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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат FB102 Single dose
  FB102 will be administered as a single dose
• Препарат FB102 Multiple doses
  FB102 will be administered once weekly for 4 doses.
• Препарат FB102 Placebo
  Matching placebo identical to FB102 formulation but without the active pharmaceutical ingredient

Первичные конечные точки

• Incidence, severity, and relationship to treatment of treatment-emergent adverse events (TEAEs) [Срок оценки: From day 1 to Day 85 (End of treatment visit)]
• Incidence, severity, and relationship to treatment of SAEs [Срок оценки: From day 1 to Day 85 (End of treatment visit)]

Вторичные конечные точки (4)

• Plasma PK parameters for single dose- maximum serum concentration (Cmax) [Срок оценки: Day 1,2,3,4,5,8,15,22,36,50,85]
• Plasma PK parameters for single dose- time to maximum concentration (Tmax) [Срок оценки: Day 1,2,3,4,5,8,15,22,36,50,85]
• Plasma PK parameters for Multiple dose- maximum serum concentration (Cmax) [Срок оценки: Days 1 and 22]
• Plasma PK parameters for Multiple dose- time to maximum concentration (Tmax) [Срок оценки: Days 1 and 22]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Австралия · 1 центр

• University of Sunshine Coast, Morayfield — Eastwood

Идентификаторы

NCT: NCT07623057 · FB102-102

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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