Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625001024437p
Ethics application status
Submitted, not yet approved
Date submitted
13/08/2025
Date registered
16/09/2025
Date last updated
16/09/2025
Date data sharing statement initially provided
16/09/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
A Study Testing the Safety and Tolerability of Different Single and Repeated Doses of the Oral Drug FT2109, With and Without Food in Healthy Adults
Scientific title
A Randomized, Double-blind, Placebo-controlled, First-in-human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Ascending Single and Multiple Oral Doses of FT2109, Including the Effect of Food, in Healthy Adults
Secondary ID [1] 315096 0
FT2109-1001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammatory diseases 338493 0
Condition category
Condition code
Inflammatory and Immune System 334798 334798 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1 PART A: Single Ascending Dose (SAD)
Drug Name: FT2109
Dose: 2 mg, 6 mg, 15 mg, 30 mg, 60 mg, or 100 mg (nominal dose levels; actual doses determined by Safety Review Committee)
Duration: Single dose
Mode of Administration: Oral capsule
Special Conditions: One cohort (nominally 30 mg) includes food effect evaluation (participants dosed under fed and fasted conditions). Participants will be randomised to drug and placebo.

Details of fed/fasted conditions:
Fasted state: Participants fasted for 10 hours prior to dosing and for 4 hours post-dose on Period 1, Day 1 (single dose). On Period 2, Day 8, participants fasted for at least 8 hours before consuming the meal.
Fed state meal: A standard high-fat, high-calorie breakfast comprising: Two eggs fried in butter, Two rashers of bacon,Two slices of toast with 16 g butter per slice, 125 g of hash browns, 125 mL of full cream milk
Timing of dosing relative to meal: On Period 2, Day 8, participants commence the meal 30 minutes prior to dosing and are required to consume it within 30 minutes. A single dose of FT2109 or placebo is administered immediately after meal completion.

Arm 2 PART B : Multiple Ascending Dose (MAD)
Drug Name: FT2109
Dose: Final doses determined based on PK/safety data from Part A; not to exceed highest SAD dose
Dosing Schedule: Once daily (QD) or twice daily (BID) for 10 days
Mode of Administration: Oral capsule

Adherence to intervention will be assessed through IP accountability performed at site and reviewed by the study CRA.
Intervention code [1] 331710 0
Treatment: Drugs
Comparator / control treatment
Matching Placebo capsules made of hypromellose (hydroxypropyl methyl cellulose or HPMC)
Control group
Placebo

Outcomes
Primary outcome [1] 342436 0
PART A To evaluate the safety and tolerability of FT2109 following single ascending doses in healthy participants. Safety and tolerability will be assessed as a composite primary outcome.
Timepoint [1] 342436 0
PART A -Adverse event monitoring will be conducted daily from Screening Day -35 through Day 8 +/- 1 day (final study visit), and on dosing day at pre-dose and at 0, 2, 4, and 8 hours post-dose. -Safety laboratory blood and Urinalysis samples will be collected during Screening (Day -35 to -8), Baseline (Day -1), and on Days 2, 5, and Day 8 +/- 1 day (final study visit) -Vital signs (BP, HR, temperature, respiratory rate, oxygen saturation) conducted daily from Screening Day -35 through Day 8 +/- 1 day (final study visit), and on dosing day at pre-dose and at 0, 2, 4, and 8 hours post-dose. -Twelve-lead ECGs conducted daily from Screening Day -35 through Day 8 +/- 1 day (final study visit), and on dosing day at pre-dose and at 0, 2, 4, and 8 hours post-dose. Telemetry will be performed multiple timepoints on Day 1
Primary outcome [2] 342437 0
PART B To evaluate the safety and tolerability of FT2109 following multiple ascending doses in healthy participants. Safety and tolerability will be assessed as a composite primary outcome.
Timepoint [2] 342437 0
PART B -Adverse event monitoring will be conducted daily from Screening Day -35 through Day 8 +/- 1 day (final study visit), and on dosing day at pre-dose and at 0, 2, 4, and 8 hours post-dose. -Safety laboratory blood and Urinalysis samples will be collected during Screening (Day -35 to -8), Baseline (Day -1), and on Days 2, 5, and Day 8 +/- 1 day (final study visit) -Vital signs (BP, HR, temperature, respiratory rate, oxygen saturation) conducted daily from Screening Day -35 through Day 17 +/- 1 day (final study visit) -Twelve-lead ECGs conducted at Screening (Day -35 to Day-8) Day 1 at multiple time points, Day 5 at multiple time points, Day 10 at multiple time points, Day 11, day 12, Day 14 and Day 17 +/- 1 day (final study visit), Telemetry will be performed on Day 1,2,4,5,6,7,8,10,11 -Physical examinations will be performed on Screening (Day -35 to Day-8) and Day 17 +/- 1 day (final study visit) - Concomitant medication reviews will be preformed daily on Screening (Day -35 to Day-8) through to Day 17 +/- 1 day (final study visit)
Secondary outcome [1] 450815 0
PART A To assess the pharmacokinetic (PK) parameters of FT2109 following single ascending doses in healthy participants 
Timepoint [1] 450815 0
PART A Blood plasma samples will be assessed pre-dose Day 1, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hrs post-dose, Day 2 24 hrs post-dose, Day 3 48 hrs post-dose, Day 5 post-dose and Day 8 End of Study/Early Termination (EOS/ET).
Secondary outcome [2] 450816 0
PART A To evaluate the effect of a high-fat, high-calorie meal in healthy participants on the PK parameters of FT2109 (Cohort A4 only)
Timepoint [2] 450816 0
PART A Period 1 Fasted - Blood plasma samples will be assessed pre-dose Day 1, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hrs post-dose, Day 2 24 hrs post-dose, Day 3 48 hrs post-dose, Day 5 and Day 6 post-dose. Period 2 Fed - Blood plasma samples will be assessed pre-dose Day 8, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hrs post-dose, Day 9 24 hrs post-dose, Day 10 48 hrs post-dose, Day 12 post-dose and Day 15 +/- 1 day End of Study/Early Termination (EOS/ET).
Secondary outcome [3] 450817 0
PART B To assess the pharmacokinetic (PK) parameters of FT2109 following multiple ascending doses in healthy participants
Timepoint [3] 450817 0
PART B Blood plasma samples will be assessed pre-dose Day 1, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hrs post-dose, pre-dose on Days 2, 3, 4, 6, 7, 8 and Day 9, pre-dose day 10, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hrs post-dose, Day 11 24 hrs post-dose, Day 12 48 hrs post-dose, Day 14 and Day 6 post-dose and Day 17 +/- 1 dayEnd of Study/Early Termination (EOS/ET). - Additional pre-dose trough levels may be collected on Days 2–9 to assess steady-state accumulation (if included in the sampling schedule)

Eligibility
Key inclusion criteria
1. Must have given written informed consent before any study-related activities are performed and must be able to understand the full nature and purpose of the study, including possible risks and adverse effects.
2. Adult males and females, 18 to 55 years of age (inclusive) at screening.
3. Body mass index (BMI) = 18.0 to 32.0 kg/m2, and with body weight equal to, or greater that 50.0 kg (males) and 45 kg (females)at screening.
4. Medically healthy (in the opinion of the PI or delegate), as determined by pre-study medical history, and without clinically significant (CS) abnormalities including the following:
a. Physical examination without any clinically relevant findings;
b. Systolic blood pressure in the range of 90 to 150 mmHg and diastolic blood pressure in the range of 40 to 90 mmHg after resting for 5 minutes in a supine or semi-supine position.
c. Pulse rate in the range of 40 to 100 bpm after 5 minutes resting in a supine or semi-supine position.
d. Body temperature (tympanic), between 35.5°C and 37.7°C.
e. Electrocardiogram without CS abnormalities including QT interval corrected using the Fridericia formula (QTcF) <450 msec for males and <470 msec for females.
f. No CS findings in clinical chemistry, hematology, coagulation, and urinalysis tests.
5. Female volunteers:
a. Must be of non-child-bearing potential i.e., surgically sterilized (hysterectomy, bilateral salpingectomy, bilateral oophorectomy) at least 6 weeks before the screening visit or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause and a follicle-stimulating hormone [FSH] level consistent with postmenopausal status, per local laboratory guidelines), or
b.If of child-bearing potential, must:
i. Have a negative pregnancy test at the screening visit and on admission to the study site on Day-1.
ii. Agree not to attempt to become pregnant or donate ova from signing the ICF until at least 37 days after the last dose of study drug.
iii. Agree to use adequate contraception (defined as use of a condom by the male partner combined with use of a highly effective method of contraception from one month prior to screening until at least 37 days after the last dose of study drug, if not exclusively in a same-sex relationship or abstinent as a committed lifestyle.
6. Male volunteers:
a. Must agree not to donate sperm from signing the ICF until at least 97 days after the last dose of study drug.
b. If engaging in sexual intercourse with a female partner who could become pregnant, must agree to use adequate contraception (defined as use of a condom combined with use of a highly effective method of contraception from signing the ICF until at least 97 days after the last dose of study drug.
c. If engaging in sexual intercourse with a female partner who is not of childbearing potential or a same-sex partner, must agree to use a condom from signing the ICF until at least 97 days after the last dose of study drug.
7. Have suitable venous access for blood sampling.
8. Willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Known hypersensitivity to the study drug or any of the study drug ingredients.
2. History of anaphylaxis or other significant allergy which, in the opinion of the PI (or delegate), would interfere with the volunteer’s ability to participate in the study.
3. History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, psychiatric, or neurological disease/disorder, including any acute illness, within the past 3 months determined by the PI (or delegate) to be clinically relevant.
4. Previous exposure to any TNF inhibitors or antagonists within 3 months prior to study drug administration.
5. History of surgery or hospitalization within 3 months prior to screening, or surgery planned during the study.
6. Any history of malignant disease in the last 10 years (excludes surgically resected skin squamous cell or basal cell carcinoma).
7. Presence of clinically relevant immunosuppression from, but not limited to, immunodeficiency conditions such as common variable hypogammaglobulinemia.
8. History of risk factors for torsade de pointes (including a family history of long QT syndrome or sudden cardiac death) or a known arrythmia.
9. Presence or having sequelae of gastrointestinal, liver (including Gilbert’s syndrome), kidney, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
10. Liver function test results elevated more than 1.5x the ULN for gamma glutamyl transferase, bilirubin (total, conjugated and unconjugated), ALP, AST or ALT.
11. Estimated glomerular filtration rate is equal to or less than or equal to 80 mL/min/1.73m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation (2021).
12. A history of or positive test results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies at the screening visit.
13. Positive drugs of abuse test, carbon monoxide breath test or alcohol breath test results at the screening visit and/or on admission to the study site on Day 1.
14. Regular consumption of more than 10 standard alcoholic drinks/week and/or more than 4 standard alcoholic drinks on any one day, where 1 standard drink is 10 g of pure alcohol and is equivalent to 285 mL beer [4.9% Alc/Vol], 100 mL wine [12% Alc/Vol], or 30 mL spirit [40% Alc/Vol]).
15. Any use of tobacco containing products and nicotine or nicotine containing products for three months prior to Day -1, and/or the volunteer is unwilling to abstain from smoking or the use of nicotine-containing products for 3 months prior to check-in on Day -1 and throughout the confinement period at the study site and until EoS (non-smokers preferred).
16. Females who are breastfeeding or planning to breastfeed.
17. Unable to swallow oral medication
18. Use of any prescription or over-the-counter medication (including herbal products, diet aids, vitamins, and hormone supplements) within 7 days (or 14 days if the drug is a potential CYP3A4/5 enzyme inducer or inhibitor) or 5 half-lives of the medication (whichever is longer) prior to the first dose of study drug. With the exception of the use of ibuprofen (up to 1200 mg per day) or paracetamol (up to 2 g per day) for no more than 3 consecutive days.
19. Consumption of poppy seeds or other products containing poppy seeds within 2 days prior to screening and 2 days prior to check-in on Day -1, consumption of citrus fruits (e.g., Seville orange, grapefruit and similar) or their juices 7 days prior to study drug administration until EoS. Excessive consumption (more than 3 cups per day) of caffeine and/or xanthene products (eg, coffee, tea, chocolate, and caffeine-containing sodas, colas) per day and will abstain from ingesting from 24 hours prior to study drug administration until EoS.
20. Current infection that requires systemically absorbed antibiotic, antifungal, antiparasitic or antiviral medication within 10 days prior to first dose of study drug.
21. History of opportunistic infection(s)(such as: herpes zoster, mycoplasma, Pneumocystis carinii, histoplasma, Aspergillus, mycobacterium) within 6 months prior to screening;
22. Known recurrent or chronic infectious disease(s) history, including but not limited to: chronic kidney infect, chronic chest infection(such as bronchiectasis), nasosinusitis, recurrent urinary tract infection, open, drainage or infected wounds of the skin;
23. Tuberculosis(TB) history, or suspected clinically TB (including but not limited to: pulmonary tuberculosis, lymphoid tuberculosis, tuberculous pleurisy), or a positive Tuberculosis spot test;
24. Use of live (attenuated) vaccinations within 3 months and/or non-live vaccines within 1 month prior to Day -1 or plans to receive these vaccines at any time throughout the trial or 2 weeks after EoS.
25. Donation of blood or plasma within 30 days prior to first dose of study drug, or loss of whole blood of more than 500 mL within 30 days prior to first dose of study drug, or receipt of a blood transfusion within 1 year of the first dose of study drug.
26. Participation in another clinical study of an investigational drug or investigational device within 30 days or 5 half-lives of the investigational drug (whichever is longer) prior to screening.
27. Any other condition or prior therapy that in the opinion of the PI (or delegate) would make the volunteer unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likelihood of noncompliance with any study requirements.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed using a centralized randomization process. The randomization schedule will be generated and maintained by unblinded statisticians at the Contract Research Organization (CRO) and stored under controlled access conditions to prevent unauthorized disclosure.
Allocation details will not be accessible to site staff involved in participant enrollment or clinical assessments. To maintain concealment until the point of assignment, sealed, participant-specific code break envelopes will be prepared in advance and securely stored at site. These envelopes will only be accessed in the event of a medical emergency.
Study drug allocation will be managed by unblinded pharmacy staff, who will dispense treatment based solely on randomization numbers provided , without revealing the assigned intervention to blinded study personal
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation to FT2109 or placebo/comparator will be performed using a block randomization algorithm and will be documented in the study randomization schedule. Randomization numbers assigned will be in accordance with this randomization schedule.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

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
13/10/2025
Actual
Date of last participant enrolment
Anticipated
30/03/2026
Actual
Date of last data collection
Anticipated
30/04/2026
Actual
Sample size
Target
72
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 28306 0
Scientia Clinical Research - Randwick
Recruitment postcode(s) [1] 44518 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 319667 0
Commercial sector/Industry
Name [1] 319667 0
Forward Therapeutics, Pty Ltd
Country [1] 319667 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Forward Therapeutics, Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 322170 0
Commercial sector/Industry
Name [1] 322170 0
Avance Clinical Pty Ltd
Address [1] 322170 0
Country [1] 322170 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 318231 0
Bellberry Human Research Ethics Committee A
Ethics committee address [1] 318231 0
Ethics committee country [1] 318231 0
Australia
Date submitted for ethics approval [1] 318231 0
20/08/2025
Approval date [1] 318231 0
Ethics approval number [1] 318231 0

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

Contacts
Principal investigator
Name 143514 0
Dr Christopher Argent
Address 143514 0
Scientia Clinical Research Level 5 and 6, The Bright Building, Corner of High and Avoca St, Randwick NSW 2031, Australia
Country 143514 0
Australia
Phone 143514 0
+61 433 182 115
Fax 143514 0
Email 143514 0
[email protected]
Contact person for public queries
Name 143515 0
Christopher Argent
Address 143515 0
Scientia Clinical Research Level 5 and 6, The Bright Building, Corner of High and Avoca St, Randwick NSW 2031, Australia
Country 143515 0
Australia
Phone 143515 0
+61 433 182 115
Fax 143515 0
Email 143515 0
[email protected]
Contact person for scientific queries
Name 143516 0
Christopher Argent
Address 143516 0
Scientia Clinical Research Level 5 and 6, The Bright Building, Corner of High and Avoca St, Randwick NSW 2031, Australia
Country 143516 0
Australia
Phone 143516 0
+61 433 182 115
Fax 143516 0
Email 143516 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.