History of serious adverse reaction or allergy to study product components
- Significant current or past cardiovascular, respiratory, liver, kidney, gastrointestinal, endocrine, blood, neurological, or systemic disease
- Active neuropsychiatric disease or use of related prescription medications
- Clinically significant abnormal physical, lab, or ECG findings
- Long QT syndrome or family history of long QT syndrome
- Elevated liver enzymes (AST or ALT above 2.5 times normal)
- History of fainting (syncope)
- Major surgery within last 6 months
- Active infection other than mild viral illness within 30 days prior to dosing
- History of blood clots or family history judged significant
- Positive test or history of hepatitis B, hepatitis C, or HIV
- Systemic glucocorticoid use within 3 months before screening
- History of alcohol abuse or exceeding set weekly alcohol intake limits
- History of illicit drug use within 1 year or positive drug test
- Blood donation or loss over 500 mL within 56 days
- Chronic use of medications within 7 or 14 days prior to dosing except certain supplements
- Inability to comply with safety monitoring or unsuitable for study
- Women who are pregnant or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Two treatment periods with single-dose injections, each followed by 12 hours of monitoring
Participants receive a single subcutaneous injection of either the proposed biosimilar rapid-acting insulin aspart (I004) or NovoLog under fasting conditions, with crossover to the other treatment after a washout period.
2 treatment visits (in-person) with 12 hours post-dose monitoring each
Trial Site Locations
Total: 1 location
1
Amphastar Study Site
Chula Vista, California, United States, 91911
Actively Recruiting
Research Team
A
Amphastar Pharmaceuticals, Inc.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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