GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

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

A Randomized, Open-label, Parallel-Group, Comparative Study in Chinese Healthy Male Subjects to Evaluate the Safety and Pharmacokinetic Profile of TG103 Injection Produced by Two Different Manufacturing Processes

Lead sponsor

CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

Asset

TG103

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Healthy volunteers

Key I/E criteria

•BMI 19-26•HbA1c ≤6.5%•Male

Primary endpoints

•Peak Plasma Concentration (Cmax)•AUC

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04839744

Org study IDSYSA1803-CSP-005

Timeline

Milestones

Study first posted2021-04-09actual

Study start2021-05-18actual

Primary completion2021-06-15actual

Study completion2021-07-02actual

Last update posted2021-12-22actual

Assets

Investigational agents

TG103

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years

Maximum age45 Years

SexMale

Healthy volunteersAccepted

Inclusion criteria

•1. Male subjects between 18 and 45 years of age, inclusive;

•2. 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);

•3. Weight ≥ 50kg, body mass index (BMI) between 19-26 kg / m2 (inclusive) [BMI = weight (kg) / height 2 (m2)];

•4. The subject has a blood glucose between 3.9-6.1 mmol / L (exclusive) and the HbA1c < 6.5%;

•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;

•6. 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;

•7. Voluntarily to participate in the study and sign the informed consent form.

Exclusion criteria

•1. 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;

•2. 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;

•3. Have undergone major surgery within 3 months before screening or have severe infection within 4 weeks before screening;

•4. With thyroid dysfunction requiring drug treatment, or not reaching clinical stability after treatment, or with other endocrine diseases that may affect blood glucose metabolism;

•5. Have a history of or current pancreatitis (history of chronic or acute pancreatitis);

•6. Have a history of or current cholecystitis;

•7. With clinically significant abnormal gastric emptying (such as gastric outlet obstruction) and severe chronic gastrointestinal diseases (such as active ulcer within 6 months);

•8. 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;

•9. Have a history of malignant tumour, mental illness, depression, anxiety and epilepsy;

•10. Have a history of drug dependence in the past one year or have a positive urine drug screen before administration;

•11. Vaccinated within 28 days before screening or planned to be vaccinated within 1 week after receiving the study drug;

•12. Have a positive test result of hepatitis B surface antigen, hepatitis C antibody, anti-human immunodeficiency virus antibody or anti-Treponema pallidum specific antibody;

•13. Blood loss greater than 400 ml due to blood donation or other reasons within 3 months before screening;

•14. 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;

•15. Within 3 months before administration, subjects used drugs that may cause changes in blood glucose level;

•16. Have used any prescription drug, Chinese herbal medicine or over-the-counter drug within 15 days before screening that are capable of affecting the PK, PD and safety outcomes;

•17. Average alcohol intake is more than 21 units of alcohol (male) per week (1 unit ≈ 360mL beer, or 45mL spirits with 40% alcohol content, or 150mL wine) within the 3 months prior to screening, or a positive ethanol breath test at screening;

•18. Regularly consumption of caffeine is more than 600 mg per day within the 3 months prior to screening (one cup of coffee contains about 100 mg of caffeine, one cup of tea contains about 30 mg of caffeine, and one can of coke contains about 20 mg of caffeine), or those who used caffeinated products within 48 hours before administration;

•19. Smoking more than 5 cigarettes per day within 3 months prior to screening;

•20. According to the judgment of the researcher, the subjects have special dietary requirements;

•21. With dermatitis or abnormal skin conditions at or around the site of administration;

•22. Have participated in another clinical trial involving an investigational product within 3 months prior to the planned administration of the study drug; or the last dose of the previous investigational product has been given in less than 3 months before the screening; or those who would try to participate in other clinical trials during the study period;

•23. Not suitable for this study in the researcher's opinion, such as subjects with poor compliance (long-term business trip, planned relocation, etc.).

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Glycemic / diabetes

2 endpoints

Secondary/protocol endpoint

Change from baseline in Fasting blood glucose(FPG)

Time frame:Day1-5, and 7

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Day1-5, and 7

change from baseline, improvement

Safety / tolerability / PK

4 endpoints

Primary/protocol endpoint

Peak Plasma Concentration (Cmax)

Time frame:Day1-5, 7,9,10, 15, and 28

concentration, descriptive

Primary/protocol endpoint

Area under the plasma concentration versus time curve (AUC)

Time frame:Day1-5, 7,9,10, 15, and 28

concentration, descriptive

Secondary/protocol endpoint

Number of participants with treatment-emergent adverse events

Time frame:Up to 28 days

event count, event

Secondary/protocol endpoint

Concentration of Antidrug antibodies(ADA)

Time frame:Day1, 15, and 28

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.