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The Pharmacokinetic and Bioavailability of GenSci094 Before and After a Change in Manufacturing Site

Primary Purpose

Infertility

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
GenSci094
Sponsored by
Changchun GeneScience Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Infertility

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion criteria 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. Exclusion criteria 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; 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;

Sites / Locations

  • Chengdu Xinhua Hospital, affiliated with Sichuan North Medical CollegeRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GenSci094

Arm Description

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

Outcomes

Primary Outcome Measures

Cmax(Maximum Serum Concentration of GenSci094(Cmax)
AUC0-t((area under the time curve of blood concentration at time from 0 to the last time point selected
AUC0-∞(Area Under the Serum Concentration-time Curve Extrapolated to Infinity [AUC(0-∞)
Tmax(Time to Reach a Maximum GenSci094 Serum Concentration (Tmax)
T1/2(GenSci094 Apparent Terminal Half-life (T1/2)
Safety and tolerability: Evaluation of safety through the adverse affects investigation
Laboratory tests,physical examination,Post-medication results were analyzed for descriptive statistics on change from baseline values
12-lead ECG:Heart rate, PR interval, QRS, QTc interval,Post-medication results were analyzed for descriptive statistics on change from baseline values

Secondary Outcome Measures

Immunogenicity: Anti-drug antibody (ADA)

Full Information

First Posted
October 11, 2023
Last Updated
October 18, 2023
Sponsor
Changchun GeneScience Pharmaceutical Co., Ltd.
Collaborators
Affiliated Hospital of North Sichuan Medical College
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1. Study Identification

Unique Protocol Identification Number
NCT06095206
Brief Title
The Pharmacokinetic and Bioavailability of GenSci094 Before and After a Change in Manufacturing Site
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 19, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Changchun GeneScience Pharmaceutical Co., Ltd.
Collaborators
Affiliated Hospital of North Sichuan Medical College

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GenSci094
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
GenSci094
Intervention Description
On the morning of day 1 pre-meal, a single SC injection of 150 μg GenSci094 was administered in the abdominal wall.
Primary Outcome Measure Information:
Title
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.
Title
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.]
Title
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.
Title
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.
Title
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.
Title
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
Title
Laboratory tests,physical examination,Post-medication results were analyzed for descriptive statistics on change from baseline values
Time Frame
0-408hours
Title
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
Secondary Outcome Measure Information:
Title
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]

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Referring to the Chinese Pharmacopoeia 2020 edition of four general rules 9011 "Guidelines for human bioavailability and bioequivalence testing of pharmaceutical preparations", since GenSci094 is an FSH class drug, To ensure the safety of healthy female subjects, healthy males were selected as the subjects of this study to avoid GnRH agonist introduction and to reduce the risk of subjects, while only one dose of the drug was administered in this study and sex hormone was tested before and after the administration of the drug in male subjects
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria 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. Exclusion criteria 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; 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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ShuQin Jiang, bachelor
Phone
18036617122
Email
jiangshuqin@gensci-china.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaolan Yong, bachelor
Organizational Affiliation
chengdu xinhua hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Chengdu Xinhua Hospital, affiliated with Sichuan North Medical College
City
Chengdu,
State/Province
Sichuan
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

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The Pharmacokinetic and Bioavailability of GenSci094 Before and After a Change in Manufacturing Site

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