A Comparative Study of TG103 Produced by Two Manufacturing Processes in Chinese Healthy Male Subjects

NCT04839744 | Completed Phase 1

• 1 other identifier: SYSA1803-CSP-005
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to evaluate the comparability of TG103 injection subject to changes in the manufacturing process in Chinese healthy male subjects.

Conditions

Healthy Male Subjects

Outcome Measures

Primary Outcomes (2)

• Peak Plasma Concentration (Cmax)

  Day1-5, 7,9,10, 15, and 28

• Area under the plasma concentration versus time curve (AUC)

  Day1-5, 7,9,10, 15, and 28

Secondary Outcomes (4)

• Change from baseline in Fasting blood glucose(FPG)

  Day1-5, and 7

• Change from baseline in 2-hour postprandial blood glucose(2hPG)

  Day1-5, and 7

• Number of participants with treatment-emergent adverse events

  Up to 28 days

• Concentration of Antidrug antibodies(ADA)

  Day1, 15, and 28

Study Arms (2)

TG103 produced by the modified manufacturing process

EXPERIMENTAL

A single dose of TG103 (15mg) produced by the modified manufacturing process will be administered subcutaneously (SC) in healthy male subjects.

Drug: TG103 produced by the modified manufacturing process

TG103 produced by the original manufacturing process original manufacturing process

ACTIVE COMPARATOR

A single dose of TG103 (15mg) produced by the original manufacturing process will be administered subcutaneously (SC) in healthy male subjects.

Drug: TG103 produced by the original manufacturing process

Interventions

TG103 produced by the modified manufacturing process DRUG

Drug: TG103 (a modified manufacturing process), 15mg, SC

TG103 produced by the modified manufacturing process

TG103 produced by the original manufacturing process DRUG

Drug: TG103 (the original manufacturing process), 15mg, SC

TG103 produced by the original manufacturing process original manufacturing process

Eligibility Criteria

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

You may qualify if:

• \. Male subjects between 18 and 45 years of age, inclusive;
• \. The subject is in good health as determined by medical history, physical examination and clinical laboratory parameters, such as vital signs, 12-lead ECG, imaging examinations (such as thyroid color Doppler ultrasound, abdominal color Doppler ultrasound, chest X-ray);
• \. Weight ≥ 50kg, body mass index (BMI) between 19-26 kg / m2 (inclusive) \[BMI = weight (kg) / height 2 (m2)\];
• \. The subject has a blood glucose between 3.9-6.1 mmol / L (exclusive) and the HbA1c \< 6.5%;
• \. From the date of signing an informed consent to at least 3 months after the administration, the subject must use reliable contraceptive methods to prevent pregnancy;
• \. The subjects fully understand the content of the trial and the possible adverse reactions, have the ability to communicate with the researchers normally, willing and able to comply with all requirements defined in the protocol;
• \. Voluntarily to participate in the study and sign the informed consent form.

You may not qualify if:

• \. Subjects who have a history of certain allergic conditions (such as asthma, urticaria), or have a history of allergy to two or more drugs or food, or may be allergic to the test drug and the related compounds;
• \. Have a history of serious diseases, such as neurological, hepatic, renal, cardiovascular, haematological, pulmonary diseases, or other significant diseases capable of significantly altering the absorption, metabolism, or elimination of the study drug, of constituting a risk when taking the study drug; or of interfering with the interpretation of data;
• \. Have undergone major surgery within 3 months before screening or have severe infection within 4 weeks before screening;
• \. With thyroid dysfunction requiring drug treatment, or not reaching clinical stability after treatment, or with other endocrine diseases that may affect blood glucose metabolism;
• \. Have a history of or current pancreatitis (history of chronic or acute pancreatitis);
• \. Have a history of or current cholecystitis;
• \. With clinically significant abnormal gastric emptying (such as gastric outlet obstruction) and severe chronic gastrointestinal diseases (such as active ulcer within 6 months);
• \. Have a history (or family history) of medullary thyroid cancer (MTC), type 2 multiple endocrine neoplasia syndrome or other hereditary diseases that are thought to induce MTC;
• \. Have a history of malignant tumour, mental illness, depression, anxiety and epilepsy;
• \. Have a history of drug dependence in the past one year or have a positive urine drug screen before administration;
• \. Vaccinated within 28 days before screening or planned to be vaccinated within 1 week after receiving the study drug;
• \. Have a positive test result of hepatitis B surface antigen, hepatitis C antibody, anti-human immunodeficiency virus antibody or anti-Treponema pallidum specific antibody;
• \. Blood loss greater than 400 ml due to blood donation or other reasons within 3 months before screening;
• \. Have used Glucagon-like peptide-1 (GLP-1) analogues, GLP-1 receptor agonists or any other incretin analogues three months before the planned study drug , or other drugs that are thought to affect the trial in the opinion of the researchers;
• \. Within 3 months before administration, subjects used drugs that may cause changes in blood glucose level;

Sponsors & Collaborators

• CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.: lead

Study Sites (1)

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210008, China

Location

Study Officials

• Juan Li

  The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: April 9, 2021
• Study Start: May 18, 2021
• Primary Completion: June 15, 2021
• Study Completion: July 2, 2021
• Last Updated: December 22, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)