A Pilot Clinical Trial Investigating the Intra-subject Variability of Pharmacokinetics and Glucodynamics of BioChaperone Insulin Lispro U-100 Product (2 Single Doses of 0.2 U/kg) and U-200 Product (2 Single Doses of 0.2 U/kg) in Healthy Male and Female
Overview
- Phase
- Phase 1
- Intervention
- BioChaperone Lispro U-100
- Conditions
- Healthy
- Sponsor
- Adocia
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Cmax Lisp
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
This is a double-blinded, randomised, single-centre phase I pilot trial for exploring the feasibility of a pivotal clinical trial establishing bioequivalence between BioChaperone insulin lispro U-200 and BioChaperone insulin lispro U-100 in healthy subjects.
Each subject will be randomly allocated to a sequence of four treatments, i.e. two single doses of BioChaperone insulin lispro U-200 of 0.2 U·kg BW-1 and two single doses of BioChaperone insulin lispro U-100 of 0.2 U·kg BW-1 on four separate dosing visits.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female subjects, considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the Investigator.
- •Age ≥ 18 and ≤ 64 years, both inclusive.
- •Body Mass Index (BMI) between 18.5 and 28.0 kg∙m-2, both inclusive.
- •Fasting Plasma Glucose (FPG) ≤ 5.6 mmol/L (100 mg/dL).
- •Signed and dated informed consent obtained before any trial-related activities, i.e. any procedures that would not have been performed during normal management of the subject).
Exclusion Criteria
- •Known or suspected hypersensitivity to trial product(s) or related products.
- •Receipt of any investigational medicinal product within 3 months before randomisation in this trial.
Arms & Interventions
BioChaperone Lispro U-100
injection of 2 doses of 0.2 U/kg on separate visits
Intervention: BioChaperone Lispro U-100
BioChaperone Lispro U-200
injection of 2 doses of 0.2 U/kg on separate visits
Intervention: BioChaperone Lispro U-200
Outcomes
Primary Outcomes
Cmax Lisp
Time Frame: 8 hours
Maximum observed insulin lispro serum concentration
AUCLisp (0-inf)
Time Frame: 8 hours
Area under the insulin lispro serum concentration - time curve from t=0 to infinity
Secondary Outcomes
- tmax Lisp(8 hours)
- AUCGIR(0-8h)(8 hours)
- Number of Adverse events(Up to 9 weeks)
- Local tolerability(Up to 9 weeks)
- GIRmax(8 hours)
- tGIRmax(8 hours)