FB102 Single doseFB102 Multiple dosesFB102 Placebo
FB102 Single dose: FB102 will be administered as a single dose
FB102 Multiple doses: FB102 will be administered once weekly for 4 doses.
FB102 Placebo: Matching placebo identical to FB102 formulation but without the active pharmaceutical ingredient
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
Accepted
Inclusion Criteria:
1. Body mass index (BMI) between 18.0 and 32.0 kg/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 30 days prior to the Screening visit; or placement of an intrauterine device or intrauterine system. These contraception requirements do not apply if the male participant is in an exclusively same sex relationship; sperm donation prohibitions apply.
4. Women are eligible to participate if they are not pregnant, not breastfeeding, and at least 1 of the following conditions apply:
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).
2. Postmenopausal (no menses for 12 months and confirmed by follicle-stimulating hormone \[FSH\] level ≥40 mlU/mL).
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.
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.
Primary outcome measure(s)
Incidence, severity, and relationship to treatment of treatment-emergent adverse events (TEAEs) — From day 1 to Day 85 (End of treatment visit)
Incidence, severity, and relationship to treatment of SAEs — From day 1 to Day 85 (End of treatment visit)
Trial sites (2)
Facility
City
Region
Status
University of Sunshine Coast, Morayfield
Eastwood
Queensland
Recruiting
University of Sunshine Coast Clinical Trials, Maroochydore
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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