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A Phase 1/2a Study of Oral PRO-1562 in Healthy Subjects and Patients With Relapsing Multiple Sclerosis

2026年9月11日 更新者：Progentos Therapeutics

A Randomized, Double-Blind, Placebo-Controlled Phase 1/2a Trial of PRO-1562 in Healthy Adults and Adults With Multiple Sclerosis and Chronic Optic Neuropathy

Phase 1 will test single oral doses of PRO-1562 in healthy adult subjects to characterize the safety and the amount of drug that is absorbed into the body. Some subjects will have lumbar punctures performed to measure the amount of drug that crosses the blood-brain barrier since that is the site of drug activity.

Phase 2a will be a 6-month trial to test the ability of once monthly dosing of PRO-1562 to promote remyelination of the CNS and provide clinical benefit to adult patients with relapsing multiple sclerosis (RMS) who also have long-term vision problems diagnosed as chronic optic neuropathy. The benefits of remyelination will be measured using tests of visual acuity, speed of optic nerve conduction signals, and clinical assessments of cognitive and motor function. PRO-1562 will be added on to a stable regimen of MS disease modifying therapy.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

Phase 1 is a randomized, double-blind, placebo-controlled, single-ascending dose (SAD) trial of PRO-1562 in healthy adult participants at a single clinical research unit to characterize the safety and pharmacokinetics of a range of oral doses of PRO-1562. Phase 2a is a randomized, double-blind, placebo-controlled, multi-center, 6-month trial of PRO-1562 in adult patients with relapsing multiple sclerosis who also have chronic optic neuropathy. Patients will remain on their stable regimen of an approved MS disease modifying therapy during the trial. Oral PRO-1562 or placebo will be dosed once a month at scheduled clinic visits. Participants will be given the option to continue on their assigned study treatment after completing the 6-month treatment period until the last patient completes the 6-month treatment period.

研究类型

介入性

注册 (估计的)

160

阶段

  • 阶段2
  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 澳大利亚
    • South Australia
      • Adelaide、South Australia、澳大利亚、5000
        • CMAX Clinical Research
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

描述

Phase 1 Inclusion Criteria:

  1. Able and willing to provide written informed consent
  2. Body weight ≥ 48 kg (105.6 lbs) and body mass index (BMI) ≥ 18.5 and ≤ 30 kg/m2
  3. Must be in good health and without clinically significant abnormalities by review of medical and surgical history, physical examination, vital signs measurement, and 12-lead ECG
  4. No clinically-significant laboratory abnormalities
  5. Willing and able to use highly-effective forms of contraception for at least 30 days after the end of study visit.

Phase 1 Exclusion Criteria:

  1. Ongoing medical condition requiring systemic therapy.
  2. Ongoing infection
  3. mRNA or live vaccine during the past 60 days
  4. History of significant hypersensitivity, intolerance, or allergy to any drug/medication
  5. Participation in another clinical trial with an investigational agent within 30 days prior to Check-in or 5 half-lives (if known) of the investigational drug's PK, PD, or biological activity (if known), whichever is longer
  6. Positive alcohol breath test or urine screen for drugs of abuse.
  7. Use or intent to use natural products or nutritional/dietary supplements (including St. John's wort), vitamins, minerals, and phytotherapeutic /herbal/plant-derived preparations within or received within 14 days or 5 half-lives prior to Check-in, whichever is longer.
  8. Poor peripheral venous access.
  9. Receipt of blood products within 2 months prior to Check-in.
  10. Donation of blood or blood products during the 4 weeks prior to Check-in.
  11. Participants who in the opinion of the Principal Investigator (or designee), should not participate in this study

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：单组作业
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：Phase 1, PRO-1562 Dose level 1
PRO-1562 oral capsule
药品：PRO-1562 Oral Capsules
Oral, CNS-penetrant small molecule designed to induce remyelination
实验性的：Phase 1, PRO-1562 Dose level 2
PRO-1562 oral capsule
药品：PRO-1562 Oral Capsules
Oral, CNS-penetrant small molecule designed to induce remyelination
实验性的：Phase 1, PRO-1562 Dose level 3
PRO-1562 oral capsule
药品：PRO-1562 Oral Capsules
Oral, CNS-penetrant small molecule designed to induce remyelination
实验性的：Phase 1, PRO-1562 Dose level 4
PRO-1562 oral capsules
药品：PRO-1562 Oral Capsules
Oral, CNS-penetrant small molecule designed to induce remyelination
实验性的：Phase 1, PRO-1562 Dose level 5
PRO-1562 oral capsule
药品：PRO-1562 Oral Capsules
Oral, CNS-penetrant small molecule designed to induce remyelination
实验性的：Phase 1, PRO-1562 Dose level 6
PRO-1562 oral capsule
药品：PRO-1562 Oral Capsules
Oral, CNS-penetrant small molecule designed to induce remyelination
安慰剂比较：Phase 1, Placebo
Placebo oral capsule
药品：Placebo Oral Capsule
Placebo filled capsules that look like the active intervention
实验性的：Phase 2, PRO-1562 Oral Capsules Dose level 1
PRO-1562 low dose level selected from Phase 1 (oral capsule)
药品：PRO-1562 Oral Capsules
Oral, CNS-penetrant small molecule designed to induce remyelination
实验性的：Phase 2, PRO-1562 Oral Capsules Dose level 2
PRO-1562 high dose level selected from Phase 1 (oral capsule)
药品：PRO-1562 Oral Capsules
Oral, CNS-penetrant small molecule designed to induce remyelination
安慰剂比较：Phase 2, Placebo
Placebo oral capsule
药品：Placebo Oral Capsule
Placebo filled capsules that look like the active intervention

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Phase 1 Incidence of ≥Grade 2 treatment-emergent adverse events
大体时间：From enrollment until 7 days post dose
Incidence of treatment-emergent adverse events including clinically significant laboratory abnormalities of ≥Grade 2 in healthy participants
From enrollment until 7 days post dose
Phase 2 Change from baseline P100 VEP latency
大体时间：From enrollment until the end of 6 months of treatment
The change from baseline on visual evoked potential (VEP) in affected eye of RMS patients after 6 months of study treatment
From enrollment until the end of 6 months of treatment

次要结果测量

结果测量
措施说明
大体时间
Area under the concentration-time curve of PRO-1562 (Phase 1)
大体时间：From enrollment until 7 days post dose.
Concentration over time analysis to determine overall exposure to PRO-1562 by dose group
From enrollment until 7 days post dose.
Brain myelin content, change from baseline
大体时间：From enrollment to the end of 6 months of treatment
MRI measurement of brain myelin content in multiple brain regions will be determined as baseline and after 6 months of treatment
From enrollment to the end of 6 months of treatment
Safety Phase 2 Incidence of ≥Grade 2 treatment-emergent adverse events
大体时间：From enrollment until the end of 6-months of treatment
Incidence of treatment emergent adverse events including clinically significant laboratory abnormalities of ≥Grade 2 in RMS patients
From enrollment until the end of 6-months of treatment

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Progentos Therapeutics

调查人员

  • 学习椅：Paul A Frohna, MD, PhD, PharmD、Progentos Therapeutics

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年10月1日

初级完成 (估计的)

2028年12月1日

研究完成 (估计的)

2029年2月1日

研究注册日期

首次提交

2026年9月8日

首先提交符合 QC 标准的

2026年9月11日

首次发布 (实际的)

2026年9月17日

研究记录更新

最后更新发布 (实际的)

2026年9月17日

上次提交的符合 QC 标准的更新

2026年9月11日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • PRO-1562-101

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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