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

Part of paid clinical trials in Houston, Texas.

Sponsor
Saol Therapeutics Inc
Study ID
NCT05311215
Phase
PHASE2
Status
Unknown

Conditions

  • Spasticity

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • SL-1002 — DRUG
    SL-1002 injectable solution
  • Placebo — DRUG
    Matching placebo injectable solution

Study Details

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.

Key Dates

First listed
Apr 5, 2022
Start date
Apr 22, 2022
Status verified
Sep 2023
Primary completion
Sep 30, 2023
Completion
Sep 30, 2023

Study Design

Enrollment
32 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: SL-1002
    SL-1002 injectable solution, single dose
  • Placebo Comparator: Matching placebo
    Matching placebo injectable solution, single dose

Primary Outcome Measure

Occurrence of treatment emergent adverse events (TEAEs) overall [ Time Frame: time of study drug administration to end of study visit (day 168) ]

Locations (2)

FacilityCityStateZIPSite coordinators
TIRR Memorial Hermann Research CenterHoustonTexas77030-
Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Houston, TX

By research site
TIRR Memorial Hermann Research Center· Houston, TXMedical College of Wisconsin· Milwaukee, WI

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