Phase II Study to Assess Safety, Pharmacokinetics and Efficacy of SL-1002 for Limb Spasticity

Summary

This is a randomized, double-blind, placebo-controlled single ascending dose escalation study intended to assess the safety, pharmacokinetics and efficacy of single treatment of SL-1002 in patients with mild to severe limb spasticity. The study will enroll 4 cohorts of 8 patients per cohort for a total of 32 patients. Patients will be randomized to receive either SL-1002 or placebo in a 3:1 ratio. The study period will be up to 26 weeks inclusive of a screening period of up to 2 weeks.

Timeline

Start

2022-04-22

Primary completion

2023-09

Completion

2023-09

Outcome

Met primary endpoint

release “SL-1002 demonstrated a favorable safety profile in adult patients with limb spasticity, achieving the primary safety endpoint of this first-in-human study.” saolrx.com ↗

Drugs

Indications

No indication recorded.