Healthy Male SubjectsPhase 1NCT04839744

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

A Phase 1 study testing TG103 produced by the modified manufacturing process and TG103 produced by the original manufacturing process in people with Healthy Male Subjects, run by CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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

Who is it for?: Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy Male Subjects
What is being tested?: TG103 produced by the modified manufacturing process and TG103 produced by the original manufacturing process
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteChina
Study dates: 18 May 2021to 2 Jul 2021
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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;

Show all 23Show fewer

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.).

Trial locations and contacts

1 site in 1 country.

China1 site

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008

Other trials in China

About this study

Official title: 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

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

Read the detailed description

This is a randomized, open-label, parallel-group, comparative study to evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) profiles, safety, and immunogenicity of TG103 injection produced by two different manufacturing processes in Chinese healthy male subjects. Approximately 24 eligible subjects will be randomized in a 1:1 ratio to receive a single dose of TG103 produced by the modified manufacturing process or TG103 produced by the original manufacturing process via subcutaneous (SC) injection.

Conditions: Healthy Male Subjects
Being tested: TG103 produced by the modified manufacturing process, TG103 produced by the original manufacturing process

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TG103 produced by the modified manufacturing processDrug
Drug: TG103 (a modified manufacturing process), 15mg, SC
TG103 produced by the original manufacturing processDrug
Drug: TG103 (the original manufacturing process), 15mg, SC

Study groups in NCT04839744
Study group	Role	What they receive
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. Receives: 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. Receives: Drug: TG103 produced by the original manufacturing process

What is being measured

The primary outcome is the main question the study is designed to answer.

Peak Plasma Concentration (Cmax)
Measured: Day1-5, 7,9,10, 15, and 28
Area under the plasma concentration versus time curve (AUC)
Measured: Day1-5, 7,9,10, 15, and 28

Secondary outcomes (4)

Change from baseline in Fasting blood glucose(FPG)
Pharmacodynamic (PD) parameters after administration of of TG103
Measured: Day1-5, and 7
Change from baseline in 2-hour postprandial blood glucose(2hPG)
Pharmacodynamic (PD) parameters after administration of of TG103
Measured: Day1-5, and 7
Number of participants with treatment-emergent adverse events
Pharmacodynamic (PD) parameters after administration of of TG103
Measured: Up to 28 days
Concentration of Antidrug antibodies(ADA)
ADA after administration of of TG103
Measured: Day1, 15, and 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 May 20212 Jul 2021

First posted9 Apr 2021
Study start18 May 2021
Primary completion15 Jun 2021
Study completion2 Jul 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy Male SubjectsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04839744
Sponsor's protocol ID: SYSA1803-CSP-005
Status last verified: Dec 2021
First submitted: 25 Mar 2021
Last updated: 22 Dec 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
A Randomized, Double-Blind, Positive-Controlled, Parallel Pharmacokinetic Phase I Clinical Study of Cetuximab Injection Versus Erbitux in Healthy Male Subjects
Cetuximab, Bioequivalence
RecruitingPhase 1
Absorption, Distribution, Metabolism, and Excretion of 14C-VX-407 After a Single Oral Dose
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
RecruitingObservational study
Urinary Vitamin C Loss in Diabetic Subjects
Diabetes
Not yet recruitingPhase 1
Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX29 Compared With HLX11
Health Adult Subjects
Not yet recruitingPhase 1
Mass Balance Study of [14C]DA-302168S in Healthy Chinese Adult Male Participants
Healthy Adult Subjects

All Healthy Male Subjects trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT04839744
Acronym / sponsor ID: SYSA1803-CSP-005
Conditions: Healthy Male Subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 18 May 2021 (actual)
Primary completion: 15 Jun 2021 (actual)
Study completion: 2 Jul 2021 (actual)
First posted: 9 Apr 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
TG103 produced by the modified manufacturing process	Experimental	Drug: TG103 produced by the modified manufacturing processA single dose of TG103 (15mg) produced by the modified manufacturing process will be administered subcutaneously (SC) in healthy male subjects.
TG103 produced by the original manufacturing process original manufacturing process	Active comparator	Drug: TG103 produced by the original manufacturing processA single dose of TG103 (15mg) produced by the original manufacturing process will be administered subcutaneously (SC) in healthy male subjects.

Who may qualify

Ages: 18 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

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;

Key exclusion criteria (23 listed)

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);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TG103 produced by the modified manufacturing processDrug: TG103 (a modified manufacturing process), 15mg, SC	Drug	TG103 produced by the modified manufacturing process
TG103 produced by the original manufacturing processDrug: TG103 (the original manufacturing process), 15mg, SC	Drug	TG103 produced by the original manufacturing process original manufacturing process

Primary outcome

Peak Plasma Concentration (Cmax)
Time frame: Day1-5, 7,9,10, 15, and 28
Area under the plasma concentration versus time curve (AUC)
Time frame: Day1-5, 7,9,10, 15, and 28

4 secondary outcomes

Change from baseline in Fasting blood glucose(FPG)
Time frame: Day1-5, and 7
Change from baseline in 2-hour postprandial blood glucose(2hPG)
Time frame: Day1-5, and 7
Number of participants with treatment-emergent adverse events
Time frame: Up to 28 days
Concentration of Antidrug antibodies(ADA)
Time frame: Day1, 15, and 28

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2021.
Individual participant dataSharing planned: No

Related trials for Healthy Male Subjects

RecruitingPhase 1
A Randomized, Double-Blind, Positive-Controlled, Parallel Pharmacokinetic Phase I Clinical Study of Cetuximab Injection Versus Erbitux in Healthy Male Subjects
Cetuximab, Bioequivalence
RecruitingPhase 1
Absorption, Distribution, Metabolism, and Excretion of 14C-VX-407 After a Single Oral Dose
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
RecruitingObservational study
Urinary Vitamin C Loss in Diabetic Subjects
Diabetes
Not yet recruitingPhase 1
Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX29 Compared With HLX11
Health Adult Subjects
Not yet recruitingPhase 1
Mass Balance Study of [14C]DA-302168S in Healthy Chinese Adult Male Participants
Healthy Adult Subjects

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Juan Li principal investigator

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peak Plasma Concentration (Cmax) (time frame: Day1-5, 7,9,10, 15, and 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04839744.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2021.