HealthyPhase 1NCT06153329
A Trial to Evaluate the Pharmacokinetics and Pharmacodynamics of THDB0206 Injection in Healthy Chinese Subjects
A Phase 1 study testing THDB0206 injection, Humalog® and BC222insulin lispro injection in people with Healthy, run by Tonghua Dongbao Pharmaceutical Co.,Ltd at 1 site in China.
Trial summary
This is a single-center, single-dose, open-label, positive-controlled, randomized, three-cycle, crossover 8-hour euglycemic clamp study to evaluate the PK, PD, safety and tolerability of THDB0206 injection after subcutaneous injection in healthy Chinese subjects. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- THDB0206 injection, Humalog® and BC222insulin lispro injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteChina
- Study dates
- 17 Jun 2021to 6 Jun 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects who provide a signed and dated informed consent form (Appendix 1) before starting any study-related activities (study-related activities are any procedures that will not be involved during the normal management of subjects).
- Healthy local Chinese males or females, who complete medical history, physical examination and laboratory tests according to the judgment of the investigator.
- Aged ≥ 18 years and ≤ 40 years when signing the informed consent form.
- Body mass index (BMI) ≥ 18 kg/m2 and < 25 kg/m2 at screening, male weight ≥ 50 kg, female weight ≥ 45 kg.
- Intravenous fasting blood glucose < 6.1 mmol/L and intravenous blood glucose < 7.8 mmol/L 2 hours after the glucose load in the 75 g oral glucose tolerance test at screening.
- According to local laboratory analysis, glycated hemoglobin HbA1c≤6.1% st screening.
Who cannot join
- Subjects who meet any of the following criteria will be excluded from the study:
- Known or suspected allergies to investigational medicinal products and related products, or a history of multiple and/or severe allergies to drugs or food.
- Subjects who have previously participated in this study (participation in the study is defined as randomization), or received any drugs in the clinical development stage within 3 months before the screening of this study.
- Any cancer or history of cancer, including basal cell skin cancer or squamous cell skin cancer.
- According to the judgment of the investigator, any clinically relevant cardiovascular, respiratory, gastrointestinal, liver, kidney, metabolism, endocrine, hematology (bleeding diseases), skin, venereal disease, nervous system, mental disease or other major diseases or related medical history.
- During the screening visit, abnormal values of hematology, blood biochemistry, blood coagulation or urinalysis have clinical significance, and the investigator judges and considers potential diseases.
Show all 24Show fewer
- According to the judgment of the investigator, the results of the insulin release test has clinically significant abnormalities at screening.
- Heart problems, defined as the presence of decompensated heart failure (New York Heart Association Class III and IV) at any time and/or angina pectoris within 12 months prior to screening and/or acute myocardial infarction at any time.
- According to the judgment of the investigator, the blood pressure has clinically significant abnormalities at screening.
- The heart rate detected by 12-lead ECG at rest exceeds the range of 50-100 beats per minute (including 50 and 100 beats).
- According to the judgment of the investigator, the standard 12-lead ECG has clinically significant abnormalities at screening.
- Increased risk of thromboembolism, such as known coagulopathy, (family) history of thrombosis, related arrhythmias (e.g., paroxysmal atrial fibrillation), etc.
- Mental disorders or language barriers which prevent full understanding or cooperation.
- According to the investigator's judgment, there is a history of deep vein thrombosis in the lower extremities or a first-degree relative (parents, siblings or children) frequently develops deep vein thrombosis in the lower extremities.
- Any disease or condition that the investigator believes will pose an unacceptable risk to the safety of the subjects.
- Subjects who have used any drugs (prescription drugs and over-the-counter drugs) within 14 days before administration of the IMP or within 5 times the elimination half-life of the IMP (whichever is longer).
- According to the investigator's judgment, subjects with a history of alcoholism or drug/chemical drug abuse, or subjects with positive drug screening/breath alcohol test results during the screening visit, or subjects drinking more than 21 units of alcohol per week (male subjects) or 14 units of alcohol (female subjects) (1 unit of alcohol is equivalent to approximately 330 mL of beer, 1 glass of 120 mL of wine or 40 mL of spirits).
- Subjects who have smoked more than 5 cigarettes per day on average within one year before the screening visit and do not agree to quit smoking during the study period.
- Female subjects who have a positive pregnancy test result during the screening visit or on Day -1 of Visit 2.
- According to the diagnostic test used locally, hepatitis B surface antigen or hepatitis C antibody is positive (or active hepatitis is diagnosed according to local practice), or human immunodeficiency virus (HIV) antibody test result is positive, or syphilis test result is positive.
- Subjects who have donated blood or plasma in the past month, or donated more than 300 mL within 3 months before the screening visit.
- During the period from the first administration to the end of the study, male subjects who are sexually active and have not been sterilized, and their female partners who are still fertile, the subjects themselves and their partners not using effective contraceptive measures (effective contraceptive measures mean methods that have an unintended pregnancy rate of less than 1% each year, including surgical sterilization, condoms, intrauterine device (birth control ring), abstinence).
- Women of childbearing age who are pregnant, breastfeeding, preparing for pregnancy, and have not used effective contraceptive measures, or postmenopausal women who have had less than 1 year of amenorrhea and serum follicle stimulating hormone (FSH) level ≤ 40 IU/L and have not used effective contraceptive measures.
- During the COVID-19 pandemic period, those who have lived or traveled in areas with a high incidence of COVID-19, have contact history with confirmed or suspected infected people, have a history of fever clinic visits, or those who are positive for the COVID-19 nucleic acid test/positive for the new coronavirus seroantibodies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Active-controlled, Randomized, Three-cycle, Crossover Trial to Evaluate the Pharmacokinetics and Pharmacodynamics of Single-Dose THDB0206 Injection in Healthy Chinese Subjects
This is a single-center, single-dose, open-label, positive-controlled, randomized, three-cycle, crossover 8-hour euglycemic clamp study to evaluate the PK, PD, safety and tolerability of THDB0206 injection after subcutaneous injection in healthy Chinese subjects. This trial will enroll 39 subjects to receive the investigational medicinal products.
- Conditions
- Healthy
- Being tested
- THDB0206 injection, Humalog®, BC222insulin lispro injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THDB0206 injectionDrug
0.2 U/kg, single-dose administration, subcutaneous injection 5 cm laterally from the belly button on the left or right side of the abdominal wall
Humalog®Drug
0.2 U/kg, single-dose administration, subcutaneous injection 5 cm laterally from the belly button on the left or right side of the abdominal wall
BC222insulin lispro injectionDrug
0.2 U/kg, single-dose administration, subcutaneous injection 5 cm laterally from the belly button on the left or right side of the abdominal wall
| Study group | Role | What they receive |
|---|---|---|
| THDB0206 injection | Experimental | Not described Receives: Drug: THDB0206 injection |
| Humalog® | Active comparator | Not described Receives: Drug: Humalog® |
| BC222insulin lispro injection | Active comparator | Not described Receives: Drug: BC222insulin lispro injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCLisp(0-30 min)
Area under the insulin lispro plasma concentration-time curve from 0 to 30 minutes
Measured: From 0 to 30 minutes
Secondary outcomes (17)
Cmax (Lisp)
The maximum plasma concentration of insulin lispro observed
Measured: From 0 to 8 hours
AUCLisp
Area under the insulin lispro plasma concentration-time curve
Measured: From 0 to 8 hours
tmax(Lisp)
Time to reach the maximum insulin lispro plasma concentration
Measured: From 0 to 8 hours
t1/2
Terminal half-life
Measured: From 0 to 8 hours
CL/F
Apparent clearance
Measured: From 0 to 8 hours
Vz/F
Apparent volume of distribution
Measured: From 0 to 8 hours
AUCGIR
Area under the glucose infusion rate-time curve
Measured: From 0 to 8 hours
GIRtot
Total glucose infusion during clamping
Measured: From 0 to 8 hours
GIRmax
Maximum glucose infusion rate
Measured: From 0 to 8 hours
tGIRmax
Time to reach the maximum glucose infusion rate
Measured: From 0 to 8 hours
Number of participants with abnormal clinical laboratory findings (haematology, biochemistry and urinalysis)
Measured: From the first drug administration to the follow-up visit (3 to 10 days after the last drug administration)
Number of participants with abnormal 12-lead ECG parameters (PR, QR, QRS intervals and QTc)
Measured: From the first drug administration to the follow-up visit (3 to 10 days after the last drug administration)
Number of participants with abnormal vital signs (body temperature, supine blood pressure and pulse rate)
Measured: From the first drug administration to the follow-up visit (3 to 10 days after the last drug administration)
Number of participants with abnormal physical examination (general condition, head and five sense organs, neck, chest, abdomen, spine and limbs, nervous system)
Measured: From the first drug administration to the follow-up visit (3 to 10 days after the last drug administration)
Number of participants with hypoglycemia events in each treatment arm
Measured: From the first drug administration to the follow-up visit (3 to 10 days after the last drug administration)
Number of participants with injection site reactions (spontaneous pain, tenderness, itching, redness, edema, induration/infiltration)
Measured: From the first drug administration to the follow-up visit (3 to 10 days after the last drug administration)
Number of participants with AE and SAE
Measured: From the first drug administration to the follow-up visit (3 to 10 days after the last drug administration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start17 Jun 2021
- Primary completion6 Jun 2022
- Study completion6 Jun 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
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tonghua Dongbao Pharmaceutical Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06153329
- Sponsor's protocol ID
- THDB0206L04
- Status last verified
- Nov 2023
- First submitted
- 17 Nov 2023
- Last updated
- 1 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Active-controlled, Randomized, Three-cycle, Crossover Trial to Evaluate the Pharmacokinetics and Pharmacodynamics of Single-Dose THDB0206 Injection in Healthy Chinese Subjects
- ClinicalTrials.gov ID
- NCT06153329
- Acronym / sponsor ID
- THDB0206L04
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Tonghua Dongbao Pharmaceutical Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 17 Jun 2021 (actual)
- Primary completion
- 6 Jun 2022 (actual)
- Study completion
- 6 Jun 2022 (actual)
- First posted
- 1 Dec 2023 (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 single-center, single-dose, open-label, positive-controlled, randomized, three-cycle, crossover 8-hour euglycemic clamp study to evaluate the PK, PD, safety and tolerability of THDB0206 injection after subcutaneous injection in healthy Chinese subjects. This trial will enroll 39 subjects to receive the investigational medicinal products.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| THDB0206 injection | Experimental | Drug: THDB0206 injection |
| Humalog® | Active comparator | Drug: Humalog® |
| BC222insulin lispro injection | Active comparator | Drug: BC222insulin lispro injection |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subjects who provide a signed and dated informed consent form (Appendix 1) before starting any study-related activities (study-related activities are any procedures that will not be involved during the normal management of subjects).
- Healthy local Chinese males or females, who complete medical history, physical examination and laboratory tests according to the judgment of the investigator.
- Aged ≥ 18 years and ≤ 40 years when signing the informed consent form.
- Body mass index (BMI) ≥ 18 kg/m2 and < 25 kg/m2 at screening, male weight ≥ 50 kg, female weight ≥ 45 kg.
- Intravenous fasting blood glucose < 6.1 mmol/L and intravenous blood glucose < 7.8 mmol/L 2 hours after the glucose load in the 75 g oral glucose tolerance test at screening.
Key exclusion criteria (24 listed)
- Known or suspected allergies to investigational medicinal products and related products, or a history of multiple and/or severe allergies to drugs or food.
- Subjects who have previously participated in this study (participation in the study is defined as randomization), or received any drugs in the clinical development stage within 3 months before the screening of this study.
- Any cancer or history of cancer, including basal cell skin cancer or squamous cell skin cancer.
- According to the judgment of the investigator, any clinically relevant cardiovascular, respiratory, gastrointestinal, liver, kidney, metabolism, endocrine, hematology (bleeding diseases), skin, venereal disease, nervous system, mental disease or other major diseases or related medical history.
- During the screening visit, abnormal values of hematology, blood biochemistry, blood coagulation or urinalysis have clinical significance, and the investigator judges and considers potential diseases.
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 |
|---|---|---|
| THDB0206 injection0.2 U/kg, single-dose administration, subcutaneous injection 5 cm laterally from the belly button on the left or right side of the abdominal wall | Drug | THDB0206 injection |
| Humalog®0.2 U/kg, single-dose administration, subcutaneous injection 5 cm laterally from the belly button on the left or right side of the abdominal wall | Drug | Humalog® |
| BC222insulin lispro injection0.2 U/kg, single-dose administration, subcutaneous injection 5 cm laterally from the belly button on the left or right side of the abdominal wall | Drug | BC222insulin lispro injection |
Primary outcome
AUCLisp(0-30 min)
Time frame: From 0 to 30 minutes
Area under the insulin lispro plasma concentration-time curve from 0 to 30 minutes
17 secondary outcomes
Cmax (Lisp)
Time frame: From 0 to 8 hours
AUCLisp
Time frame: From 0 to 8 hours
tmax(Lisp)
Time frame: From 0 to 8 hours
t1/2
Time frame: From 0 to 8 hours
CL/F
Time frame: From 0 to 8 hours
Vz/F
Time frame: From 0 to 8 hours
AUCGIR
Time frame: From 0 to 8 hours
GIRtot
Time frame: From 0 to 8 hours
GIRmax
Time frame: From 0 to 8 hours
tGIRmax
Time frame: From 0 to 8 hours
Number of participants with abnormal clinical laboratory findings (haematology, biochemistry and urinalysis)
Time frame: From the first drug administration to the follow-up visit (3 to 10 days after the last drug administration)
Number of participants with abnormal 12-lead ECG parameters (PR, QR, QRS intervals and QTc)
Time frame: From the first drug administration to the follow-up visit (3 to 10 days after the last drug administration)
Number of participants with abnormal vital signs (body temperature, supine blood pressure and pulse rate)
Time frame: From the first drug administration to the follow-up visit (3 to 10 days after the last drug administration)
Number of participants with abnormal physical examination (general condition, head and five sense organs, neck, chest, abdomen, spine and limbs, nervous system)
Time frame: From the first drug administration to the follow-up visit (3 to 10 days after the last drug administration)
Number of participants with hypoglycemia events in each treatment arm
Time frame: From the first drug administration to the follow-up visit (3 to 10 days after the last drug administration)
Number of participants with injection site reactions (spontaneous pain, tenderness, itching, redness, edema, induration/infiltration)
Time frame: From the first drug administration to the follow-up visit (3 to 10 days after the last drug administration)
Number of participants with AE and SAE
Time frame: From the first drug administration to the follow-up visit (3 to 10 days after the last drug administration)
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 1 Dec 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 THDB0206 injection, Humalog® and BC222insulin lispro injection in people with Healthy, run by Tonghua Dongbao Pharmaceutical Co.,Ltd at 1 site in China.
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 6 inclusion and 24 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 1 Dec 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 China. 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?
AUCLisp(0-30 min) (time frame: From 0 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 1 Dec 2023.