Multiple Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of THDBH120 in Chinese Patients With T2DM

NCT07020949 | Completed Phase 1

• 1 other identifier: THDBH120L102
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this trial is to investigate the safety, tolerability, pharmacokinetics, and efficacy of THDBH120 injection in participants with T2DM. This study includes three multiple-ascending dose cohorts.

Conditions

Diabetes Mellitus Type 2

Outcome Measures

Primary Outcomes (1)

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

  78 days

Secondary Outcomes (4)

• Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of THDBH120.

  Day 1 Pre-dose through Day 43

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

  Day 1 Pre-dose through Day 43

• Change From Baseline in HbA1C

  43 days

• Number of Participants With Anti-THBHD120 Antibodies

  78 days

Study Arms (2)

THDBH120 injection

EXPERIMENTAL

Drug: THDBH120 injection

Placebo of THDBH120 injection

PLACEBO COMPARATOR

Drug: Placebo of THDBH120 injection

Interventions

THDBH120 injection DRUG

Participants received THDBH120 by subcutaneous injection.

THDBH120 injection

Placebo of THDBH120 injection DRUG

Participants received placebo by subcutaneous injection.

Placebo of THDBH120 injection

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients 18 to 75 years of age, inclusive;
• Have T2DM for at least 6 months before screening based on the disease diagnostic criteria (World Health Organization \[WHO\] Classification for Diabetes);
• Treated with diet and exercise alone, or a stable dose of metformin (≥1000 mg/day and not more than the locally approved dose) for at least 2 months prior to screening;
• Have a BMI between 23 and 35 kg/m²(inclusive) at screening;
• HbA1c levels: 7.0% to 10.0% (inclusive) for subjects treated by diet or exercise alone; 7.0% to 9.0% (inclusive) for subjects receiving stable-dose metformin.

You may not qualify if:

• Have been diagnosed with proliferative diabetic retinopathy, diabetic maculopathy, or non-proliferative diabetic retinopathy requiring treatment during the study;
• Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia type 2;
• Have diagnosed hyperthyroidism or hypothyroidism;
• Have grade 2 hypoglycemia events or grade 3 hypoglycemia events within 6 months prior to screening;
• Have a history of ketoacidosis, lactic acidosis, or hyperosmolar state leading to hospitalization within 6 months prior to screening;
• Presence of uncontrolled hypertension at screening: systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg;
• Prolonged QTcF interval on 12-lead ECG at screening (QTcF≥450 ms for males, \>470 ms for females), PR interval \>200 ms, or the presence of long QT syndrome, second- or third-degree atrioventricular block, left or right bundle branch block, Wolff-Parkinson-White syndrome, or any other clinically significant arrhythmias (except sinus arrhythmia);
• Weight change ≥ 5% within 3 months prior to screening;
• Have been treated with insulin, excluding insulin therapy for gestational diabetes mellitus, or acute/temporary insulin therapy (≤ 14 days) for conditions such as acute illness, hospitalization, or elective surgery.

Sponsors & Collaborators

• Tonghua Dongbao Pharmaceutical Co.,Ltd: lead

Study Sites (1)

Peking University First Hospital

Beijing, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

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: June 5, 2025
• First Posted: June 13, 2025
• Study Start: June 13, 2024
• Primary Completion: November 27, 2024
• Study Completion: November 27, 2024
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)