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

A Phase 1, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity After Single and Multiple Dose Administration of FB102 Administered in Healthy Participants

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: FB102 Single dose; Drug: FB102 Multiple doses; Drug: FB102 Placebo

Detailed Description

FB-102 will be administered as either a single dose (Part A) or multiple doses (Part B), compared with a placebo control.

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

Part B (multiple ascending dose, MAD), participants will receive multiple doses of FB-102 or placebo.

• Study Type: Interventional
• Enrollment (Estimated): 56
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Alistair Mallard; Phone Number: +61 7 5409 8644; Email: amallard@usc.edu.au

Study Locations

• Australia
  • Queensland
    • Eastwood, Queensland, Australia, 4556
      • University of Sunshine Coast, Morayfield
      • Contact: Dr Indika P Leelasena; Phone Number: 08 8361 3222
      • Principal Investigator: Dr Indika P Leelasena

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FB102 Single dose; Part A (single ascending dose, SAD), FB102 will be administered as a single dose.	Drug: FB102 Single dose; FB102 will be administered as a single dose; Other Names: Healthy Volunteer
Experimental: FB102 Multiple dose; Part B (multiple ascending dose, MAD), FB102 will be administered once weekly for 4 doses.	Drug: FB102 Multiple doses; FB102 will be administered once weekly for 4 doses.; Other Names: Healthy Volunteer
Placebo Comparator: FB102 Placebo; The placebo will be administered on the same schedule as the corresponding FB-102 cohort.	Drug: FB102 Placebo; Matching placebo identical to FB102 formulation but without the active pharmaceutical ingredient; Other Names: Healthy Volunteer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Forte Biosciences, Inc.
• Investigators: Principal Investigator: Dr. Indika P Leelasena, University of the sunshine coast clinical trials, Morayfield

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: May 28, 2026
• First Submitted That Met QC Criteria: May 28, 2026
• First Posted (Actual): June 3, 2026

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: FB102-102

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No