NCT07623057 A Study Testing the Safety and Effects of FB102 in Healthy Volunteers
| NCT ID | NCT07623057 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Forte Biosciences, Inc. |
| Condition | Healthy Volunteer |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2026-06-23 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 48 participants in total. It began in 2026-06-23 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Dr. Indika P Leelasena
PRINCIPAL INVESTIGATOR
University of the sunshine coast clinical trials, Morayfield
Frequently Asked Questions
Who can join the NCT07623057 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Healthy Volunteer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07623057 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07623057 currently recruiting?
Yes, NCT07623057 is actively recruiting participants. Contact the research team at amallard@usc.edu.au for enrollment information.
Where is the NCT07623057 trial being conducted?
This trial is being conducted at Eastwood, Australia, Maroochydore, Australia.
Who is sponsoring the NCT07623057 clinical trial?
NCT07623057 is sponsored by Forte Biosciences, Inc.. The principal investigator is Dr. Indika P Leelasena at University of the sunshine coast clinical trials, Morayfield. The trial plans to enroll 48 participants.