Health Trials

A Study Testing the Safety and Effects of FB102 in Healthy Volunteers

ConditionHealthy Volunteer
Trial statusNot yet recruiting
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

Qualifiers

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

Treatments tested in this trial

  • FB102 Single dose
  • FB102 Multiple doses
  • FB102 Placebo

Treatment groups

56 Participants
are divided into 3 treatment groups

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

University of Sunshine Coast, Morayfield Status unavailable 4556, Eastwood, QueenslandAustraliaAustralia

Sponsors and collaborators

Forte Biosciences, Inc.

Lead sponsor

Source ClinicalTrials.gov