Healthy ParticipantsPhase 1NCT07257627
Comparative PK/PD of Single-Dose THDB0206 at Different Injection Sites
A Phase 1 study testing THDB0206 injection-Upper arm, THDB0206 Injection-Abdomen and THDB0206 Injection-Thigh in people with Healthy Participants, run by Tonghua Dongbao Pharmaceutical Co.,Ltd at 1 site in China.
Trial summary
This open-label, randomized, three-period crossover, 8-hour hyperinsulinemic-euglycemic clamp study will compare the pharmacokinetic and pharmacodynamic profiles of THDB0206 after single subcutaneous administration at different injection sites in healthy Chinese adults. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- THDB0206 injection-Upper arm, THDB0206 Injection-Abdomen and THDB0206 Injection-Thigh
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteChina
- Study dates
- 17 Apr 2024to 2 Dec 2024
- 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
- Aged ≥18 and ≤40 years at screening.
- Body mass index (BMI) ≥18 kg/m² and <25 kg/m² at screening; body weight ≥50 kg for males and ≥45 kg for females at screening.
- At screening, 75 g oral glucose tolerance test (OGTT): fasting venous plasma glucose <6.1 mmol/L and 2-hour post-load venous plasma glucose <7.8 mmol/L.
- Glycated hemoglobin (HbA1c) ≤6.1% at screening.
Who cannot join
- Known or suspected hypersensitivity to the investigational product or related products, or a history of severe allergies to drugs or foods.
- Insulin release test at screening considered abnormal with clinical significance in the investigator's judgment.
- Increased risk of thromboembolism, such as known coagulation disorders, (family) history of thrombosis, or relevant arrhythmias (e.g., paroxysmal atrial fibrillation).
- In the investigator's judgment, a history of alcohol dependence or drug/chemical substance abuse; or positive results on drug screening/breath alcohol testing at screening; or alcohol consumption exceeding 21 units per week (male subjects) or 14 units per week (female subjects).
- Subjects who smoked on average more than 5 cigarettes per day within 1 year prior to screening and are unwilling to abstain from smoking during the study.
- Donation of blood or plasma within the past month, or donation of more than 300 mL of blood within 3 months prior to screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Randomized, Three-Period Crossover Study Comparing the Pharmacokinetics and Pharmacodynamics of Single-Dose THDB0206 Injection at Different Injection Sites in Healthy Chinese Adults
This open-label, randomized, three-period crossover, 8-hour hyperinsulinemic-euglycemic clamp study will compare the pharmacokinetic and pharmacodynamic profiles of THDB0206 after single subcutaneous administration at different injection sites in healthy Chinese adults.
- Conditions
- Healthy Participants
- Being tested
- THDB0206 injection-Upper arm, THDB0206 Injection-Abdomen, THDB0206 Injection-Thigh
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THDB0206 injection-Upper armDrug
Subjects received a single subcutaneous injection of THDB0206 at a dose of 0.2 U/kg in the upper arm.
THDB0206 Injection-AbdomenDrug
Subjects received a single subcutaneous injection of THDB0206 at a dose of 0.2 U/kg in the abdomen.
THDB0206 Injection-ThighDrug
Subjects received a single subcutaneous injection of THDB0206 at a dose of 0.2 U/kg in the thigh.
| Study group | Role | What they receive |
|---|---|---|
| THDB0206 injection-Upper Arm | Experimental | Not described Receives: Drug: THDB0206 injection-Upper arm |
| THDB0206 injection-Abdomen | Experimental | Not described Receives: Drug: THDB0206 Injection-Abdomen |
| THDB0206 injection-Thigh | Experimental | Not described Receives: Drug: THDB0206 Injection-Thigh |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCLisp(0-inf)
Area under the insulin lispro plasma concentration-time curve from zero to infinity
Measured: From 0 to 8 hours
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
CL/F
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, and others)
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 posted2 Dec 2025
- Study start17 Apr 2024
- Primary completion2 Dec 2024
- Study completion2 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- 27 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
- NCT07257627
- Sponsor's protocol ID
- THDB0206L03
- Status last verified
- Oct 2025
- First submitted
- 14 Nov 2025
- Last updated
- 2 Dec 2025
- 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 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, Three-Period Crossover Study Comparing the Pharmacokinetics and Pharmacodynamics of Single-Dose THDB0206 Injection at Different Injection Sites in Healthy Chinese Adults
- ClinicalTrials.gov ID
- NCT07257627
- Acronym / sponsor ID
- THDB0206L03
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Tonghua Dongbao Pharmaceutical Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 17 Apr 2024 (actual)
- Primary completion
- 2 Dec 2024 (actual)
- Study completion
- 2 Dec 2024 (actual)
- First posted
- 2 Dec 2025 (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 open-label, randomized, three-period crossover, 8-hour hyperinsulinemic-euglycemic clamp study will compare the pharmacokinetic and pharmacodynamic profiles of THDB0206 after single subcutaneous administration at different injection sites in healthy Chinese adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| THDB0206 injection-Upper Arm | Experimental | Drug: THDB0206 injection-Upper arm |
| THDB0206 injection-Abdomen | Experimental | Drug: THDB0206 Injection-Abdomen |
| THDB0206 injection-Thigh | Experimental | Drug: THDB0206 Injection-Thigh |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Aged ≥18 and ≤40 years at screening.
- Body mass index (BMI) ≥18 kg/m² and <25 kg/m² at screening; body weight ≥50 kg for males and ≥45 kg for females at screening.
- At screening, 75 g oral glucose tolerance test (OGTT): fasting venous plasma glucose <6.1 mmol/L and 2-hour post-load venous plasma glucose <7.8 mmol/L.
- Glycated hemoglobin (HbA1c) ≤6.1% at screening.
Key exclusion criteria (6 listed)
- Known or suspected hypersensitivity to the investigational product or related products, or a history of severe allergies to drugs or foods.
- Insulin release test at screening considered abnormal with clinical significance in the investigator's judgment.
- Increased risk of thromboembolism, such as known coagulation disorders, (family) history of thrombosis, or relevant arrhythmias (e.g., paroxysmal atrial fibrillation).
- In the investigator's judgment, a history of alcohol dependence or drug/chemical substance abuse; or positive results on drug screening/breath alcohol testing at screening; or alcohol consumption exceeding 21 units per week (male subjects) or 14 units per week (female subjects).
- Subjects who smoked on average more than 5 cigarettes per day within 1 year prior to screening and are unwilling to abstain from smoking during the study.
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 injection-Upper armSubjects received a single subcutaneous injection of THDB0206 at a dose of 0.2 U/kg in the upper arm. | Drug | THDB0206 injection-Upper Arm |
| THDB0206 Injection-AbdomenSubjects received a single subcutaneous injection of THDB0206 at a dose of 0.2 U/kg in the abdomen. | Drug | THDB0206 injection-Abdomen |
| THDB0206 Injection-ThighSubjects received a single subcutaneous injection of THDB0206 at a dose of 0.2 U/kg in the thigh. | Drug | THDB0206 injection-Thigh |
Primary outcome
AUCLisp(0-inf)
Time frame: From 0 to 8 hours
Area under the insulin lispro plasma concentration-time curve from zero to infinity
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, and others)
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 2 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Healthy Participants
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
Recruiting
Effect of a Fermented Dairy Protein With Prebiotic Fiber on GI Complaints
Digestive Health, Quality of Life
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
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-Upper arm, THDB0206 Injection-Abdomen and THDB0206 Injection-Thigh in people with Healthy Participants, 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 4 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 2 Dec 2025. 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-inf) (time frame: From 0 to 8 hours). 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 2 Dec 2025.