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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: THDBH120 injection (SAD); Drug: Placebo of THDBH120 injection (SAD); Drug: THDBH120 injection (MAD); Drug: Placebo of THDBH120 injection (MAD)

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Peking University First Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: THDBH120 injection (SAD)	Drug: THDBH120 injection (SAD); Participants received escalating single doses of THDBH120 by subcutaneous injection.
Placebo Comparator: Placebo of THDBH120 injection (SAD)	Drug: Placebo of THDBH120 injection (SAD); Participants received single dose of placebo by subcutaneous injection.
Experimental: THDBH120 injection (MAD)	Drug: THDBH120 injection (MAD); Participants received multiple doses of THDBH120 once weekly for four weeks by subcutaneous injection.
Placebo Comparator: Placebo of THDBH120 injection (MAD)	Drug: Placebo of THDBH120 injection (MAD); Participants received placebo once weekly for four weeks by subcutaneous injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: Tonghua Dongbao Pharmaceutical Co.,Ltd

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2023
• Primary Completion (Actual): September 22, 2024
• Study Completion (Actual): September 22, 2024

Study Registration Dates

• First Submitted: December 17, 2024
• First Submitted That Met QC Criteria: December 17, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 20, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: THDBH120L101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No