A Study of LTX-002 in Adult Participants With Amyotrophic Lateral Sclerosis
Recruiting
Phase 1
Phase 2
Interventional Study
Amyotrophic Lateral Sclerosis
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 56 (estimated)
- Sponsor
- Leal Therapeutics, Inc · Industry
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About This Trial
This study will examine what happens when patients with amyotrophic lateral sclerosis (ALS) are given an investigational medication (study drug) known as LTX-002. Specifically, the researchers will be looking at safety, tolerability (if someone has any side effects from the drug), pharmacokinetics (what the body does to the study drug) and pharmacodynamics (what the study drug does to the body). T…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Diagnosis of ALS per Gold Coast criteria
* ALS symptom onset less than 36 months prior to Screening
* Slow vital capacity ≥ 50% of predicted value
* Body mass index ≥18 and ≤40 kg/m2
Exclusion Criteria:
* Current evidence or history of a clinically significant medical condit…
Contacts