ClinicalTrialsFinder
RecruitingPhase 1ACTRN12624001371583

A Phase 1 Safety and Pharmacokinetics Study of GB-hMG in Healthy Women

A Phase 1, Single Dose Study to Evaluate the Safety and Pharmacokinetics of GB-hMG (Menotropins) for Subcutaneous Injection in Healthy Premenopausal Women

Sponsor

Accelagen Pty Ltd

Enrollment

30 participants

Start Date

Oct 25, 2024

Study Type

Interventional

Conditions

Infertility

Summary

This is a phase 1, open-label, randomised, multi-centre study to evaluate the safety, immunogenicity, pharmacokinetics, and pharmacodynamics of a single administration of GB-hMG in healthy premenopausal females. Thirty eligible, healthy volunteers will be randomised to one of four single doses and receive one (1) subcutaneous (SC) injection of 150 international units (IU), 225 IU, 300 IU, or 450 IU, to evaluate the pharmacokinetics and dose proportionality of GB-hMG. GB-hMG contains follicle stimulating hormone (FSH), luteinizing hormone (LH) and human chorionic gonadotropin (hCG). FSH, hCG and LH are produced by your body as part of your regular hormonal cycles. It is thought that GB-hMG will be able to stimulate the ovaries to increase fertility and ability to produce healthy ova.

Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 42 Yearss

Inclusion Criteria45

  • Healthy pre-menopausal female volunteers (18-42 years old) that will undergo pituitary suppression as part of the study. Healthy status will be determined by the Investigator based on medical history, gynaecological examinations, clinical laboratory results, vital signs, electrocardiogram measurements, and physical examination at Screening.
  • Participants willing and able to give personal signed informed consent and comply with all scheduled visits, drug administration plan, laboratory tests, lifestyle considerations, and other study procedures.
  • Participants will have a Body Mass Index (BMI) of 18-38 kg/m2
  • Participants will have regular menstrual cycles of 24-35 days, as confirmed by participant and documented in the source documentation.
  • Participants will have a negative Cervical Screening Test or Pap Smear within 5 years if human papillomavirus (HPV) vaccinated or 3 years if not HPV vaccinated.
  • Participants will be taking an oral contraceptive pill (OCP) or be assessed as suitable and willing to take an OCP for a period of 2 weeks prior to receiving GnRH agonist.
  • Participants will have a Baseline transvaginal ultrasound (TVUS) showing no ovarian follicles/cysts greater than 11 mm after receiving OCPs (Day -11) and prior to check-in after conclusion of GnRH agonist treatment period (Day -1; window -3 days) or as determined as sufficiently suppressed by investigator and approved by Sponsor Medical Monitor.
  • Participants will have Baseline (Day -1) serum FSH levels less than 4 IU/L, estradiol (E2) levels less than or equal to 50 pg/mL, and progesterone (P4) levels less than 1 ng/mL prior to receiving GB-hMG.
  • Participants who smoke no more than 2 cigarettes per day or equivalent per week (including e-cigarettes) can be included in the study. Note: Participants must discontinue smoking/use of nicotine-containing products from 48 hours before first study drug administration through Day 14.
  • Participants will not be lactating and must test negative for pregnancy prior to OCP and before and after receiving GnRH agonist.
  • Participants must use effective methods of contraception once they pass screening and agree to participate and at conclusion of the study as outlined below:
  • Prior to Screening and until Day -26 (use method A or B below):
  • A. Established use of oral hormonal methods of contraception, and
  • I. A barrier method (i.e., condom or diaphragm)
  • II. Male partner vasectomised at least 6 months prior to the Screening visit (the partner is the sole sexual partner of the woman of childbearing potential and the
  • vasectomised partner has received medical assessment of the surgical success
  • (verbal confirmation of male partner/s vasectomy is acceptable)
  • III. Abstinence
  • B. Non-hormonal intrauterine device (IUD)/ intrauterine system (IUS), and
  • I. A barrier method (i.e., condom or diaphragm)
  • II. Male partner vasectomised at least 6 months prior to the Screening visit (the partner is the sole sexual partner of the woman of childbearing potential and the
  • vasectomised partner has received medical assessment of the surgical success (verbal confirmation of male partner/s vasectomy is acceptable)
  • III. Abstinence
  • Pretreatment (OCP) Day -25 to Day -12
  • A. OCP, and
  • I. A barrier method (i.e., condom or diaphragm)
  • II. Male partner vasectomised at least 6 months prior to the Screening visit (the partner is the sole sexual partner of the woman of childbearing potential and the
  • vasectomised partner has received medical assessment of the surgical success (verbal confirmation of male partner/s vasectomy is acceptable)
  • III. Abstinence
  • On Study Day -11 to Day 14 (use methods A, B, C, or D below):
  • A. Non-hormonal IUD/IUS
  • B. Male partner vasectomised at least 6 months prior to the Screening visit (the partner is the sole sexual partner of the woman of childbearing potential and the vasectomised partner has received medical assessment of the surgical success (verbal confirmation of male partner/s vasectomy is acceptable)
  • C. Abstinence
  • D. A barrier method (i.e., condom or diaphragm)
  • Post EOS/Day 14:
  • From Day 14 until 28 days after receiving GB-hMG, the participant may return to using hormonal contraception including having an IUD/IUS inserted, depot injection per the following options (A or B):
  • A. OCP, and
  • I. A barrier method (i.e., condom or diaphragm)
  • II. Male partner vasectomised at least 6 months prior to the Screening visit (the partner is the sole sexual partner of the woman of childbearing potential and the
  • vasectomised partner has received medical assessment of the surgical success (verbal confirmation of male partner/s vasectomy is acceptable)
  • III. Abstinence
  • B. Non-hormonal or hormonal IUD/ IUS, and
  • I. A barrier method (i.e., condom or diaphragm)
  • II. Male partner vasectomised at least 6 months prior to the Screening visit (the partner is the sole sexual partner of the woman of childbearing potential and the vasectomised partner has received medical assessment of the surgical success (verbal confirmation of male partner/s vasectomy is acceptable)
  • III. Abstinence

Exclusion Criteria21

  • Any concomitant disease, condition, or treatment that could interfere with the conduct of the study, or that would, in the opinion of the Investigator or Sponsor, pose an unacceptable risk to the participant in the study or interfere with the interpretation of study data. Particular attention should be given to history or evidence of clinically significant cardiovascular, pulmonary (except for resolved childhood asthma), hepatic, renal, haematologic, gastrointestinal, endocrine, immunologic, autoimmune diseases, dermatologic, neurologic, oncologic, and psychiatric disease (except for mild depression and anxiety).
  • History of (or current) endocrine abnormalities such as hyperprolactinaemia, polycystic ovary syndrome, and any evidence of ovarian dysfunction.
  • Positive alcohol breath test and/or urine drug test. The urine drug test will be considered positive if any of the following are detected in the urine: Methamphetamine, opiates,
  • cocaine, cannabis, phencyclidine, benzodiazepines, barbiturates, methadone, tricyclic antidepressants, and amphetamine.
  • Regular alcohol consumption defined as greater than 21 alcohol units per week (where 1 unit = 284 mL of beer, 25 mL of 40% spirit or a 125 mL glass of wine). Participant is unwilling to abstain from alcohol beginning 48 hours prior to admission to the CRU through Day 14.
  • Uncontrolled hypertension or blood pressures defined as systolic blood pressure (BP) greater than 130 mmHg or less than 90 mmHg and/or diastolic BP greater than 80 mmHg or less than 50 mmHg. Blood pressure and heart rate will be measured in a sitting position following 5 minutes rest. Two repeats will be allowed at the discretion of the Investigator. Please note that BP well controlled with BP lowering agents is allowed at the discretion of the Investigator.
  • Use of medications that will interfere with OCP metabolism including antibiotics, anticonvulsants, antifungals, and herbal supplements (during OCP treatment phase).
  • Any contraindication or hypersensitivity to gonadotropin, GnRH agonist therapy, or OCPs or any formulation components thereof.
  • Any tattoos or scars that might impact assessment of incident severity rating, as judged by the Investigator.
  • Participant is pregnant or lactating or intending to become pregnant or donate ova before, during, or within 28 days after receiving GB-hMG.
  • Participants must have clinical laboratory values within normal ranges or less than 3 times upper limit of normal (ULN) as specified by the testing laboratory, unless deemed not clinically significant (NCS) by the Investigator. Repeat testing at Screening is acceptable once more if it is not less than two weeks or not more than two months afterward for out-of-range values following approval by the Investigator or delegate.
  • Impaired renal function as determined by the Investigator, based on an estimated eGFR less than 90 mL/min/1.73 m2 at Screening.
  • Has an established diagnosis of Type 1 or Type 2 diabetes mellitus, as indicated by use of diabetes medication, HbA1C greater than 6.4% or fasting glucose greater than or equal to 97.3 mg/dL (5.4 mmol/L).
  • Participants must test negative for hepatitis B surface antigen, hepatitis C antibodies, and HIV-1 and HIV-2 antibodies at Screening.
  • Active malignancy and/or history of malignancy in the past 5 years, with the exception of completely excised non-melanoma skin cancer or low grade cervical intraepithelial
  • neoplasia.
  • Participants must not have fever (body temperature greater than 37.7°C) within 2 days of receiving study intervention.
  • Participant has received any experimental drug within 30 days and/or 5 half-lives of the experimental drug, whichever is longer, prior to Screening. Participants who are off
  • treatment of the experimental drug and are on observation/long term follow up will be considered on a case-by-case basis.
  • Participant has donated or lost 470 mL or more of his or her blood volume (including plasmapheresis) or had a transfusion of any blood product within 12 weeks prior to
  • Screening

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

This is a phase 1, open-label, randomised, mutli-centre study to evaluate the safety, immunogenicity, pharmacokinetics, and pharmacodynamics of a single administration of GB-hMG in healthy premenopaus

This is a phase 1, open-label, randomised, mutli-centre study to evaluate the safety, immunogenicity, pharmacokinetics, and pharmacodynamics of a single administration of GB-hMG in healthy premenopausal females. Thirty eligible, healthy volunteers will be randomised to one of four single doses and receive one (1) subcutaneous (SC) injection of 150 international units (IU), 225 IU, 300 IU, or 450 IU, to evaluate the pharmacokinetics and dose proportionality of GB-hMG. The dose will be administered via SC injection into the abdomen by an appropriately qualified, Good Clinical Practice (GCP)-trained, and experienced member of the study staff. Participants will remain under observation at the CRU for 2 days after administration of study drug and will be discharged only after review by the Investigator (i.e., Study Day 3).

Locations(1)

University of the Sunshine Coast Clinical Trials Centre - Sippy Downs - Sippy Downs

QLD,SA, Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12624001371583

Related Trials

A Study to Compare the Efficacy and Safety of Follitropin Alfa/Lutropin Alfa Versus hMG in Japanese Participants With LH and FSH Deficiency Undergoing ART (HINATA)

NCT0734082711 locations

A Large-scale, Prospective Cohort Study Was Conducted to Explore the Association Between Environmental Exposure and Behavioral Factors and Infertility (the Success Rate of Assisted Reproductive Technology)

NCT076413871 location

Inherited Reproductive Disorders

NCT015004472 locations

Biorepository in Participants Who Undergo OTC for Gonadotoxic Therapy

NCT054406171 location

Fertility Preservation Using Tamoxifen and Letrozole in Estrogen Sensitive Tumors Trial

NCT030116841 location