CTRI/2023/10/058660进行中（未招募）2 期
A phase 2, proof-of-concept, placebo controlled, randomized, multi-centre, double blind study of ZYIL1 to evaluate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics in patients with Amyotrophic Lateral Sclerosis (ALS) - NI
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Male and/or female patients aged between 18 and 80 years (inclusive at screening).
- •2. Diagnosis of probable or definite ALS, according to the revised version of the El Escorial
- •World Federation of Neurology criteria. Refer Appendix III - El Escorial Criteria.
- •3. Time since onset# of first symptom of ALS =9 months
- •4. Slow Vital Capacity (SVC) = 50% of the predicted value
- •5. Be able to swallow the study capsules during study
- •6. Either not currently receiving riluzole or on a stable dose of riluzole for at least 4 weeks
- •before the screening visit. Participants receiving riluzole are expected to remain on the
- •same dose throughout the duration of the study
- •7. Either not currently receiving edaravone or on edaravone treatment. Participants
- •receiving edaravone must have completed at least 1 cycle of treatment before the
- •screening visit and are expected to continue with stable dose edaravone treatment
- •throughout the duration of the study
排除标准
- •1)With significant cognitive impairment, psychiatric disease, other neurodegenerative
- •disorder (e.g., Parkinson disease or AD), substance abuse other causes of neuromuscular weakness, or any other condition that would make the participants unsuitable for
- •participating in the study or could interfere with assessment or completing the study in
- •the opinion of the Investigator
- •2. History of recent serious infection (e.g., pneumonia, septicemia) within 4 weeks of the
- •screening visit; infection requiring hospitalization or treatment with IV antibiotics,
- •antivirals, or antifungals within 4 weeks of screening; or chronic bacterial infection (such
- •as tuberculosis) deemed unacceptable as per the Investigator’s judgment
- •3. With active herpes zoster infection within 2 months prior to the screening visit
- •4. A documented history of attempted suicide within 6 months prior to the screening visit,
- •or in the Investigator’s judgment are at risk for a suicide attempt
- •5. History of unstable or severe cardiac, pulmonary, oncological, hepatic, or renal disease
- •or another medically significant illness other than ALS precluding their safe
- •participation in this study
- •6. Participants who are pregnant or are currently breastfeeding
- •7. A known history of allergy to any ingredients of ZYIL1
- •8. Patients taking concomitant medicines within 7 days or 5 half-lives of the medication
- •(whichever is longer) prior to first dose of study drug administration till end of the study,
- •which are substrate of CYP1A2 enzymes (e.g., alosetron, caffeine, duloxetine,
- •melatonin, ramelteon, tasimelteon, tizanidine etc.) and CYP2B6 enzymes (e.g.,
- •bupropion, efavirenz etc.).
- •9. Use of any steroids, colchicine or anti-IL-1 inhibitors within 7 days or 5 half-lives of the
- •medication (whichever is longer) prior to first dose of study drug administration.
- •10. Use of any investigational drugs concurrently or within 4 weeks or 5 half-lives
- •(whichever is longer), prior to first dose of study drug administration.
- •11. Any clinically significant and/or laboratory significant value or other instability that
- •would prevent the patient from participating in the study as determined by the
- •Investigator.
- •12. Received a live vaccine within 14 days before the screening visit or planning to receive
- •during the study
- •13. Participants who have received stem cell or gene therapy for ALS at any time in the past
研究者
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