A Phase 1 Study of the Safety and Tolerability of Single and Multiple Doses of ANK-700 in Patients With Relapsing Remitting Multiple Sclerosis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Anokion SA
- 入组人数
- 34
- 试验地点
- 15
- 主要终点
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)
研究概览
简要总结
A safety study of ANK-700 in patients with relapsing remitting multiple sclerosis. The study has two parts:
Part A - first in human study in which patients receive a single dose of ANK-700 Part B - patients will receive three doses of either ANK-700 or placebo
详细描述
Study ANK-700-01 is a Phase 1, FIH study designed to evaluate the safety and tolerability of ANK-700 in patients with relapsing remitting multiple sclerosis (rrms).
An overview of the two parts and proposed dose groups is given below:
Part A (SAD): Patients will receive a single dose of ANK-700. Part B (MAD): Patients will receive three doses of either ANK-700 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
- Double (Participant, 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
- 否
入选标准
- •Diagnosed with RRMS per revised McDonald criteria (2017) with an EDSS score ≤ 6.5 at screening
- •Neurologically stable with no evidence of relapse within the 28 days before signing the informed consent form (ICF)
- •Either not currently receiving disease modifying MS therapy, or currently using fumarate drugs (dimethyl fumarate or diroximel fumarate)
- •Patients must use a highly effective method of birth control or are sterile or postmenopausal as confirmed by study Investigator
- •Patient has signed and understands the ICF
排除标准
- •Diagnosis of primary progressive MS or secondary progressive MS
- •Uncontrolled or significant medical conditions (including active infection or chronic hepatitis) which, in the opinion of the Investigator, preclude participation
- •Patients treated with glatiramer acetate, parenteral steroids or adrenocorticotropic hormone, β-interferon, plasma exchange within the 3 months prior to first dose
- •Patients treated with sphingosine-1-phospate receptor modulators such as fingolimod, ozanimod, or siponimod within 6 months prior to first dose
- •Patients treated with cytotoxic agents (including, but not limited to, cladribine, mitoxantrone, cyclophosphamide, azathioprine, and methotrexate), laquinimod, teriflunomide, or IV gamma globulin within 12 months prior to first dose
- •Patients treated with monoclonal antibody therapy (including natalizumab, daclizumab, rituximab, ofatumumab, and ocrelizumab) within 24 months prior to first dose
- •Patients previously treated with alemtuzumab, total lymphoid irradiation, mesenchymal stem cell or hematopoietic stem cell transplantation, or tolerance-inducing therapies for MS
- •Contraindication to or inability to undergo gadolinium-enhanced magnetic resonance imaging (MRI) scan
- •Use of any investigational drug or experimental procedure within previous 6 months that would interfere with the assessment of ANK-700
- •Patients who are pregnant or breastfeeding
- •Patients receiving any vaccination within 28 days prior to first dose
- •Patient does not agree to limit alcohol intake to 2 drink equivalents or less per day during the study
研究组 & 干预措施
ANK-700 SAD Cohort 1, 0.3 mg/kg ANK-700
All enrolled patients will receive one dose of 0.3 mg/kg ANK-700
干预措施: ANK-700 (Drug)
ANK-700 SAD Cohort 2, 1.0 mg/kg ANK-700
All enrolled patients will receive one dose of 1.0 mg/kg ANK-700
干预措施: ANK-700 (Drug)
ANK-700 SAD Cohort 3, 3.0 mg/kg ANK-700
All enrolled patients will receive one dose of 3.0 mg/kg ANK-700
干预措施: ANK-700 (Drug)
MAD Cohort 4 0.3 mg/kg ANK-700 or Placebo
All enrolled patients will receive three doses of 0.3 mg/kg ANK-700 or placebo
干预措施: ANK-700 (Drug)
MAD Cohort 4 0.3 mg/kg ANK-700 or Placebo
All enrolled patients will receive three doses of 0.3 mg/kg ANK-700 or placebo
干预措施: Placebo (Drug)
MAD Cohort 5 1.0 mg/kg ANK-700 or placebo
All enrolled patients will receive three doses of 1.0 mg/kg ANK-700 or placebo
干预措施: ANK-700 (Drug)
MAD Cohort 5 1.0 mg/kg ANK-700 or placebo
All enrolled patients will receive three doses of 1.0 mg/kg ANK-700 or placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
时间窗: Up to 1 year
Incidence and severity of treatment-emergent adverse events (TEAEs) as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 or higher
次要结局
- CMAX(Days 1 and 7: One PK sample was taken pre-dose (≥at least 5 min prior to infusion), with all subsequent PK samples taken after end of infusion at the following time points: 0 min, 7min, 15min, 30min, 1h, 2h, 3h, 4h, 6h, 8h)
- AUC Last(Days 1 and 7: One PK sample was taken pre-dose (≥at least 5 min prior to infusion), with all subsequent PK samples taken after the end-of-infusion at the following time points: 0 min, 7 min, 15min, 30 min, 1h, 2h, 3h, 4h, 6h, 8h)