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

NCT06744868 | Completed Phase 1

• 1 other identifier: THDBH120L101
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Number of Participants with One or More Adverse Event(s) and Serious Adverse Event(s)

  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.

  Day 1 Pre-dose through Day 42 (SAD), Day 1 Pre-dose through Day 29 (MAD)

• Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of THDBH120

  Day 1 Pre-dose through Day 42 (SAD), Day 1 Pre-dose through Day 29 (MAD)

• Evaluate the Fasting Blood Glucose (FBG ) of THDBH120

  Day 1 Pre-dose through Day 8 (SAD), Day 1 Pre-dose through Day 29 (MAD)

• Number of Participants With Anti-THBHD120 Antibodies

  From the first drug administration to the follow-up visit (57 days after the last drug administration)

Study Arms (4)

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)

Interventions

THDBH120 injection (SAD) DRUG

Participants received escalating single doses of THDBH120 by subcutaneous injection.

THDBH120 injection (SAD)

Placebo of THDBH120 injection (SAD) DRUG

Participants received single dose of placebo by subcutaneous injection.

Placebo of THDBH120 injection (SAD)

THDBH120 injection (MAD) DRUG

Participants received multiple doses of THDBH120 once weekly for four weeks by subcutaneous injection.

THDBH120 injection (MAD)

Placebo of THDBH120 injection (MAD) DRUG

Participants received placebo once weekly for four weeks by subcutaneous injection.

Placebo of THDBH120 injection (MAD)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Tonghua Dongbao Pharmaceutical Co.,Ltd: lead

Study Sites (1)

Peking University First Hospital

Beijing, China

Location

MeSH Terms

Interventions

Sagittal Abdominal Diameter; mycophenolic adenine dinucleotide

Intervention Hierarchy (Ancestors)

Body Size; Body Weights and Measures; Body Constitution; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Anthropometry; Investigative Techniques; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 20, 2024
• Study Start: December 19, 2023
• Primary Completion: September 22, 2024
• Study Completion: September 22, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)