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An Euglycemic Clamp Trial to Evaluate Pharmacokinetics of Single Doses of BioChaperone Insulin Lispro in Healthy Japanese Subjects

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Adocia

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: Biochaperone insulin lispro 0.4 U/kg
Drug: Biochaperone insulin lispro 0.2 U/kg
Drug: Humalog®
Drug: Biochaperone insulin lispro 0.1 U/kg

Study type

Interventional

Funder types

Industry

Identifiers

NCT02660502
BC3-CT017

Details and patient eligibility

About

This is a double-blind, randomised, three period crossover phase 1 trial using automated 8-hour euglycemic clamps in healthy Japanese subjects.

Each subject will be randomly allocated to one out of nine sequences to receive either three single doses of BioChaperone insulin lispro or one single dose of Humalog® and two single doses of BioChaperone insulin lispro on three separate dosing visits.

The total trial maximum duration for a subject will be up to 10 weeks.

Enrollment

15 patients

Sex

All

Ages

20 to 64 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy Japanese male or female subjects by completion of medical history, physical examination and biochemical investigations as judged by the Investigator.
  • BMI between 18.5 and 25.0 kg∙m-2, both inclusive.
  • Fasting Plasma Glucose ≤ 5.6 mmol/L (100 mg/dL).
  • Signed and dated informed consent obtained before any trial-related activities.

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.
  • Any history or presence of a life threatening disease (i.e. cancer except basal cell skin cancer or squamous cell skin cancer), or of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic (including type 1 and type 2 diabetes mellitus, haematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynaecologic (if female), or infectious disease, or signs of acute illness as judged by the investigator.
  • History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

15 participants in 4 patient groups

BioChaperone insulin lispro 0.1 U/kg
Experimental group
Treatment:
Drug: Biochaperone insulin lispro 0.1 U/kg
BioChaperone insulin lispro 0.2 U/kg
Experimental group
Treatment:
Drug: Biochaperone insulin lispro 0.2 U/kg
BioChaperone insulin lispro 0.4 U/kg
Experimental group
Treatment:
Drug: Biochaperone insulin lispro 0.4 U/kg
Humalog®
Active Comparator group
Treatment:
Drug: Humalog®

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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