A Study Testing the Safety and Effects of FB102 in Healthy Volunteers
ConditionHealthy Volunteer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorForte Biosciences, Inc.
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
Body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive, at Screening.
Weight ≥50 kg and ≤100kg.
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.
Not of childbearing potential, defined as surgically sterile (hysterectomy, bilateral salpingectomy, tubal ligation or bilateral oophorectomy - verbal confirmation through medical history review is acceptable).
Disqualifiers
Any clinically significant medical condition malignancy allergy infection or immunosuppressive condition as determined by the Investigator except cured basal or squamous cell skin cancer.
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.
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.
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.
Trial design
Design model
Sequential
Treatments tested in this trial
FB102 Single dose
DrugFB102 will be administered as a single dose
FB102 Multiple doses
DrugFB102 will be administered once weekly for 4 doses.
FB102 Placebo
DrugMatching placebo identical to FB102 formulation but without the active pharmaceutical ingredient
Treatment groups
48 Participants
are divided into 3 treatment groupsGroup A: FB102 Single doseExperimental treatment 1 intervention
Group B: FB102 Multiple doseExperimental treatment 1 intervention
Group C: FB102 PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence, severity, and relationship to treatment of treatment-emergent adverse events (TEAEs)
Time frame
From day 1 to Day 85 (End of treatment visit)2
Incidence, severity, and relationship to treatment of SAEs
Time frame
From day 1 to Day 85 (End of treatment visit)Secondary outcomes
1
Plasma PK parameters for single dose- maximum serum concentration (Cmax)
Time frame
Day 1,2,3,4,5,8,15,22,36,50,852
Plasma PK parameters for single dose- time to maximum concentration (Tmax)
Time frame
Day 1,2,3,4,5,8,15,22,36,50,853
Plasma PK parameters for Multiple dose- maximum serum concentration (Cmax)
Time frame
Days 1 and 224
Plasma PK parameters for Multiple dose- time to maximum concentration (Tmax)
Time frame
Days 1 and 22Sponsors and contacts
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Source ClinicalTrials.gov