Healthy VolunteerPhase 1NCT07623057
A Study Testing the Safety and Effects of FB102 in Healthy Volunteers
A Phase 1 study testing FB102 Single dose - Part A, FB102 Multiple doses - Part B and FB102 Multiple doses - Part C in people with Healthy Volunteer, run by Forte Biosciences, Inc. at 2 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- FB102 Single dose - Part A, FB102 Multiple doses - Part B and FB102 Multiple doses - Part C
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 2 sitesAustralia
- Study dates
- 23 Jun 2026to Jun 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia2 sites, 2 recruiting
- Recruiting
University of Sunshine Coast, Morayfield
Eastwood, Queensland, 4556
Dr Indika P Leelasena, 08 8361 3222
Dr Indika P Leelasena
- Recruiting
University of Sunshine Coast Clinical Trials, Maroochydore
Maroochydore, Queensland, 4558
Alistair Mallard, 61 7 5409 8644, amallard@usc.edu.au
About this study
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
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.
Read the detailed description
FB-102 will be administered as either a single dose (Part A) or multiple doses (Parts B and C), compared with a placebo control.
Part A (single dose), participants will receive single dose FB102 will be administered as a single dose.
Part B (multiple dose), participants will receive multiple doses of FB-102 or placebo.
Part C (multiple dose), participants will receive multiple doses of FB-102 or placebo.
Participants may participate in an Optional Extension Period during which additional blood draws for PK, PD, and immunogenicity assessments will be obtained, and AEs will continue to be monitored for approximately 15 weeks. IMP will not be administered during the Optional Extension Period.
- Conditions
- Healthy Volunteer
- Being tested
- FB102 Single dose - Part A, FB102 Multiple doses - Part B, FB102 Placebo, FB102 Multiple doses - Part C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FB102 Single dose - Part ABiological
Also called Healthy Volunteer
FB102 will be administered as a single dose
FB102 Multiple doses - Part BBiological
Also called Healthy Volunteer
FB102 will be administered once weekly for 4 doses.
FB102 PlaceboDrug
Also called Healthy Volunteer
Matching placebo identical to FB102 formulation but without the active pharmaceutical ingredient
FB102 Multiple doses - Part CBiological
FB102 will be administered once every 2 weeks for 4 doses.
| Study group | Role | What they receive |
|---|---|---|
| FB102 Single dose - Part A | Experimental | Part A (single ascending dose, SAD), FB102 will be administered as a single dose. Receives: Biological: FB102 Single dose - Part A |
| FB102 Multiple dose - Part B | Experimental | Part B (multiple ascending dose, MAD), FB102 will be administered once weekly for 4 doses. Receives: Biological: FB102 Multiple doses - Part B |
| FB102 Placebo | Placebo comparator | The placebo will be administered on the same schedule as the corresponding FB-102 cohort. Receives: Drug: FB102 Placebo |
| FB102 Multiple dose - Part C | Experimental | Part C (multiple dose), FB102 will be administered once every 2 weeks for 4 doses. Receives: Biological: FB102 Multiple doses - Part C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence, severity, and relationship to treatment of treatment-emergent adverse events (TEAEs)
Measured: From day 1 to Day 85 (End of treatment visit)
Incidence, severity, and relationship to treatment of SAEs
Measured: From day 1 to Day 85 (End of treatment visit)
Secondary outcomes (4)
Plasma PK parameters for single dose- maximum serum concentration (Cmax)
Measured: Day 1,2,3,4,5,8,15,22,36,50,85
Plasma PK parameters for single dose- time to maximum concentration (Tmax)
Measured: Day 1,2,3,4,5,8,15,22,36,50,85
Plasma PK parameters for Multiple dose- maximum serum concentration (Cmax)
Measured: Days 1 and 22
Plasma PK parameters for Multiple dose- time to maximum concentration (Tmax)
Measured: Days 1 and 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start23 Jun 2026
- Primary completionFeb 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Forte Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Indika P Leelasena, Principal investigator, University of the sunshine coast clinical trials, Morayfield
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07623057
- Sponsor's protocol ID
- FB102-102
- Status last verified
- Oct 2026
- First submitted
- 28 May 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07623057
- Acronym / sponsor ID
- FB102-102
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Forte Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Jun 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 3 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
FB-102 will be administered as either a single dose (Part A) or multiple doses (Parts B and C), compared with a placebo control.
Part A (single dose), participants will receive single dose FB102 will be administered as a single dose.
Part B (multiple dose), participants will receive multiple doses of FB-102 or placebo.
Part C (multiple dose), participants will receive multiple doses of FB-102 or placebo.
Participants may participate in an Optional Extension Period during which additional blood draws for PK, PD, and immunogenicity assessments will be obtained, and AEs will continue to be monitored for approximately 15 weeks. IMP will not be administered during the Optional Extension Period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| FB102 Single dose - Part A | Experimental | Biological: FB102 Single dose - Part APart A (single ascending dose, SAD), FB102 will be administered as a single dose. |
| FB102 Multiple dose - Part B | Experimental | Biological: FB102 Multiple doses - Part BPart B (multiple ascending dose, MAD), FB102 will be administered once weekly for 4 doses. |
| FB102 Placebo | Placebo comparator | Drug: FB102 PlaceboThe placebo will be administered on the same schedule as the corresponding FB-102 cohort. |
| FB102 Multiple dose - Part C | Experimental | Biological: FB102 Multiple doses - Part CPart C (multiple dose), FB102 will be administered once every 2 weeks for 4 doses. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FB102 Single dose - Part AAlso: Healthy VolunteerFB102 will be administered as a single dose | Biological | FB102 Single dose - Part A |
| FB102 Multiple doses - Part BAlso: Healthy VolunteerFB102 will be administered once weekly for 4 doses. | Biological | FB102 Multiple dose - Part B |
| FB102 PlaceboAlso: Healthy VolunteerMatching placebo identical to FB102 formulation but without the active pharmaceutical ingredient | Drug | FB102 Placebo |
| FB102 Multiple doses - Part CFB102 will be administered once every 2 weeks for 4 doses. | Biological | FB102 Multiple dose - Part C |
Primary outcome
Incidence, severity, and relationship to treatment of treatment-emergent adverse events (TEAEs)
Time frame: From day 1 to Day 85 (End of treatment visit)
Incidence, severity, and relationship to treatment of SAEs
Time frame: From day 1 to Day 85 (End of treatment visit)
4 secondary outcomes
Plasma PK parameters for single dose- maximum serum concentration (Cmax)
Time frame: Day 1,2,3,4,5,8,15,22,36,50,85
Plasma PK parameters for single dose- time to maximum concentration (Tmax)
Time frame: Day 1,2,3,4,5,8,15,22,36,50,85
Plasma PK parameters for Multiple dose- maximum serum concentration (Cmax)
Time frame: Days 1 and 22
Plasma PK parameters for Multiple dose- time to maximum concentration (Tmax)
Time frame: Days 1 and 22
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
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Screening Protocol
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr. Indika P Leelasena principal investigator
University of the sunshine coast clinical trials, Morayfield
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FB102 Single dose - Part A, FB102 Multiple doses - Part B and FB102 Multiple doses - Part C in people with Healthy Volunteer, run by Forte Biosciences, Inc. at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alistair Mallard (+61 7 5409 8644, amallard@usc.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence, severity, and relationship to treatment of treatment-emergent adverse events (TEAEs) (time frame: From day 1 to Day 85 (End of treatment visit)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.