Testing FB102 safety and effects in healthy adults
Official title: 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 Subcutaneously or Intravenously in Healthy Participants
Run by Forte Biosciences, Inc. · NCT07623057 · Data updated 2026-11-12
This early-phase study tests whether a single or multiple doses of FB102 are safe and what effects they have in healthy adults.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 64 (estimated) |
| Sponsor | Forte Biosciences, Inc. Industry-sponsored |
| Locations | 2 sites (Eastwood, Queensland and 1 other locations) |
| Status | Recruiting |
| Started | June 23, 2026 |
| Main results expected | February 2027 |
| Study ends | June 2027 |
| Registry record updated | October 21, 2026 |
| Trial ID | NCT07623057 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy adults aged eligible BMI 18.0–32.0 kg/m2, weight 50–100 kg, and who meet contraception and non-pregnancy criteria.
✕Probably not a fit
Participants who do not respond to or tolerate FB102, or who are not expected to gain any direct health benefit from the study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 1 interventional trial evaluating FB102 in healthy volunteers. Participants receive a single dose (Part A) or multiple doses (Parts B and C), each compared to placebo. An optional extension period may extend monitoring for pharmacokinetics, pharmacodynamics, and safety for about 15 weeks after the last dose. The study includes safety assessments and blood draws, with dosing and follow-up conducted at study sites in Queensland, Australia.
Why it matters
Potential benefit: If successful, FB102 could advance understanding of its safety profile and pharmacology in humans, potentially informing future therapeutic development.
How similar studies have gone: Phase 1 studies of similar agents have shown acceptable safety and PK/PD profiles in healthy volunteers; this design follows established first-in-human approaches.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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University of Sunshine Coast, Morayfield
Eastwood, Queensland, Australia Recruiting -
University of Sunshine Coast Clinical Trials, Maroochydore
Maroochydore, Queensland, Australia Recruiting
Study contacts
- Principal investigator: Dr. Indika P Leelasena — University of the sunshine coast clinical trials, Morayfield
- Study coordinator: Alistair Mallard
- Email: amallard@usc.edu.au
- Phone: +61 7 5409 8644
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.