A randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of FB102 after single and multiple ascending dose administrations in healthy participants
Forte Biosciences Australia Pty Ltd
80 participants
Dec 6, 2023
Interventional
Conditions
Summary
This is a first-in-human, single-centre, randomised, double blind, two-part single and multiple ascending dose study to assess the safety of FB102-101, and how this drug acts in the body in healthy volunteers. FB102-101 may be indicated for use in patients with autoimmune and inflammatory diseases, but a trial of the drug in healthy volunteers is needed before trials in patients with autoimmune and inflammatory diseases can proceed. Who is it for? You may be eligible for this study if you are aged 18 to 60 years and are in good general health without a clinically significant medical history. Study details: All healthy volunteer participants who choose to enrol in this study will be assigned by chance to receive either a single or multiple doses of FB102 or placebo. All participants will have their vital signs checked (heart rate, blood pressure, temperature, etc), and will provide blood and urine samples for testing. The data generated in this study will inform the design of future clinical studies and to select the dose(s) for future studies in patients with autoimmune and inflammatory diseases.
Eligibility
Inclusion Criteria5
- Men and women ages 18 to 60 years old, inclusive, at screening.
- Body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive, at screening.
- Weight greater than or equal to 50 kg and less than or equal to 100kg for men and greater than or equal to 45 kg and less than or equal to 95kg for women.
- Good physical and mental health on the basis of medical history, physical examination, clinical laboratory, ECG, and vital signs, as judged by the Investigator.
- Willing and able to understand and sign the participant informed consent form (PICF).
Exclusion Criteria2
- History of any clinically significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, metabolic, psychological, musculoskeletal disease or malignancies, significant allergies (except for untreated, asymptomatic seasonal allergies at the time of dosing), immunosuppressive conditions or medications, recent or recurrent infections, or any other clinically significant disease, as assessed by the Investigator. Basal cell or squamous cell carcinoma of the skin that has been fully excised and is considered cured is acceptable.
- Any other medical condition or social circumstance, which in the opinion of the Investigator, would impede compliance with or hinder completion of the study.
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Interventions
This is a randomized, double-blind, placebo-controlled study of FB102 in healthy participants. Part A is the single ascending dose (SAD) portion, and Part B is the multiple ascending dose (MAD) portion. Part A: (SAD) Up to 6 groups (Groups A1 to A6) of 8 healthy participants per group. Group A1: 3 mg/kg Intravenous (IV) dose Group A2: 7.5 mg/kg IV dose Group A3: 15 mg/kg IV dose Group A4: 1 mg/kg Subcutaneous (SC) dose Group A5: 3 mg/kg SC dose Group A6: IV or SC dose (TBD) of FB102* * The SMC will determine the dose for Group A6 based on cumulative review of safety and PK data from prior groups. The dose will not exceed 15 mg/kg. Part B: (MAD) Up to 4 groups (Groups B1 to B4) of 8 healthy participants. Within each group, participants will receive 4 weekly doses Group B1: 3 mg/kg IV doses Group B2: 10 mg/kg IV doses Group B3: 15 mg/kg IV doses Group B4: multiple lV or SC doses (TBD)# #The SMC will determine the dose and route (IV or SC) for Group B4 based on cumulative review of safety and PK data from prior groups. The dose will not exceed 15 mg/kg. Adherence to Intervention will be managed via recording in appropriate drug accountability records.
Locations(1)
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ACTRN12623001199606