InfertilityPhase 1NCT06095206
The Pharmacokinetic and Bioavailability of GenSci094 Before and After a Change in Manufacturing Site
A Phase 1 study testing GenSci094 in people with Infertility, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The bioavailability study is intended to evaluate the pharmacokinetic (PK) characteristics and the bioavailability of the two formulations in humans before and after the change of production site, in order to assess the possible impact of the site change on the pharmacokinetic characteristics of the drug and to… 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
- Infertility
- What is being tested?
- GenSci094
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 19 Sep 2023to 13 Nov 2023
- 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
- Subjects volunteered and signed an informed consent form and were able to understand and follow the trial requirements;
- Healthy males aged 18-45 years old (including cut-off values);
- Body weight ≥60kg and BMI between 19-28 kg/m2 (including cut-off values);
- The subject's clinical history, physical examination, 12-lead electrocardiogram and laboratory tests during the screening period were not abnormal or the abnormalities were not clinically significant.
- The subject agrees to use reliable contraception for himself/herself and his/her partner for the duration of the study and for a period of 3 months after study drug infusion.
Who cannot join
- Persons with clinically significant metabolic/endocrine, hepatic, renal, hematologic, pulmonary, immunologic, cardiovascular, gastrointestinal, genitourinary, neurologic, or psychiatric disorders of any clinical severity or any other condition capable of interfering with the results of the test (at the discretion of the investigator) within the 3 months prior to the Screening Period and during the Screening Period;
- Abnormalities in basic sex hormone tests of clinical significance (at the discretion of the investigator)
- Abnormal liver function: alanine aminotransferase (ALT) or alanine transaminase (AST) > 1.5 times the upper limit of normal, or total bilirubin > 1.3 times the upper limit of normal;
- Thromboembolic disease or history;
- Those with a clear history of neurologic or psychiatric disorders (including epilepsy, dementia, depression or bipolar disorder, schizophrenia, etc.);
- Prior history of gastrointestinal surgery, renal surgery, cholecystectomy, and other surgical procedures that, in the judgment of the investigator, may affect drug absorption or excretion;
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- Known history of allergy, anaphylaxis or hypersensitivity to the test preparation and any of its components or related agents;
- Previous intolerance to phlebotomy/indwelling needle blood collection or history of blood or needle sickness;
- Hypertension: systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg;
- Positive screening tests for Hepatitis B Surface Antigen, Hepatitis C Virus Antibody, Human Immunodeficiency Virus (HIV) Antibody, or Treponema pallidum Antibody;
- Those who have smoked >5 cigarettes per day in the 3 months prior to screening, or who are unable to abstain from the use of any tobacco-based products during the trial period;
- Persons with drug dependence or drug abuse within 1 year prior to dosing, or who have a positive combined urine multi-drug test at check-in;
- Those who have donated blood or lost ≥ 400 mL of blood within 3 months prior to the first dose; those who have difficulty collecting blood intravenously; and those who plan to donate blood during the trial or within 1 month of the end of the study;
- Regular use of any prescription drug, over-the-counter drug, biologic, proprietary medicine, herbal medicine, vitamin dietary supplement or maintenance product, or vaccine within 2 weeks prior to the first dose, except for oral or buried long-acting contraceptives;
- Persons who have been treated with any investigational drug or medical device in a clinical trial within 3 months prior to the first dose;
Trial locations and contacts
1 site in 1 country.
China1 site
Chengdu Xinhua Hospital, affiliated with Sichuan North Medical College
Chengdu, Sichuan
About this study
Official title: to Evaluate the Pharmacokinetic Characteristics and Bioavailability of Recombinant Human Follicle Stimulating Hormone-CTP Fusion Protein Injection（GenSci094） in Healthy Male Subjects Before and After a Change in Manufacturing Site
The bioavailability study is intended to evaluate the pharmacokinetic (PK) characteristics and the bioavailability of the two formulations in humans before and after the change of production site, in order to assess the possible impact of the site change on the pharmacokinetic characteristics of the drug and to clarify whether the two formulations are comparable before and after the change.
Read the detailed description
This study used a single-center, open, randomized, single-dose, parallel-controlled trial design, and the study drug consisted of 1) the test drug (GenSci094 after the change in manufacturing site) and 2) the control drug (GenSci094 before the change in manufacturing site). Screened 48 healthy male subjects were randomly assigned to Group A (test drug) or Group B (control drug), randomized at timeprevious day（ D-1）, admitted to the Phase I clinical trial ward and put on a uniform diet; received 150 μg subcutaneous injection administration of the study drug on the following day (D1), and blood was collected for PK and immunogenicity up today 18（ D18）; and completed a safety telephone follow-up on day 25（D25）.
- Conditions
- Infertility
- Being tested
- GenSci094
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GenSci094Drug
On the morning of day 1 pre-meal, a single SC injection of 150 μg GenSci094 was administered in the abdominal wall.
| Study group | Role | What they receive |
|---|---|---|
| GenSci094 | Experimental | Participants received a single subcutaneous (SC) injection of 150 µg GenSci094 on day 1 pre-meal，PK and immunogenicity blood collection to day18， safety call follow-up completed at day 25 Receives: Drug: GenSci094 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax（Maximum Serum Concentration of GenSci094(Cmax)
Measured: Venous blood was collected at 16 time points: 2h before, 6h, 12h, 24h, 30h, 36h, 48h (D3), 54h, 60h, 72h (D4), 96h (D5), 120h (D6), 192h (D9), 264h (D12), 336h (D15), and 408h (D18) for the determination of the concentration of GenSci094 in serum.
AUC0-t（（area under the time curve of blood concentration at time from 0 to the last time point selected
Measured: Venous blood was collected at 16 time points: 2h before, 6h, 12h, 24h, 30h, 36h, 48h (D3), 54h, 60h, 72h (D4), 96h (D5), 120h (D6), 192h (D9), 264h (D12), 336h (D15), and 408h (D18) for the determination of the concentration of GenSci094 in serum.]
AUC0-∞（Area Under the Serum Concentration-time Curve Extrapolated to Infinity [AUC(0-∞)
Measured: Venous blood was collected at 16 time points: 2h before, 6h, 12h, 24h, 30h, 36h, 48h (D3), 54h, 60h, 72h (D4), 96h (D5), 120h (D6), 192h (D9), 264h (D12), 336h (D15), and 408h (D18) for the determination of the concentration of GenSci094 in serum.
Tmax（Time to Reach a Maximum GenSci094 Serum Concentration (Tmax)
Measured: Venous blood was collected at 16 time points: 2h before, 6h, 12h, 24h, 30h, 36h, 48h (D3), 54h, 60h, 72h (D4), 96h (D5), 120h (D6), 192h (D9), 264h (D12), 336h (D15), and 408h (D18) for the determination of the concentration of GenSci094 in serum.
T1/2（GenSci094 Apparent Terminal Half-life (T1/2)
Measured: Venous blood was collected at 16 time points: 2h before, 6h, 12h, 24h, 30h, 36h, 48h (D3), 54h, 60h, 72h (D4), 96h (D5), 120h (D6), 192h (D9), 264h (D12), 336h (D15), and 408h (D18) for the determination of the concentration of GenSci094 in serum.
Safety and tolerability: Evaluation of safety through the adverse affects investigation
Measured: The entire study period begins when the subject signs the written ICF and ends with the completion of the last visit
Laboratory tests，physical examination，Post-medication results were analyzed for descriptive statistics on change from baseline values
Measured: 0-408hours
12-lead ECG：Heart rate, PR interval, QRS, QTc interval，Post-medication results were analyzed for descriptive statistics on change from baseline values
Measured: 0-408hours
Secondary outcomes (1)
Immunogenicity: Anti-drug antibody (ADA)
Measured: Immunogenicity blood sample collection time points: within 1h before drug administration, 192h (D9), 408h (D18) for a total of 3 time points, and venous blood collected for serum immunogenicity analysis evaluation during early withdrawal visits]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start19 Sep 2023
- Primary completion7 Nov 2023
- Study completion13 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Changchun GeneScience Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Affiliated Hospital of North Sichuan Medical College
- Responsible party
- Sponsor
- Investigators
- Xiaolan Yong, bachelor, Study chair, chengdu xinhua hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06095206
- Sponsor's protocol ID
- GenSci094-101
- Status last verified
- Dec 2024
- First submitted
- 11 Oct 2023
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- to Evaluate the Pharmacokinetic Characteristics and Bioavailability of Recombinant Human Follicle Stimulating Hormone-CTP Fusion Protein Injection（GenSci094） in Healthy Male Subjects Before and After a Change in Manufacturing Site
- ClinicalTrials.gov ID
- NCT06095206
- Acronym / sponsor ID
- GenSci094-101
- Conditions
- Infertility
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Affiliated Hospital of North Sichuan Medical College
- Study start
- 19 Sep 2023 (actual)
- Primary completion
- 7 Nov 2023 (actual)
- Study completion
- 13 Nov 2023 (actual)
- First posted
- 23 Oct 2023 (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.
The bioavailability study is intended to evaluate the pharmacokinetic (PK) characteristics and the bioavailability of the two formulations in humans before and after the change of production site, in order to assess the possible impact of the site change on the pharmacokinetic characteristics of the drug and to clarify whether the two formulations are comparable before and after the change.
Detailed description
This study used a single-center, open, randomized, single-dose, parallel-controlled trial design, and the study drug consisted of 1) the test drug (GenSci094 after the change in manufacturing site) and 2) the control drug (GenSci094 before the change in manufacturing site). Screened 48 healthy male subjects were randomly assigned to Group A (test drug) or Group B (control drug), randomized at timeprevious day（ D-1）, admitted to the Phase I clinical trial ward and put on a uniform diet; received 150 μg subcutaneous injection administration of the study drug on the following day (D1), and blood was collected for PK and immunogenicity up today 18（ D18）; and completed a safety telephone follow-up on day 25（D25）.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GenSci094 | Experimental | Drug: GenSci094Participants received a single subcutaneous (SC) injection of 150 µg GenSci094 on day 1 pre-meal，PK and immunogenicity blood collection to day18， safety call follow-up completed at day 25 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subjects volunteered and signed an informed consent form and were able to understand and follow the trial requirements;
- Healthy males aged 18-45 years old (including cut-off values);
- Body weight ≥60kg and BMI between 19-28 kg/m2 (including cut-off values);
- The subject's clinical history, physical examination, 12-lead electrocardiogram and laboratory tests during the screening period were not abnormal or the abnormalities were not clinically significant.
- The subject agrees to use reliable contraception for himself/herself and his/her partner for the duration of the study and for a period of 3 months after study drug infusion.
Key exclusion criteria (15 listed)
- Persons with clinically significant metabolic/endocrine, hepatic, renal, hematologic, pulmonary, immunologic, cardiovascular, gastrointestinal, genitourinary, neurologic, or psychiatric disorders of any clinical severity or any other condition capable of interfering with the results of the test (at the discretion of the investigator) within the 3 months prior to the Screening Period and during the Screening Period;
- Abnormalities in basic sex hormone tests of clinical significance (at the discretion of the investigator)
- Abnormal liver function: alanine aminotransferase (ALT) or alanine transaminase (AST) > 1.5 times the upper limit of normal, or total bilirubin > 1.3 times the upper limit of normal;
- Thromboembolic disease or history;
- Those with a clear history of neurologic or psychiatric disorders (including epilepsy, dementia, depression or bipolar disorder, schizophrenia, etc.);
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 |
|---|---|---|
| GenSci094On the morning of day 1 pre-meal, a single SC injection of 150 μg GenSci094 was administered in the abdominal wall. | Drug | GenSci094 |
Primary outcome
Cmax（Maximum Serum Concentration of GenSci094(Cmax)
Time frame: Venous blood was collected at 16 time points: 2h before, 6h, 12h, 24h, 30h, 36h, 48h (D3), 54h, 60h, 72h (D4), 96h (D5), 120h (D6), 192h (D9), 264h (D12), 336h (D15), and 408h (D18) for the determination of the concentration of GenSci094 in serum.
AUC0-t（（area under the time curve of blood concentration at time from 0 to the last time point selected
Time frame: Venous blood was collected at 16 time points: 2h before, 6h, 12h, 24h, 30h, 36h, 48h (D3), 54h, 60h, 72h (D4), 96h (D5), 120h (D6), 192h (D9), 264h (D12), 336h (D15), and 408h (D18) for the determination of the concentration of GenSci094 in serum.]
AUC0-∞（Area Under the Serum Concentration-time Curve Extrapolated to Infinity [AUC(0-∞)
Time frame: Venous blood was collected at 16 time points: 2h before, 6h, 12h, 24h, 30h, 36h, 48h (D3), 54h, 60h, 72h (D4), 96h (D5), 120h (D6), 192h (D9), 264h (D12), 336h (D15), and 408h (D18) for the determination of the concentration of GenSci094 in serum.
Tmax（Time to Reach a Maximum GenSci094 Serum Concentration (Tmax)
Time frame: Venous blood was collected at 16 time points: 2h before, 6h, 12h, 24h, 30h, 36h, 48h (D3), 54h, 60h, 72h (D4), 96h (D5), 120h (D6), 192h (D9), 264h (D12), 336h (D15), and 408h (D18) for the determination of the concentration of GenSci094 in serum.
T1/2（GenSci094 Apparent Terminal Half-life (T1/2)
Time frame: Venous blood was collected at 16 time points: 2h before, 6h, 12h, 24h, 30h, 36h, 48h (D3), 54h, 60h, 72h (D4), 96h (D5), 120h (D6), 192h (D9), 264h (D12), 336h (D15), and 408h (D18) for the determination of the concentration of GenSci094 in serum.
Safety and tolerability: Evaluation of safety through the adverse affects investigation
Time frame: The entire study period begins when the subject signs the written ICF and ends with the completion of the last visit
Laboratory tests，physical examination，Post-medication results were analyzed for descriptive statistics on change from baseline values
Time frame: 0-408hours
12-lead ECG：Heart rate, PR interval, QRS, QTc interval，Post-medication results were analyzed for descriptive statistics on change from baseline values
Time frame: 0-408hours
1 secondary outcome
Immunogenicity: Anti-drug antibody (ADA)
Time frame: Immunogenicity blood sample collection time points: within 1h before drug administration, 192h (D9), 408h (D18) for a total of 3 time points, and venous blood collected for serum immunogenicity analysis evaluation during early withdrawal visits]
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 3 Dec 2024.
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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.
Xiaolan Yong, bachelor study chair
chengdu xinhua hospital
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 GenSci094 in people with Infertility, run by Changchun GeneScience Pharmaceutical 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 5 inclusion and 15 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 3 Dec 2024. 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?
Cmax（Maximum Serum Concentration of GenSci094(Cmax) (time frame: Venous blood was collected at 16 time points: 2h before, 6h, 12h, 24h, 30h, 36h, 48h (D3), 54h, 60h, 72h (D4), 96h (D5), 120h (D6), 192h (D9), 264h (D12), 336h (D15), and 408h (D18) for the determination of the concentration of GenSci094 in serum.). The study lists 8 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 3 Dec 2024.