Clinical trial NCT06744868: A Single- and Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of THDBH120 Injection in Healthy Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Tonghua Dongbao Pharmaceutical Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2024-12-20
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Number of Participants with One or More Adverse Event(s) and Serious Adverse Event(s)
timeFrame: From the first drug administration to the follow-up visit (57 days after the last drug administration)
Secondary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of THDBH120.
timeFrame: Day 1 Pre-dose through Day 42 (SAD), Day 1 Pre-dose through Day 29 (MAD)
measure: Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of THDBH120
timeFrame: Day 1 Pre-dose through Day 42 (SAD), Day 1 Pre-dose through Day 29 (MAD)
measure: Evaluate the Fasting Blood Glucose (FBG ) of THDBH120
timeFrame: Day 1 Pre-dose through Day 8 (SAD), Day 1 Pre-dose through Day 29 (MAD)
measure: Number of Participants With Anti-THBHD120 Antibodies
timeFrame: From the first drug administration to the follow-up visit (57 days after the last drug administration)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
Study officials:
References: