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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]

GBHMG-102

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Infertility

Condition category

Condition code

Reproductive Health and Childbirth

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]

Treatment: Drugs

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

To assess the safety and tolerability profile of daily subcutaneous administration of 225 IU GB-hMG for 7 days in healthy premenopausal women

Assessment method [1]

• Frequency and severity of all AEs, like injection site reactions, pain, inflammation. • Prior to the administration of study intervention on Day 1, the injection site should be cleaned with an antiseptic pad, prepped, and examined to assure that the areas are not inflamed, infected, swollen, painful, or otherwise abnormal. After SC administration of study intervention, the injection site will be inspected for dermal response. • Blood pressure and pulse rate will be measured after the participant has rested in sitting position for at least 3 min in a quiet setting without distractions (e.g., television, cell phones) using an automated device. Manual techniques will be used only if an automated device is not available. The acceptable systolic and diastolic blood pressure ranges are defined as between 90 and 130 mmHg, and between 50 and 80 mmHg, respectively. The acceptable pule rate range is defined as between 45 bpm and 100 bpm. Tympanic body temperature will also be assessed. If tympanic measurement is not possible, oral can also be accepted, as long as measurement is always performed the same way for the respective participant. The acceptable body temperature range is defined as between 35.5 °C and 37.7 °C. Respiratory rate will also be assessed. The acceptable respiratory rate is defined as between 12 rpm and 22 rpm. Vital signs may be repeated at the discretion of the Investigator to confirm out of range results. • A complete physical examination will be conducted at Screening and will include, at a minimum, HEENT (head, ears, eyes, nose, and throat examination), general appearance, neck (including thyroid and nodes), cardiovascular, respiratory, gastrointestinal, renal, neurological, musculoskeletal, skin and other. • A 12-lead electrocardiogram (ECG) will be performed (and the results recorded in the eCRF) to verify that the cardiac status of the participant before involvement in the study is sufficient to meet protocol entry criteria. The ECG will be performed with the participant in a supine position for 5 - 10 min, and if not tolerated, a semi-supine position. Site standard reference ranges will apply for all ECG assessments. • Blood samples should be drawn after other safety assessments (e.g., vital signs, physical examination, ECG) have been completed. The Investigator or delegate must review the laboratory results, document this review, and record any clinically significant changes occurring during the study as an AE, as determined based on the Investigator or medical delegate’s judgement.

Timepoint [1]

• 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]

To characterize the pharmacokinetic profile of GB-hMG over multiple doses.

Timepoint [2]

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]

To characterize the pharmacodynamic profile of GB-hMG over multiple doses

Timepoint [3]

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]

Exploratory Endpoint: To investigate the immunogenicity profile of GB-hMG after repeated administration in healthy premenopausal women

Timepoint [1]

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]

Exploratory Endpoint: To describe serum hCG levels over time

Timepoint [2]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Granata Bio Pty Ltd

Address [1]

Country [1]

Australia

Primary sponsor type

Commercial sector/Industry

Name

Accelagen Pty Ltd

Address

Country

Australia

Secondary sponsor category [1]

Commercial sector/Industry

Name [1]

Granata Bio Pty Ltd

Address [1]

Country [1]

Australia

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Bellberry Human Research Ethics Committee C

Ethics committee address [1]

https://bellberry.com.au/

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

05/06/2025

Approval date [1]

Ethics approval number [1]

Summary

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.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Mr Ivan Lim

Address

University of the Sunshine Coast, Building A1, SW1 Complex, 32 Cordelia Street, South Brisbane QLD 4101

Country

Australia

Phone

+61 7 5409 8619

Fax

[email protected]

Contact person for public queries

Name

Ivan Lim

Address

University of the Sunshine Coast, Building A1, SW1 Complex, 32 Cordelia Street, South Brisbane QLD 4101

Country

Australia

Phone

+61 7 5409 8619

Fax

[email protected]

Contact person for scientific queries

Name

Ivan Lim

Address

University of the Sunshine Coast, Building A1, SW1 Complex, 32 Cordelia Street, South Brisbane QLD 4101

Country

Australia

Phone

+61 7 5409 8619

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

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.

Trial Review

Documents added manually

Documents added automatically