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Safety and Preliminary Efficacy of Aleeto in Amyotrophic Lateral Sclerosis

NCT06181526 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-12-26

No results posted yet for this study

Summary

This study is a single-center, randomized, double-blind, placebo parallel-controlled, dose-escalation clinical study. The aim of this study was to evaluate the safety, tolerability, and preliminary effect of Aleeto in adult patients with ALS, and to provide an appropriate dose for the future clinical trial.

Conditions

Interventions

DRUG

Aleeto

According to the groups, patients would be treated with Aleeto via intrathecal injection or intravenous injection, and the specific dosage and administration method of Aleeto will depend on the grouping.

DEVICE

intravenous injection

According to the groups, patients would be treated with Aleeto or placebo +100ml sodium chloride injection via intravenous injection, depend on the grouping

DEVICE

intrathecal injection

According to the groups, patients would be treated with Aleeto or placebo + 8ml sodium chloride injection via intrathecal injection, depend on the grouping.

Sponsors & Collaborators

  • Beijing Tiantan Hospital

    lead OTHER

Principal Investigators

  • Yilong Wang, MD+PhD · Capital Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-15
Primary Completion
2024-10-30
Completion
2024-10-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06181526 on ClinicalTrials.gov