A study testing the safety and effects of FB-102 in healthy volunteers

ISRCTN	ISRCTN10073073
DOI	https://doi.org/10.1186/ISRCTN10073073
Sponsor	Fortebioscience
Funder	Fortebioscience

Submission date: 18/05/2026
Registration date: 28/05/2026
Last edited: 28/05/2026

Recruitment status: Not yet recruiting
Overall study status: Ongoing
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Alistair Mallard
Public

19-31 Morayfield Rd, QLD
Eastwood
4556
Australia

Phone	+61 7 5409 8644
Email	amallard@usc.edu.au

Dr Indika Leelasena
Scientific, Principal investigator

19-31 Morayfield Rd, QLD
Eastwood
4556
Australia

Phone	+61 0754563965
Email	Ileelasena@usc.edu.au

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Blinded (masking used)
Control	Placebo
Assignment	Sequential
Purpose	Basic science
Scientific title	A phase 1, randomized, double-blind, placebo-controlled trial to evaluate the safety and effects after single and multiple dose administration of FB-102
Study objectives	The purpose of this Phase 1 trial is to evaluate the safety and effects of FB-102 in healthy volunteers following single and multiple doses.
Ethics approval(s)	Submitted 25/05/2026, Bellberry Human Research Ethics Committee A (Level 1, 196 Greenhill Road Eastwood Adelaide South Australia 5063, Eastwood, 5063, Australia; 0883613222; bellberry@bellberry.com.au), ref: 2026-04-572
Health condition(s) or problem(s) studied	Healthy volunteer
Intervention	Intervention Description Experimental interventions consist of FB-102 administered as either a single dose or multiple doses, compared with a placebo control. FB-102 (Investigation Product, IP) Part A (single ascending dose, SAD), participants will receive a single subcutaneous or IV dose of FB-102. Participants will be randomized in a 3:1 ratio of FB-102 or placebo. Part B (multiple ascending dose, MAD), participants will receive multiple subcutaneous doses of FB-102. Participants will be randomized in a 3:1 ratio of FB-102 or placebo. Placebo comparator: The placebo will be administered on the same schedule as the corresponding FB-102 cohort in accordance with the 3:1 randomization schema. The randomization code will be generated by our statistician, and randomization will occur manually at the site by an unblinded pharmacist who will not otherwise be involved in the study.
Intervention type	Biological/Vaccine
Phase	Phase I
Drug / device / biological / vaccine name(s)	FB-102
Primary outcome measure(s)	Incidence, severity, and relationship to treatment of treatment-emergent adverse events (TEAEs) measured using data collected from electronic Case Report Forms (eCFR) from day 1 to day 85 (end of treatment visit) at one time point
Key secondary outcome measure(s)
Completion date	17/02/2027

Eligibility

Participant type(s)
Age group	Adult
Lower age limit	18 Years
Upper age limit	60 Years
Sex	All
Target sample size at registration	56
Key inclusion criteria	1. Body mass index (BMI) between 18.0 and 32.0kg/m2, inclusive, at Screening 2. Weight ≥50 kg and ≤100kg 3. Men are required to agree to practice true abstinence; be surgically sterilized (performed at least 6 months prior and documented to no longer produce sperm - verbal confirmation through medical history review acceptable); or agree to use a condom plus effective contraception for their female partner if of childbearing potential, from Screening and for at least 90 days after the EOT visit and refrain from donating sperm during this period. Effective contraception includes established use of hormonal contraception beginning at least 4. Women are eligible to participate if they are not pregnant, not breastfeeding, and at least 1 of the following conditions apply: 4.1. Not of childbearing potential, defined as surgically sterile (hysterectomy, bilateral salpingectomy, tubal ligation or bilateral oophorectomy - verbal confirmation through medical history review is acceptable) 4.2. Postmenopausal (no menses for 12 months and confirmed by follicle-stimulating hormone[FSH] level ≥40 mlU/mL) 4.3. Of childbearing potential and agree to practice true abstinence or agree to use a highly effective method of contraception consistently from 30 days prior to the Screening visit until the EOT visit and are required to agree not to donate ova during the trial and for 90 days after the EOT visit
Key exclusion criteria	1. Any clinically significant medical condition malignancy allergy infection or immunosuppressive condition as determined by the Investigator except cured basal or squamous cell skin cancer 2. Alkaline phosphatase (ALP), aspartate transaminase (AST), alanine transaminase (ALT),and/or total bilirubin >1.5× the upper limit of normal(ULN). Participants with bilirubin >2× ULN that have a documented diagnosis of Gilbert's syndrome can be enrolled at the Investigator's discretion 3. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer considered treated and cured),treated or untreated, within 5 years before Screening, regardless of whether there is no evidence of local recurrence or metastases 4. Positive for hepatitis B surface antigen (HBsAg),anti-hepatitis C virus (HCV) antibodies, anti-human immunodeficiency virus (HIV) 1 and 2 antibodies, or interferon-gamma release assay (IGRA) for tuberculosis
Date of first enrolment	05/06/2026
Date of final enrolment	03/11/2026

Locations

Countries of recruitment

Australia

Study participating centre

University of Sunshine Coast, Morayfield

Eastwood
4556
Australia

Results and Publications

Individual participant data (IPD) Intention to share	No

Editorial Notes

28/05/2026: The dosage is not specified due to commercial sensitivity but will be added to the study record at a later date.
19/05/2026: Study’s existence confirmed by the Therapeutic Goods Administration (TGA), Australia.