NCT05311215

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

A Randomized, Double-Blind, Placebo-Controlled Single Ascending Dose Escalation Study to Assess the Safety, Pharmacokinetics and Efficacy of SL-1002 in Patients With Limb Spasticity

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Saol Therapeutics Inc · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spasticity

Interventions

Type	Name	Description
DRUG	SL-1002	SL-1002 injectable solution
DRUG	Placebo	Matching placebo injectable solution

Timeline

• Start date: 2022-04-22
• Primary completion: 2023-09-01
• Completion: 2023-09-01
• First posted: 2022-04-05
• Last updated: 2023-09-06

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study