A Trial to Evaluate the Pharmacokinetics and Pharmacodynamics of THDB0206 Injection in Healthy Chinese Subjects

NCT06153329 | Completed Phase 1

• 1 other identifier: THDB0206L04
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, single-dose, open-label, positive-controlled, randomized, three-cycle, crossover 8-hour euglycemic clamp study to evaluate the PK, PD, safety and tolerability of THDB0206 injection after subcutaneous injection in healthy Chinese subjects. This trial will enroll 39 subjects to receive the investigational medicinal products.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• AUCLisp(0-30 min)

  Area under the insulin lispro plasma concentration-time curve from 0 to 30 minutes

  From 0 to 30 minutes

Secondary Outcomes (17)

• Cmax (Lisp)

  From 0 to 8 hours

• AUCLisp

  From 0 to 8 hours

• tmax(Lisp)

  From 0 to 8 hours

• t1/2

  From 0 to 8 hours

• CL/F

  From 0 to 8 hours

Study Arms (3)

THDB0206 injection

EXPERIMENTAL

Drug: THDB0206 injection

Humalog®

ACTIVE COMPARATOR

Drug: Humalog®

BC222insulin lispro injection

ACTIVE COMPARATOR

Drug: BC222insulin lispro injection

Interventions

THDB0206 injection DRUG

0.2 U/kg, single-dose administration, subcutaneous injection 5 cm laterally from the belly button on the left or right side of the abdominal wall

THDB0206 injection

Humalog® DRUG

0.2 U/kg, single-dose administration, subcutaneous injection 5 cm laterally from the belly button on the left or right side of the abdominal wall

Humalog®

BC222insulin lispro injection DRUG

0.2 U/kg, single-dose administration, subcutaneous injection 5 cm laterally from the belly button on the left or right side of the abdominal wall

BC222insulin lispro injection

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects who provide a signed and dated informed consent form (Appendix 1) before starting any study-related activities (study-related activities are any procedures that will not be involved during the normal management of subjects).
• Healthy local Chinese males or females, who complete medical history, physical examination and laboratory tests according to the judgment of the investigator.
• Aged ≥ 18 years and ≤ 40 years when signing the informed consent form.
• Body mass index (BMI) ≥ 18 kg/m2 and \< 25 kg/m2 at screening, male weight ≥ 50 kg, female weight ≥ 45 kg.
• Intravenous fasting blood glucose \< 6.1 mmol/L and intravenous blood glucose \< 7.8 mmol/L 2 hours after the glucose load in the 75 g oral glucose tolerance test at screening.
• According to local laboratory analysis, glycated hemoglobin HbA1c≤6.1% st screening.

You may not qualify if:

• Subjects who meet any of the following criteria will be excluded from the study:
• Known or suspected allergies to investigational medicinal products and related products, or a history of multiple and/or severe allergies to drugs or food.
• Subjects who have previously participated in this study (participation in the study is defined as randomization), or received any drugs in the clinical development stage within 3 months before the screening of this study.
• Any cancer or history of cancer, including basal cell skin cancer or squamous cell skin cancer.
• According to the judgment of the investigator, any clinically relevant cardiovascular, respiratory, gastrointestinal, liver, kidney, metabolism, endocrine, hematology (bleeding diseases), skin, venereal disease, nervous system, mental disease or other major diseases or related medical history.
• During the screening visit, abnormal values of hematology, blood biochemistry, blood coagulation or urinalysis have clinical significance, and the investigator judges and considers potential diseases.
• According to the judgment of the investigator, the results of the insulin release test has clinically significant abnormalities at screening.
• Heart problems, defined as the presence of decompensated heart failure (New York Heart Association Class III and IV) at any time and/or angina pectoris within 12 months prior to screening and/or acute myocardial infarction at any time.
• According to the judgment of the investigator, the blood pressure has clinically significant abnormalities at screening.
• The heart rate detected by 12-lead ECG at rest exceeds the range of 50-100 beats per minute (including 50 and 100 beats).
• According to the judgment of the investigator, the standard 12-lead ECG has clinically significant abnormalities at screening.
• Increased risk of thromboembolism, such as known coagulopathy, (family) history of thrombosis, related arrhythmias (e.g., paroxysmal atrial fibrillation), etc.
• Mental disorders or language barriers which prevent full understanding or cooperation.
• According to the investigator's judgment, there is a history of deep vein thrombosis in the lower extremities or a first-degree relative (parents, siblings or children) frequently develops deep vein thrombosis in the lower extremities.
• Any disease or condition that the investigator believes will pose an unacceptable risk to the safety of the subjects.

Sponsors & Collaborators

• Tonghua Dongbao Pharmaceutical Co.,Ltd: lead

Study Sites (1)

West China Hospital of Sichuan University

Sichuan, China

Location

MeSH Terms

Interventions

Insulin Lispro

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2023
• First Posted: December 1, 2023
• Study Start: June 17, 2021
• Primary Completion: June 6, 2022
• Study Completion: June 6, 2022
• Last Updated: December 1, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)