HealthyPhase 1NCT06744868
A Single- and Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of THDBH120 Injection in Healthy Subjects
A Phase 1 study testing THDBH120 injection (SAD) and THDBH120 injection (MAD) in people with Healthy, run by Tonghua Dongbao Pharmaceutical Co.,Ltd at 1 site in China.
Trial summary
This study includes single-ascending dose cohorts (SAD cohorts) and multiple-ascending dose cohorts (MAD cohorts). The aim of this trial is to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of THDBH120 injection in healthy patients. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- THDBH120 injection (SAD) and THDBH120 injection (MAD)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 19 Dec 2023to 22 Sep 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Chinese subjects aged 18 to 45 years (inclusive), male or female;
- Body Mass Index (BMI) ≥ 19 kg/m2 and ≤ 28kg/m2, male weight ≥ 50 kg, females weight≥ 45 kg;
- Normal or abnormal but not clinically significant physical examination and vital signs at screening.
Who cannot join
- Have a diagnosis of type 2 diabetes or have had episode of severe hypoglycemia;
- Pulse rate is less than 50 bpm or more than 100 bpm at screening;
- 12-lead electrocardiogram with prolonged QTcF (male >450 ms, female >470 ms) or PR>200ms. Or any other situation in which a 12-lead ECG suggests a risk of ineligibility at screening;
- A history of pancreatitis (including chronic pancreatitis or idiopathic acute pancreatitis), abnormal amylase and lipase with clinical significance or gastrointestinal injury (e.g., chronic gastritis, peptic ulcer, recurrent gastroesophageal reflux disease, cholecystitis, and gallstones) or any gastrointestinal disease that interferes with gastric emptying (e.g., gastric bypass surgery, pyloric stenosis);
- Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2;
- Use of SGLT inhibitors, DPP4 inhibitors, GLP-1 analogs, GLP-1 receptor agonists, and other drugs that investigators recognize may affect the study during the 3 months prior to randomization;
- Have had a significant change in weight during the 6 months prior to screening, such as weight loss > 10%, or recent significant changes in diet or exercise habits.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single- and Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of THDBH120 Injection in Healthy Subjects: A Randomized, Bouble-Blind, Placebo-Controlled Phase I Trial
This study includes single-ascending dose cohorts (SAD cohorts) and multiple-ascending dose cohorts (MAD cohorts). The aim of this trial is to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of THDBH120 injection in healthy patients.
- Conditions
- Healthy
- Being tested
- THDBH120 injection (SAD), Placebo of THDBH120 injection (SAD), THDBH120 injection (MAD), Placebo of THDBH120 injection (MAD)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THDBH120 injection (SAD)Drug
Participants received escalating single doses of THDBH120 by subcutaneous injection.
Placebo of THDBH120 injection (SAD)Drug
Participants received single dose of placebo by subcutaneous injection.
THDBH120 injection (MAD)Drug
Participants received multiple doses of THDBH120 once weekly for four weeks by subcutaneous injection.
Placebo of THDBH120 injection (MAD)Drug
Participants received placebo once weekly for four weeks by subcutaneous injection.
| Study group | Role | What they receive |
|---|---|---|
| THDBH120 injection (SAD) | Experimental | Not described Receives: Drug: THDBH120 injection (SAD) |
| Placebo of THDBH120 injection (SAD) | Placebo comparator | Not described Receives: Drug: Placebo of THDBH120 injection (SAD) |
| THDBH120 injection (MAD) | Experimental | Not described Receives: Drug: THDBH120 injection (MAD) |
| Placebo of THDBH120 injection (MAD) | Placebo comparator | Not described Receives: Drug: Placebo of THDBH120 injection (MAD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with One or More Adverse Event(s) and Serious Adverse Event(s)
Measured: From the first drug administration to the follow-up visit (57 days after the last drug administration)
Secondary outcomes (4)
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of THDBH120.
Measured: Day 1 Pre-dose through Day 42 (SAD), Day 1 Pre-dose through Day 29 (MAD)
Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of THDBH120
Measured: Day 1 Pre-dose through Day 42 (SAD), Day 1 Pre-dose through Day 29 (MAD)
Evaluate the Fasting Blood Glucose (FBG ) of THDBH120
Measured: Day 1 Pre-dose through Day 8 (SAD), Day 1 Pre-dose through Day 29 (MAD)
Number of Participants With Anti-THBHD120 Antibodies
Measured: From the first drug administration to the follow-up visit (57 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 posted20 Dec 2024
- Study start19 Dec 2023
- Primary completion22 Sep 2024
- Study completion22 Sep 2024
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 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
- NCT06744868
- Sponsor's protocol ID
- THDBH120L101
- Status last verified
- Dec 2024
- First submitted
- 17 Dec 2024
- Last updated
- 27 Dec 2024
- 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 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single- and Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of THDBH120 Injection in Healthy Subjects: A Randomized, Bouble-Blind, Placebo-Controlled Phase I Trial
- ClinicalTrials.gov ID
- NCT06744868
- Acronym / sponsor ID
- THDBH120L101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Tonghua Dongbao Pharmaceutical Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 19 Dec 2023 (actual)
- Primary completion
- 22 Sep 2024 (actual)
- Study completion
- 22 Sep 2024 (actual)
- First posted
- 20 Dec 2024 (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 study includes single-ascending dose cohorts (SAD cohorts) and multiple-ascending dose cohorts (MAD cohorts). The aim of this trial is to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of THDBH120 injection in healthy patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| THDBH120 injection (SAD) | Experimental | Drug: THDBH120 injection (SAD) |
| Placebo of THDBH120 injection (SAD) | Placebo comparator | Drug: Placebo of THDBH120 injection (SAD) |
| THDBH120 injection (MAD) | Experimental | Drug: THDBH120 injection (MAD) |
| Placebo of THDBH120 injection (MAD) | Placebo comparator | Drug: Placebo of THDBH120 injection (MAD) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy Chinese subjects aged 18 to 45 years (inclusive), male or female;
- Body Mass Index (BMI) ≥ 19 kg/m2 and ≤ 28kg/m2, male weight ≥ 50 kg, females weight≥ 45 kg;
- Normal or abnormal but not clinically significant physical examination and vital signs at screening.
Key exclusion criteria (7 listed)
- Have a diagnosis of type 2 diabetes or have had episode of severe hypoglycemia;
- Pulse rate is less than 50 bpm or more than 100 bpm at screening;
- 12-lead electrocardiogram with prolonged QTcF (male >450 ms, female >470 ms) or PR>200ms. Or any other situation in which a 12-lead ECG suggests a risk of ineligibility at screening;
- A history of pancreatitis (including chronic pancreatitis or idiopathic acute pancreatitis), abnormal amylase and lipase with clinical significance or gastrointestinal injury (e.g., chronic gastritis, peptic ulcer, recurrent gastroesophageal reflux disease, cholecystitis, and gallstones) or any gastrointestinal disease that interferes with gastric emptying (e.g., gastric bypass surgery, pyloric stenosis);
- Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2;
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 |
|---|---|---|
| THDBH120 injection (SAD)Participants received escalating single doses of THDBH120 by subcutaneous injection. | Drug | THDBH120 injection (SAD) |
| Placebo of THDBH120 injection (SAD)Participants received single dose of placebo by subcutaneous injection. | Drug | Placebo of THDBH120 injection (SAD) |
| THDBH120 injection (MAD)Participants received multiple doses of THDBH120 once weekly for four weeks by subcutaneous injection. | Drug | THDBH120 injection (MAD) |
| Placebo of THDBH120 injection (MAD)Participants received placebo once weekly for four weeks by subcutaneous injection. | Drug | Placebo of THDBH120 injection (MAD) |
Primary outcome
Number of Participants with One or More Adverse Event(s) and Serious Adverse Event(s)
Time frame: From the first drug administration to the follow-up visit (57 days after the last drug administration)
4 secondary outcomes
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of THDBH120.
Time frame: Day 1 Pre-dose through Day 42 (SAD), Day 1 Pre-dose through Day 29 (MAD)
Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of THDBH120
Time frame: Day 1 Pre-dose through Day 42 (SAD), Day 1 Pre-dose through Day 29 (MAD)
Evaluate the Fasting Blood Glucose (FBG ) of THDBH120
Time frame: Day 1 Pre-dose through Day 8 (SAD), Day 1 Pre-dose through Day 29 (MAD)
Number of Participants With Anti-THBHD120 Antibodies
Time frame: From the first drug administration to the follow-up visit (57 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 27 Dec 2024.
- 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 THDBH120 injection (SAD) and THDBH120 injection (MAD) 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 3 inclusion and 7 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 27 Dec 2024. 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. Some participants in this study may receive a placebo. 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?
Number of Participants with One or More Adverse Event(s) and Serious Adverse Event(s) (time frame: From the first drug administration to the follow-up visit (57 days after the last drug 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 27 Dec 2024.