A Single- and Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of THDBH120 Injection in Healthy Subjects

Tonghua Dongbao Pharma

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: THDBH120 injection (MAD); Drug: THDBH120 injection (SAD); Drug: Placebo of THDBH120 injection (SAD); Drug: Placebo of THDBH120 injection (MAD)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06744868

THDBH120L101

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 4 patient groups, including a placebo group

THDBH120 injection (SAD)

Experimental group

Treatment:

Drug: THDBH120 injection (SAD)

Placebo of THDBH120 injection (SAD)

Placebo Comparator group

Treatment:

Drug: Placebo of THDBH120 injection (SAD)

THDBH120 injection (MAD)

Experimental group

Treatment:

Drug: THDBH120 injection (MAD)

Placebo of THDBH120 injection (MAD)

Placebo Comparator group

Treatment:

Drug: Placebo of THDBH120 injection (MAD)