HealthyPhase 1NCT02660502
An Euglycemic Clamp Trial to Evaluate Pharmacokinetics of Single Doses of BioChaperone Insulin Lispro in Healthy Japanese Subjects
A Phase 1 study testing Biochaperone insulin lispro 0.1 U/kg, Biochaperone insulin lispro 0.2 U/kg and Biochaperone insulin lispro 0.4 U/kg in people with Healthy, run by Adocia at 1 site in Germany.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Biochaperone insulin lispro 0.1 U/kg, Biochaperone insulin lispro 0.2 U/kg and Biochaperone insulin lispro 0.4 U/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2016to May 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Comparator-controlled, Randomised, Three-period Crossover Euglycemic Clamp Trial to Evaluate Pharmacokinetics of Single Doses of BioChaperone Insulin Lispro in Healthy Japanese Subjects
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.
- Conditions
- Healthy
- Being tested
- Biochaperone insulin lispro 0.1 U/kg, Biochaperone insulin lispro 0.2 U/kg, Biochaperone insulin lispro 0.4 U/kg, Humalog®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biochaperone insulin lispro 0.1 U/kgDrug
Injection of a single dose of BioChaperone insulin lispro at the dose of 0.1 U/kg
Biochaperone insulin lispro 0.2 U/kgDrug
Injection of a single dose of BioChaperone insulin lispro at the dose of 0.2 U/kg
Biochaperone insulin lispro 0.4 U/kgDrug
Injection of a single dose of BioChaperone insulin lispro at the dose of 0.4 U/kg
Humalog®Drug
Injection of a single dose of Humalog® at the dose of 0.2 U/kg
| Study group | Role | What they receive |
|---|---|---|
| BioChaperone insulin lispro 0.1 U/kg | Experimental | Not described Receives: Drug: Biochaperone insulin lispro 0.1 U/kg |
| BioChaperone insulin lispro 0.2 U/kg | Experimental | Not described Receives: Drug: Biochaperone insulin lispro 0.2 U/kg |
| BioChaperone insulin lispro 0.4 U/kg | Experimental | Not described Receives: Drug: Biochaperone insulin lispro 0.4 U/kg |
| Humalog® | Active comparator | Not described Receives: Drug: Humalog® |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCLispro(0-30min)
Area under the insulin lispro serum concentration - time curve from t=0 to 30 minutes
Measured: Up to 30 minutes
Secondary outcomes (2)
AUCGIR(0-last)
Area under the glucose infusion rate time curve from 0 hours until the end of clamp
Measured: Up to 8 hours
Adverse Events
Number of adverse events
Measured: Up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adocia
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- Grit Andersen, MD, Principal investigator, Profil GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02660502
- Sponsor's protocol ID
- BC3-CT017
- Status last verified
- Jan 2016
- First submitted
- 18 Jan 2016
- Last updated
- 30 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Comparator-controlled, Randomised, Three-period Crossover Euglycemic Clamp Trial to Evaluate Pharmacokinetics of Single Doses of BioChaperone Insulin Lispro in Healthy Japanese Subjects
- ClinicalTrials.gov ID
- NCT02660502
- Acronym / sponsor ID
- BC3-CT017
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- AdociaIndustry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Study start
- Jan 2016
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 21 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BioChaperone insulin lispro 0.1 U/kg | Experimental | Drug: Biochaperone insulin lispro 0.1 U/kg |
| BioChaperone insulin lispro 0.2 U/kg | Experimental | Drug: Biochaperone insulin lispro 0.2 U/kg |
| BioChaperone insulin lispro 0.4 U/kg | Experimental | Drug: Biochaperone insulin lispro 0.4 U/kg |
| Humalog® | Active comparator | Drug: Humalog® |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biochaperone insulin lispro 0.1 U/kgInjection of a single dose of BioChaperone insulin lispro at the dose of 0.1 U/kg | Drug | BioChaperone insulin lispro 0.1 U/kg |
| Biochaperone insulin lispro 0.2 U/kgInjection of a single dose of BioChaperone insulin lispro at the dose of 0.2 U/kg | Drug | BioChaperone insulin lispro 0.2 U/kg |
| Biochaperone insulin lispro 0.4 U/kgInjection of a single dose of BioChaperone insulin lispro at the dose of 0.4 U/kg | Drug | BioChaperone insulin lispro 0.4 U/kg |
| Humalog®Injection of a single dose of Humalog® at the dose of 0.2 U/kg | Drug | Humalog® |
Primary outcome
AUCLispro(0-30min)
Time frame: Up to 30 minutes
Area under the insulin lispro serum concentration - time curve from t=0 to 30 minutes
2 secondary outcomes
AUCGIR(0-last)
Time frame: Up to 8 hours
Adverse Events
Time frame: Up to 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grit Andersen, MD principal investigator
Profil GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Biochaperone insulin lispro 0.1 U/kg, Biochaperone insulin lispro 0.2 U/kg and Biochaperone insulin lispro 0.4 U/kg in people with Healthy, run by Adocia at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUCLispro(0-30min) (time frame: Up to 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2016.