None listed
Conditions
Brief summary
This is a phase 1, open-label, study to evaluate the safety, pharmacokinetics, and pharmacodynamics 225 IU GB-hMG over 7 consecutive days in healthy premenopausal women. Up to twenty eligible, healthy volunteers will receive one (1) subcutaneous (SC) injection of 225 international units (IU) per day for seven (7) consecutive days to evaluate the safety, pharmacokinetics, and pharmacodynamics of GB-hMG.
Interventions
This is a phase 1, open-label, study to evaluate the safety, pharmacokinetics, and pharmacodynamics 225 IU GB-hMG over 7 consecutive days in healthy premenopausal women.
Twenty eligible, healthy volunteers will receive one (1) daily subcutaneous (SC) injection of 225 international units (IU) of GB-hMG for seven (7) days.
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
This is a phase 1, open-label, study to evaluate the safety, pharmacokinetics, and pharmacodynamics 225 IU GB-hMG over 7 consecutive days in healthy premenopausal women. Twenty eligible, healthy volunteers will receive one (1) daily subcutaneous (SC) injection of 225 international units (IU) of GB-hMG for seven (7) days. 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).
Sponsors
Accelagen Pty Ltd
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 42 Years
Healthy volunteers
Yes
Inclusion criteria
Participants will be eligible for enrolment in the study only if they meet ALL the following criteria at time of Screening: 1. 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. 2. 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. 3. Participants will have a Body Mass Index (BMI) of 18-38 kg/m2. 4. Participants will have regular menstrual cycles of 24-35 days, as confirmed by participant and documented in the source documentation. 5. Participants will have a negative Cervical Screening Test or Pap Smear within 5 years (if human papillomavirus [HPV] vaccinated) or within 3 years (if not vaccinated against HPV). 6. Currently using or assessed as suitable and willing to initiate a 3-week course of active combined oral contraceptive pills (COCPs) containing estrogen and progestogen prior to receiving GnRH agonist. 7. Participants will have a baseline transvaginal ultrasound (TVUS) showing no ovarian follicles or cysts greater than or equal to 11 mm prior to receiving ZOLADEX (Day -12) and prior to check-in (Day -1, window: -3 days) following GnRH agonist treatment period or as determined as sufficiently suppressed by investigator and approved by Sponsor Medical Monitor. 8. On Day -1, participants must demonstrate adequate pituitary suppression, generally defined as, or as determined as sufficiently suppressed by investigator and approved by Sponsor Medical Monitor: a. Serum FSH levels less than or equal to 4 IU/L b. Serum oestradiol (E2) levels less than or equal to 183.5 pmol/L c. Serum progesterone (P4) levels less than 3.18 nmol/L 9. 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 30. 10. Participants will not be lactating and must test negative for pregnancy prior to COCP and before and after receiving GnRH agonist. 11. Participants must use effective methods of non-hormonal contraception once they pass screening and agree to participate
Exclusion criteria
Participants meeting ANY of the following criteria at time of Screening will be excluded from enrolment: 1. Any concomitant disease or condition, 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 (including migraine), oncologic, and psychiatric disease (except for mild depression and anxiety). 2. History of (or current) endocrine abnormalities such as hyperprolactinaemia, polycystic ovary syndrome, and any evidence of ovarian dysfunction. 3. 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. Participants with documented medical authorization for cannabis and/or prescription use of ADHD medications (e.g., methamphetamine-based treatments) are allowed. 4. 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 30. 5. 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. 6. Use of medications that will interfere with COCP metabolism including antibiotics, anticonvulsants, antifungals, and herbal supplements (during COCP treatment phase). 7. Any contraindication or hypersensitivity to gonadotropin, GnRH agonist therapy, or COCPs or any formulation components thereof. 8. Any tattoos or scars that might impact assessment of incident severity rating, as judged by the Investigator. 9. Participant is pregnant or lactating or intending to become pregnant or donate oocytes before, during, or within 28 days after receiving GB-hMG. 10. 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. 11. Impaired renal function as determined by the Investigator, based on an estimated eGFR less than 90 mL/min/1.73 m2 at Screening. 12. 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). 13. Participants must test negative for hepatitis B surface antigen, hepatitis C antibodies, and HIV-1 and HIV-2 antibodies at Screening. 14. 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. 15. Participants must not have fever (body temperature greater than 37.7°C) within 2 days of receiving study intervention. 16. 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. 17. 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.
Outcome results
None listed