HealthyPhase 1NCT05373186
A Trial Investigating the Pharmacodynamics of BC Combo THDB0207 Compared With Humalog® Mix25 and Simultaneous Injections of Humalog® and Lantus® in Healthy Chinese Volunteers
A Phase 1 study testing Euglycemic clamp with BC Combo THDB0207, Euglycemic clamp with Humalog® Mix25 and Euglycemic clamp with Humalog® and Lantus® in people with Healthy, run by Adocia at 1 site in Germany.
Trial summary
This is a randomised, double-blind, double-dummy, active-controlled, three-period crossover euglycemic clamp trial in healthy Chinese volunteers. Each subject will be randomly allocated to one of 6 treatment sequences. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Euglycemic clamp with BC Combo THDB0207, Euglycemic clamp with Humalog® Mix25 and Euglycemic clamp with Humalog® and Lantus®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteGermany
- Study dates
- 12 May 2022to 4 Dec 2022
- 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 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects with Chinese origin. To qualify as a subject of Chinese origin (first-generation Chinese), the subject, the subject's biological parents, and all of the subject's biological grandparents are of exclusive Chinese descent and have been born in China.
- BMI between 18.5 and 30.0 kg/m2, both inclusive.
- Fasting plasma glucose concentration <= 5.6 mmol/L (100 mg/dL).
Who cannot join
- Known or suspected hypersensitivity to IMP(s) or any of the excipients or to any component of the IMP formulation.
- Receipt of any investigational medicinal product within 3 months before randomisation in this trial.
- Women of childbearing potential who are not using a highly effective contraceptive method.
- 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.
- Heart rate at rest outside the range of 50-90 beats per minute.
- 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
This is a randomised, double-blind, double-dummy, active-controlled, three-period crossover euglycemic clamp trial in healthy Chinese volunteers.
Each subject will be randomly allocated to one of 6 treatment sequences. Each sequence comprises one single dose of BC Combo THDB0207, one single dose of Humalog® Mix25, or simultaneous administration of Humalog® and Lantus®.
Subjects will come in a fasted state to the clinical trial centre in the morning of each dosing day and stay at the clinical trial centre until the 30-hour clamp procedures have been terminated.
Read the detailed description
Subjects will attend the study site in the morning in a fasted state and will be connected to an automated glucose clamp device (ClampArt). Prior to dose administration plasma glucose will be stabilised at a defined target level by means of an intravenous infusion of glucose or insulin. IMP administration will be done by an unblinded person by means of subcutaneous injections in the abdominal wall.
Following each dosing a euglycaemic glucose clamp procedure will be carried out for up to 30 hours.
The pharmacodynamic assessment will be based on the time course of glucose infusion rate (GIR) and plasma glucose.
Plasma insulin concentrations will be measured using a specific validated bioanalytical method differentiating concentrations of insulin glargine, of its main metabolites insulin-glargine-M1 and insulin-glargine M2, and of insulin lispro. Pharmacokinetic insulin assessments will be based on total insulin concentration.
- Conditions
- Healthy
- Being tested
- Euglycemic clamp with BC Combo THDB0207, Euglycemic clamp with Humalog® Mix25, Euglycemic clamp with Humalog® and Lantus®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Euglycemic clamp with BC Combo THDB0207Drug
Administration of a single dose of BC Combo THDB0207 during an euglycemic clamp procedure
Euglycemic clamp with Humalog® Mix25Drug
Administration of a single dose of Humalog® Mix25 during an euglycemic clamp procedure
Euglycemic clamp with Humalog® and Lantus®Drug
Simultaneous administration of Humalog® and Lantus® during an euglycemic clamp procedure
| Study group | Role | What they receive |
|---|---|---|
| BC Combo THDB0207 | Experimental | Single administration of BC Combo THDB0207 Receives: Drug: Euglycemic clamp with BC Combo THDB0207 |
| Humalog® Mix25 | Active comparator | Single administration of Humalog® Mix25 Receives: Drug: Euglycemic clamp with Humalog® Mix25 |
| Humalog® and Lantus® | Active comparator | Simultaneous administration of Humalog® and Lantus® Receives: Drug: Euglycemic clamp with Humalog® and Lantus® |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCGIR 0-2h
Area under the glucose infusion rate curve until 2 hours after IMP dosing
Measured: From t=0 to t=2 hours after IMP administration
Secondary outcomes (19)
AUCGIR 0-last
Area under the glucose infusion rate curve from 0 hours until the end of clamp
Measured: From t=0 to t= 30 hours after IMP administration
GIRmax
Maximum Glucose Infusion Rate
Measured: From t=0 to t= 30 hours after IMP administration
AUCGIR 0-1h
Area under the glucose infusion rate curve until 1 hour after IMP dosing
Measured: From t=0 to t=1 hours after IMP administration
AUCGIR 0-6h
Area under the glucose infusion rate curve until 6 hours after IMP dosing
Measured: From t=0 to t=6 hours after IMP administration
AUCGIR 0-24h
Area under the glucose infusion rate curve until 24 hours after IMP dosing
Measured: From t=0 to t=24 hours after IMP administration
tGIRmax
Time to maximum glucose infusion rate
Measured: From t=0 to t=30 hours after IMP administration
tonset of action
Time until plasma glucose (PG) has decreased by at least 5 mg/dL from the baseline PG value
Measured: From t=0 to t=30 hours after IMP administration
AUCINSlast
Area under the insulin concentration-time curve from t=0 to the last measured insulin concentration above LLOQ
Measured: From t=0 to t=30 hours after IMP administration
AUCINS 0-2h
Area under the insulin concentration-time curve during from t=0 to t=2h
Measured: From t=0 to t=2 hours after IMP administration
AUCINS 0-6h
Area under the insulin concentration-time curve during from t=0 to t=6h
Measured: From t=0 to t=6 hours after IMP administration
AUCINS 2-4h
Area under the insulin concentration-time curve during from t=2 to t=4h
Measured: From t=2 to t=4 hours after IMP administration
AUCINS 6-12h
Area under the insulin concentration-time curve during from t=6 to t=12h
Measured: From t=6 to t=12 hours after IMP administration
AUCINS 12-30h
Area under the insulin concentration-time curve during from t=12 to t=30h
Measured: From t=12 to t=30 hours after IMP administration
AUCINS 0-30h
Area under the insulin concentration-time curve during from t=0 to t=30h
Measured: From t=0 to t=30 hours after IMP administration
CmaxINS
Maximum insulin concentration
Measured: From t=0 to t= 30 hours after IMP administration
Tonset ins
Tonset of insulin appearance
Measured: From t=0 to t=30 hours
Adverse Events
Incidence of adverse events
Measured: From the first IMP administration to the follow-up visit (i.e. up to 11 weeks)
Serious Adverse Events
Incidence of Serious Adverse Events
Measured: From the first IMP administration to the follow-up visit (i.e. up to 11 weeks)
Local tolerability
Incidence of injection site reactions
Measured: From the first IMP administration to the follow-up visit (i.e. up to 11 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2022
- Study start12 May 2022
- Primary completion4 Dec 2022
- Study completion4 Dec 2022
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
- Model description
- Three-period crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adocia
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tonghua Dongbao Pharmaceutical Co.,Ltd
- Responsible party
- Sponsor
- Investigators
- Oliver Klein, MD, Principal investigator, Profil Institut für Stoffwechselforschung GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05373186
- Sponsor's protocol ID
- CT046-ADO05
- Status last verified
- Oct 2023
- First submitted
- 4 May 2022
- Last updated
- 12 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial Investigating the Pharmacodynamics of BC Combo THDB0207 Compared With Humalog® Mix25 and Simultaneous Injections of Humalog® and Lantus® in Healthy Chinese Volunteers
- ClinicalTrials.gov ID
- NCT05373186
- Acronym / sponsor ID
- CT046-ADO05
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- AdociaIndustry (pharma, biotech, devices)
- Collaborators
- Tonghua Dongbao Pharmaceutical Co.,Ltd
- Study start
- 12 May 2022 (actual)
- Primary completion
- 4 Dec 2022 (actual)
- Study completion
- 4 Dec 2022 (actual)
- First posted
- 13 May 2022 (actual)
- 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 randomised, double-blind, double-dummy, active-controlled, three-period crossover euglycemic clamp trial in healthy Chinese volunteers.
Each subject will be randomly allocated to one of 6 treatment sequences. Each sequence comprises one single dose of BC Combo THDB0207, one single dose of Humalog® Mix25, or simultaneous administration of Humalog® and Lantus®.
Subjects will come in a fasted state to the clinical trial centre in the morning of each dosing day and stay at the clinical trial centre until the 30-hour clamp procedures have been terminated.
Detailed description
Subjects will attend the study site in the morning in a fasted state and will be connected to an automated glucose clamp device (ClampArt). Prior to dose administration plasma glucose will be stabilised at a defined target level by means of an intravenous infusion of glucose or insulin. IMP administration will be done by an unblinded person by means of subcutaneous injections in the abdominal wall.
Following each dosing a euglycaemic glucose clamp procedure will be carried out for up to 30 hours.
The pharmacodynamic assessment will be based on the time course of glucose infusion rate (GIR) and plasma glucose.
Plasma insulin concentrations will be measured using a specific validated bioanalytical method differentiating concentrations of insulin glargine, of its main metabolites insulin-glargine-M1 and insulin-glargine M2, and of insulin lispro. Pharmacokinetic insulin assessments will be based on total insulin concentration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Three-period crossover
| Arm | Type | Receives |
|---|---|---|
| BC Combo THDB0207 | Experimental | Drug: Euglycemic clamp with BC Combo THDB0207Single administration of BC Combo THDB0207 |
| Humalog® Mix25 | Active comparator | Drug: Euglycemic clamp with Humalog® Mix25Single administration of Humalog® Mix25 |
| Humalog® and Lantus® | Active comparator | Drug: Euglycemic clamp with Humalog® and Lantus®Simultaneous administration of Humalog® and Lantus® |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subjects with Chinese origin. To qualify as a subject of Chinese origin (first-generation Chinese), the subject, the subject's biological parents, and all of the subject's biological grandparents are of exclusive Chinese descent and have been born in China.
- BMI between 18.5 and 30.0 kg/m2, both inclusive.
- Fasting plasma glucose concentration <= 5.6 mmol/L (100 mg/dL).
Key exclusion criteria (6 listed)
- Known or suspected hypersensitivity to IMP(s) or any of the excipients or to any component of the IMP formulation.
- Receipt of any investigational medicinal product within 3 months before randomisation in this trial.
- Women of childbearing potential who are not using a highly effective contraceptive method.
- 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.
- Heart rate at rest outside the range of 50-90 beats per minute.
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 |
|---|---|---|
| Euglycemic clamp with BC Combo THDB0207Administration of a single dose of BC Combo THDB0207 during an euglycemic clamp procedure | Drug | BC Combo THDB0207 |
| Euglycemic clamp with Humalog® Mix25Administration of a single dose of Humalog® Mix25 during an euglycemic clamp procedure | Drug | Humalog® Mix25 |
| Euglycemic clamp with Humalog® and Lantus®Simultaneous administration of Humalog® and Lantus® during an euglycemic clamp procedure | Drug | Humalog® and Lantus® |
Primary outcome
AUCGIR 0-2h
Time frame: From t=0 to t=2 hours after IMP administration
Area under the glucose infusion rate curve until 2 hours after IMP dosing
19 secondary outcomes
AUCGIR 0-last
Time frame: From t=0 to t= 30 hours after IMP administration
GIRmax
Time frame: From t=0 to t= 30 hours after IMP administration
AUCGIR 0-1h
Time frame: From t=0 to t=1 hours after IMP administration
AUCGIR 0-6h
Time frame: From t=0 to t=6 hours after IMP administration
AUCGIR 0-24h
Time frame: From t=0 to t=24 hours after IMP administration
tGIRmax
Time frame: From t=0 to t=30 hours after IMP administration
tonset of action
Time frame: From t=0 to t=30 hours after IMP administration
AUCINSlast
Time frame: From t=0 to t=30 hours after IMP administration
AUCINS 0-2h
Time frame: From t=0 to t=2 hours after IMP administration
AUCINS 0-6h
Time frame: From t=0 to t=6 hours after IMP administration
AUCINS 2-4h
Time frame: From t=2 to t=4 hours after IMP administration
AUCINS 6-12h
Time frame: From t=6 to t=12 hours after IMP administration
AUCINS 12-30h
Time frame: From t=12 to t=30 hours after IMP administration
AUCINS 0-30h
Time frame: From t=0 to t=30 hours after IMP administration
CmaxINS
Time frame: From t=0 to t= 30 hours after IMP administration
Tonset ins
Time frame: From t=0 to t=30 hours
Adverse Events
Time frame: From the first IMP administration to the follow-up visit (i.e. up to 11 weeks)
Serious Adverse Events
Time frame: From the first IMP administration to the follow-up visit (i.e. up to 11 weeks)
Local tolerability
Time frame: From the first IMP administration to the follow-up visit (i.e. up to 11 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 12 Oct 2023.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Oliver Klein, MD principal investigator
Profil Institut für Stoffwechselforschung 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 Euglycemic clamp with BC Combo THDB0207, Euglycemic clamp with Humalog® Mix25 and Euglycemic clamp with Humalog® and Lantus® 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 3 inclusion and 6 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 12 Oct 2023. 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?
AUCGIR 0-2h (time frame: From t=0 to t=2 hours after IMP administration). 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 12 Oct 2023.