Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000632493p
Ethics application status
Submitted, not yet approved
Date submitted
20/05/2025
Date registered
16/06/2025
Date last updated
16/06/2025
Date data sharing statement initially provided
16/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase 1 Safety and Pharmacokinetics Multi Dose Study of GB-hMG in Healthy Women
Scientific title
A Phase 1, Multi Dose Study to Evaluate the Safety and Pharmacokinetics of GB-hMG (Menotropins) for Subcutaneous Injection in Healthy Premenopausal Women
Secondary ID [1] 314334 0
GBHMG-102
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infertility 337301 0
Condition category
Condition code
Reproductive Health and Childbirth 333690 333690 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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).
Intervention code [1] 330948 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341560 0
To assess the safety and tolerability profile of daily subcutaneous administration of 225 IU GB-hMG for 7 days in healthy premenopausal women
Timepoint [1] 341560 0
• All AEs and SAEs will be collected from informed consent until Day 30 post-first dose. • The injection site will be checked at -1 hours pre-dose, 1, 2, 4, 6, 8, 12, 16, 18, 22, and 24 hours post-first dose. Additional injection site assessments will be performed at 48, 72, 96, 120, 144, and 168 hours post-first dose with a final injection site assessment performed on Day 9 at 192 hours post-first dose. • Vital Signs will be checked at Pre-dose (-1.5), 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 312, and 696 hours post-first dose. • A complete physical examination at Screening and an abbreviated physical examination will be conducted on Day -1 (heart, lungs, abdomen, and skin). On all other study days where physical examination is required, a symptom-directed physical examination, under the discretion of the Investigator or delegate, will be performed. • A 12-lead ECG at Screening and Day –1. • Safety labs at pre-dose –1h, 24, 48, 72, 96, 120, 144, 696 hours post-first dose..
Primary outcome [2] 341561 0
To characterize the pharmacokinetic profile of GB-hMG over multiple doses.
Timepoint [2] 341561 0
PK: Pre-dose -1h, -0.5h, -0.1h, 1h, 2h, 4h, 6h, 8h, 12h, 16h, 18h, 20h, 22h, 24h, 48h, 72h, 96h, 120h, 144h, 145h, 146h, 148h, 150h, 152h, 156h, 160h, 162h, 164h, 166h, 168h, 172h, 176h, 180h, 184h, 188h, and 192h hours post-first dose
Primary outcome [3] 341659 0
To characterize the pharmacodynamic profile of GB-hMG over multiple doses
Timepoint [3] 341659 0
E2: Pre-dose -1h, 1h, 2h, 4h, 8h, 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h, 192h and 312h hours post-first dose TVUS: Pre-dose, dosing day 5, dosing day 9
Secondary outcome [1] 447931 0
Exploratory Endpoint: To investigate the immunogenicity profile of GB-hMG after repeated administration in healthy premenopausal women
Timepoint [1] 447931 0
Blood sample collected on Day 1 (baseline screening, timepoint not defined as it can be any time before Study Drug administration), Day 14 (312 h), and Day 30 (696h) post-first dose.
Secondary outcome [2] 447932 0
Exploratory Endpoint: To describe serum hCG levels over time
Timepoint [2] 447932 0
Day 1 (treatment day) up until Day 9 (post-first dose).

Eligibility
Key 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
Minimum age
18 Years
Maximum age
42 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2025
Actual
Date of last participant enrolment
Anticipated
29/08/2025
Actual
Date of last data collection
Anticipated
30/09/2025
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 318853 0
Commercial sector/Industry
Name [1] 318853 0
Granata Bio Pty Ltd
Country [1] 318853 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Accelagen Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 321309 0
Commercial sector/Industry
Name [1] 321309 0
Granata Bio Pty Ltd
Address [1] 321309 0
Country [1] 321309 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317469 0
Bellberry Human Research Ethics Committee C
Ethics committee address [1] 317469 0
Ethics committee country [1] 317469 0
Australia
Date submitted for ethics approval [1] 317469 0
05/06/2025
Approval date [1] 317469 0
Ethics approval number [1] 317469 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 141142 0
Mr Ivan Lim
Address 141142 0
University of the Sunshine Coast, Building A1, SW1 Complex, 32 Cordelia Street, South Brisbane QLD 4101
Country 141142 0
Australia
Phone 141142 0
+61 7 5409 8619
Fax 141142 0
Email 141142 0
[email protected]
Contact person for public queries
Name 141143 0
Ivan Lim
Address 141143 0
University of the Sunshine Coast, Building A1, SW1 Complex, 32 Cordelia Street, South Brisbane QLD 4101
Country 141143 0
Australia
Phone 141143 0
+61 7 5409 8619
Fax 141143 0
Email 141143 0
[email protected]
Contact person for scientific queries
Name 141144 0
Ivan Lim
Address 141144 0
University of the Sunshine Coast, Building A1, SW1 Complex, 32 Cordelia Street, South Brisbane QLD 4101
Country 141144 0
Australia
Phone 141144 0
+61 7 5409 8619
Fax 141144 0
Email 141144 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.