NCT07623057招募中1 期
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
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 3
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
FB102 Single dose
Experimental
Part A (single ascending dose, SAD), FB102 will be administered as a single dose.
干预措施: FB102 Single dose (Drug)
FB102 Multiple dose
Experimental
Part B (multiple ascending dose, MAD), FB102 will be administered once weekly for 4 doses.
干预措施: FB102 Multiple doses (Drug)
FB102 Placebo
Placebo Comparator
The placebo will be administered on the same schedule as the corresponding FB-102 cohort.
干预措施: FB102 Placebo (Drug)
研究者
研究点 (3)
Loading locations...
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