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

NCT07623057 | Not Yet Recruiting Phase 1

• 1 other identifier: FB102-102
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (4)

• Plasma PK parameters for single dose- maximum serum concentration (Cmax)

  Day 1,2,3,4,5,8,15,22,36,50,85

• Plasma PK parameters for single dose- time to maximum concentration (Tmax)

  Day 1,2,3,4,5,8,15,22,36,50,85

• Plasma PK parameters for Multiple dose- maximum serum concentration (Cmax)

  Days 1 and 22

• Plasma PK parameters for Multiple dose- time to maximum concentration (Tmax)

  Days 1 and 22

Study Arms (3)

FB102 Single dose

EXPERIMENTAL

Part A (single ascending dose, SAD), FB102 will be administered as a single dose.

Drug: FB102 Single dose

FB102 Multiple dose

EXPERIMENTAL

Part B (multiple ascending dose, MAD), FB102 will be administered once weekly for 4 doses.

Drug: FB102 Multiple doses

FB102 Placebo

PLACEBO COMPARATOR

The placebo will be administered on the same schedule as the corresponding FB-102 cohort.

Drug: FB102 Placebo

Interventions

FB102 Single dose DRUG

FB102 will be administered as a single dose

Also known as: Healthy Volunteer

FB102 Single dose

FB102 Multiple doses DRUG

FB102 will be administered once weekly for 4 doses.

Also known as: Healthy Volunteer

FB102 Multiple dose

FB102 Placebo DRUG

Matching placebo identical to FB102 formulation but without the active pharmaceutical ingredient

Also known as: Healthy Volunteer

FB102 Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Women are eligible to participate if they are not pregnant, not breastfeeding, and at least 1 of the following conditions 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).
• Postmenopausal (no menses for 12 months and confirmed by follicle-stimulating hormone \[FSH\] level ≥40 mlU/mL).
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Forte Biosciences, Inc.: lead

Study Sites (1)

University of Sunshine Coast, Morayfield

Eastwood, Queensland, 4556, Australia

Location

Study Officials

• Dr. Indika P Leelasena

  University of the sunshine coast clinical trials, Morayfield

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alistair Mallard

CONTACT

+61 7 5409 8644; amallard@usc.edu.au

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2026
• First Posted: June 3, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: June 3, 2026

Record last verified: 2026-05

Locations

AU (1)