To Evaluate Recombinant Human Follicle Stimulating Hormone-CTP Fusion Protein Injection or Placebo Combined With Chorionic Gonadotropin for Injection

GeneScience Pharmaceuticals (GenSci)

Status and phase: Not yet enrolling; Phase 3

Conditions: Idiopathic Hypogonadotropic Hypogonadism

Treatments: Drug: recombinant human follicle-stimulating hormone-CTP Fusion protein injection Placebo; Drug: recombinant human follicle-stimulating hormone-CTP Fusion protein injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT06561594

GenSci094-303

Details and patient eligibility

About

This study was conducted to evaluate recombinant human follicle stimulating hormone-CTP fusion protein injection or placebo combined with chorionic gonadotropin for injection

Full description

A multicenter, randomized, double-blind, Phase III clinical study to evaluate the efficacy and safety of recombinant human follicle-stimulating hormone-CTP Fusion protein injection or placebo combined with chorionic gonadotropin for injection to initiate or restore puberty in idiopathic hypogonadotropin hypogonadism in adolescent males aged 14 to 18 years.

Enrollment: 60 estimated patients

Sex: Male

Ages: 14 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The guardian and subject are aware of the study procedures, available alternative treatments, and the risks of participating in the study, and voluntarily sign a written ICF to voluntarily participate in the study.
• Age 14-18 years old (excluding 18 years old) at the time of signing the ICF, with bone age greater than 12 years old.
• Height ≥145cm and body mass index (BMI) < 30kg/m2 when signing ICF.
• Diagnosis of idiopathic or congenital hypogonadotropic hypogonadism.
• The presence of bilateral pre-gonadal onset testis during the screening period: testicular volume <4 mL on each side (determined by ultrasound and evaluated by 2 qualified ultrasound specialists authorized by the researchers of the research center).
• The circulating gonadotropin (Gn) level was low (FSH≤1 IU/L and LH≤1 IU/L) during the screening period, and the peak LH value of GnRH excitation test was ≤4 IU/L.
• Serum testosterone T ≤ 1 ng/mL during the screening period.
• The normal range of other pituitary hormones during the screening period (judged by the researcher).
• Lesions detected by MRI on the head within 3 months before or during screening were normal or determined by the investigator to have no impact on the study.
• Consent to the use of reliable contraception (e.g. abstinence, condoms, etc.) by yourself and your sexual partner during the study period and for 3 months after the study drug treatment.

Exclusion criteria

There is primary hypogonadism (e.g., Klinefelter syndrome).

• Hypogonadotropic hypogonadism caused by tumor, surgery, trauma, infection, or immune factors in the hypothalamic sella or pituitary gland.
• History of unilateral or bilateral cryptorchidism and the presence of clinically significant testicular lesions (orchitis, testicular tumor, testicular torsion, severe varicocele (grade III), testicular atrophy, obstructive azoospermia, etc.).
• Researchers identified uncontrolled endocrine diseases, including thyroid, adrenal diseases, diabetes, etc.
• History of malignant tumors within 5 years prior to the screening period.
• Patients who have received GnRH, gonadotropin or oral androgen (testosterone, etc.) therapy within 1 month before signing ICF, or who have received testosterone undecanoate intramuscular injection therapy within 1 year before signing ICF.
• History of drug or substance abuse within 1 year prior to signing the ICF, drugs known to impair testicular function or affect the production of sex hormones, or alcohol abuse.
• Abnormal liver and kidney function during screening, i.e. liver function: alanine aminotransferase and/or aspartate aminotransferase higher than 2 times the upper limit of normal (>2×Upper limit of normal); Renal function: Creatinine and/or urea/urea nitrogen are 2 times higher than the upper limit of normal (>2×Upper limit of normal).
• During the screening period, patients with systemic diseases (such as metabolic abnormalities, circulatory, digestive, nervous system, etc.) judged by the researchers are not suitable for participation in this study.
• Current thromboembolic disease or known prior history.
• Hepatitis B surface antigen, hepatitis C antibody, HIV antibody and treponema pallidum antibody positive.●
• People who are allergic to the active ingredients or excipients of FSH and hCG drugs or have a history of related allergies, or have a clear contraindication of drug use.
• Participants who participated in other interventional clinical trials and used experimental drugs within 3 months prior to screening.
• Patients with a history of depression or mental disorders.
• Due to risk considerations, the researchers did not consider it appropriate to participate in other situations in this study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Experimental group

Experimental group

Description:

30subjects：GenSci094 was administered for 12 weeks，150ug/0.5ml（weight\>60kg）or 100ug/0.5ml（weight≤60kg）；GenSci094 with chorionic gonadotropin for injection was administered for 52 weeks，150ug/0.5ml（weight\>60kg）or 100ug/0.5ml（weight≤60kg）with chorionic gonadotropin for injection.

Treatment:

Drug: recombinant human follicle-stimulating hormone-CTP Fusion protein injection

Placebo group

Placebo Comparator group

Description:

30subjects：GenSci094 Placebo was administered for 12 weeks，150ug/0.5ml（weight≥60kg）or 100ug/0.5ml（weight\<60kg）；GenSci094 Placebo with chorionic gonadotropin for injection was administered for 52 weeks，150ug/0.5ml（weight≥60kg）or 100ug/0.5ml（weight\<60kg）with chorionic gonadotropin for injection.

Treatment:

Drug: recombinant human follicle-stimulating hormone-CTP Fusion protein injection Placebo