Healthy Adult Males in ChinaPhase 1NCT07300436
A Study of TJ101 Injection Before and After CMC Change Following Subcutaneous Injection in Healthy Adult Male Subjects in China
A Phase 1 study testing TJ101 injection Test Product and TJ101 injection Reference Product in people with Healthy Adult Males in China, run by TJ Biopharma Co., Ltd. at 1 site in China.
Trial summary
This is Single-center, randomized, open-label, single-dose, two-period crossover study design. The goal is to preliminary evaluate the PK comparability of TJ101 injection before and after CMC change following a single subcutaneous injection of 1.2 mg/kg in healthy male subjects in China, and to assess whether the two… 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 Adult Males in China
- What is being tested?
- TJ101 injection Test Product and TJ101 injection Reference Product
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 4 Jan 2026to 16 Mar 2026
- 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
- Male subjects aged ≥ 18 and ≤ 45 years;
- Body mass index (BMI): 19-28 kg/m2 (inclusive), weight 50-90 kg (inclusive), with BMI calculated as: BMI = weight (kg) / height2 (m2);
- Results of physical examination, vital signs, laboratory tests, 12-lead ECG, chest X-ray (posteroanterior view), and abdominal B-scan ultrasound are normal or clinically insignificant if abnormal;
- Fully understand the purpose and requirements of this study, voluntarily participate in the clinical study and sign the written informed consent form (ICF), and are able to complete the entire study process as required.
Who cannot join
- (Screening/Admission interview) Known history of allergy to the investigational product, any of its components, or related products; or a history of allergic diseases such as asthma; or allergic diathesis (e.g., known allergy to two or more substances);
- (Screening/Admission interview) A definite history of diseases of the central nervous, cardiovascular, digestive, respiratory, urinary, or hematological systems, or metabolic disorders, or potential underlying diseases that are judged by the investigator to be clinically significant; or other diseases that the investigator considers unsuitable for participation in a clinical study (e.g., history of mental illness);
- (Screening/Admission interview) History of severe infection, severe trauma, or major surgery within 6 months prior to screening;
- (Screening/Admission interview) History of blood donation, blood loss ≥ 400 mL, or blood transfusion (at least one of the above) within 3 months prior to screening; or plan to donate blood within 3 months after the end of the study;
- Positive test for any of the following infectious diseases: human immunodeficiency virus antibody, hepatitis B surface antigen, hepatitis C virus antibody, Treponema pallidum specific antibody, and syphilis specific antibody;
- (Screening/Admission interview + Networked screening) Participation in any clinical trial of a drug, vaccine, or medical device within 3 months before the first dose (except for those who only signed the ICF but did not receive any drug, vaccine, or device intervention), or participated more than 3 months ago but are still in the follow-up period of a clinical trial or within 5 half-lives of the investigational drug (whichever is longer) before screening;
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- (Screening/Admission interview) Use of any prescription drugs within 4 weeks before the first dose [including but not limited to any drugs that alter hepatic enzyme activity (e.g., glucocorticoids, sex hormones, anticonvulsants, cyclosporine, etc.)], or use of any over-the-counter drugs (including but not limited to Chinese herbal medicines, compound Chinese herbal preparations, health supplements, etc.) or vitamin supplements within 2 weeks before the first dose;
- (Screening/Admission interview) Prior use of growth hormone drugs;
- Positive for anti-TJ101 anti-drug antibody sample at screening;
- (Screening/Admission interview) History of drug abuse;
- (Screening/Admission interview) Smoke an average of ≥5 cigarettes per day within 3 months prior to screening, or are unable to stop using any tobacco products during the entire study period;
- (Screening/Admission interview) Alcoholic within 3 months prior to screening, defined as weekly alcohol use of more than 14 units (1 unit equals 17.5 mL or 14 g of pure alcohol; alcohol content of different types of alcoholic beverages is indicated by volume ratio, 1 unit of alcohol is approximately equal to 35 mL of 50-proof liquor or 350 mL of 5% beer), or are unwilling to stop alcohol use or consumption of any alcohol-containing products during the study period;
- (Admission period) Positive alcohol breath test or positive urine multi-drug panel test;
- (Screening interview) Difficulty with venipuncture and/or intolerance to intravenous paracentesis/indwelling needle, or have a phobia of needles or blood;
- (Screening/Admission interview) Have plans for procreation or sperm donation from the first dose of the investigational product until 3 months after the last dose, and are unwilling to take reliable contraceptive measures;
- (Screening physical examination) Any condition on the abdomen, such as scars or tattoos, that the investigator judges would interfere with the injection or observation of local reactions at the injection site;
- Other conditions that the investigator considers unsuitable for inclusion in this clinical study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Single-dose, Crossover Bioequivalence Study of TJ101 Injection Before and After CMC Change Following Subcutaneous Injection in Healthy Adult Male Subjects in China
This is Single-center, randomized, open-label, single-dose, two-period crossover study design.
The goal is to preliminary evaluate the PK comparability of TJ101 injection before and after CMC change following a single subcutaneous injection of 1.2 mg/kg in healthy male subjects in China, and to assess whether the two formulations are bio equivalent.
- Conditions
- Healthy Adult Males in China
- Being tested
- TJ101 injection Test Product, TJ101 injection Reference Product
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TJ101 injection Test ProductDrug
1.2 mg/kg, administered by subcutaneous injection in the abdomen,Once per cycle
TJ101 injection Reference ProductDrug
1.2 mg/kg, administered by subcutaneous injection in the abdomen,Once per period
| Study group | Role | What they receive |
|---|---|---|
| Group A（T-R） | Experimental | Not described Receives: Drug: TJ101 injection Test Product; Drug: TJ101 injection Reference Product |
| Group B（R-T） | Experimental | Not described Receives: Drug: TJ101 injection Test Product; Drug: TJ101 injection Reference Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary PK endpoint: Cmax
Maximum Concentration
Measured: 10 days after dosing
Primary PK endpoint: AUC0-inf
Area Under the Concentration-Time Curve from Time Zero to Infinity
Measured: 10 days after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start4 Jan 2026
- Primary completion16 Mar 2026
- Study completion16 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult Males in ChinaStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- TJ Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07300436
- Sponsor's protocol ID
- TJ101001BE102
- Status last verified
- Jun 2026
- First submitted
- 10 Dec 2025
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single-dose, Crossover Bioequivalence Study of TJ101 Injection Before and After CMC Change Following Subcutaneous Injection in Healthy Adult Male Subjects in China
- ClinicalTrials.gov ID
- NCT07300436
- Acronym / sponsor ID
- TJ101001BE102
- Conditions
- Healthy Adult Males in China
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- TJ Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Jan 2026 (actual)
- Primary completion
- 16 Mar 2026 (actual)
- Study completion
- 16 Mar 2026 (actual)
- First posted
- 23 Dec 2025 (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 is Single-center, randomized, open-label, single-dose, two-period crossover study design.
The goal is to preliminary evaluate the PK comparability of TJ101 injection before and after CMC change following a single subcutaneous injection of 1.2 mg/kg in healthy male subjects in China, and to assess whether the two formulations are bio equivalent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A（T-R） | Experimental | Drug: TJ101 injection Test Product, Drug: TJ101 injection Reference Product |
| Group B（R-T） | Experimental | Drug: TJ101 injection Test Product, Drug: TJ101 injection Reference Product |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male subjects aged ≥ 18 and ≤ 45 years;
- Body mass index (BMI): 19-28 kg/m2 (inclusive), weight 50-90 kg (inclusive), with BMI calculated as: BMI = weight (kg) / height2 (m2);
- Results of physical examination, vital signs, laboratory tests, 12-lead ECG, chest X-ray (posteroanterior view), and abdominal B-scan ultrasound are normal or clinically insignificant if abnormal;
- Fully understand the purpose and requirements of this study, voluntarily participate in the clinical study and sign the written informed consent form (ICF), and are able to complete the entire study process as required.
Key exclusion criteria (17 listed)
- (Screening/Admission interview) Known history of allergy to the investigational product, any of its components, or related products; or a history of allergic diseases such as asthma; or allergic diathesis (e.g., known allergy to two or more substances);
- (Screening/Admission interview) A definite history of diseases of the central nervous, cardiovascular, digestive, respiratory, urinary, or hematological systems, or metabolic disorders, or potential underlying diseases that are judged by the investigator to be clinically significant; or other diseases that the investigator considers unsuitable for participation in a clinical study (e.g., history of mental illness);
- (Screening/Admission interview) History of severe infection, severe trauma, or major surgery within 6 months prior to screening;
- (Screening/Admission interview) History of blood donation, blood loss ≥ 400 mL, or blood transfusion (at least one of the above) within 3 months prior to screening; or plan to donate blood within 3 months after the end of the study;
- Positive test for any of the following infectious diseases: human immunodeficiency virus antibody, hepatitis B surface antigen, hepatitis C virus antibody, Treponema pallidum specific antibody, and syphilis specific antibody;
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 |
|---|---|---|
| TJ101 injection Test Product1.2 mg/kg, administered by subcutaneous injection in the abdomen,Once per cycle | Drug | Group A（T-R）, Group B（R-T） |
| TJ101 injection Reference Product1.2 mg/kg, administered by subcutaneous injection in the abdomen,Once per period | Drug | Group A（T-R）, Group B（R-T） |
Primary outcome
Primary PK endpoint: Cmax
Time frame: 10 days after dosing
Maximum Concentration
Primary PK endpoint: AUC0-inf
Time frame: 10 days after dosing
Area Under the Concentration-Time Curve from Time Zero to Infinity
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 24 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TJ101 injection Test Product and TJ101 injection Reference Product in people with Healthy Adult Males in China, run by TJ Biopharma Co., Ltd. at 1 site in China.
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 4 inclusion and 17 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 24 Jun 2026. 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?
Primary PK endpoint: Cmax (time frame: 10 days after dosing). 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?
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 24 Jun 2026.