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Phase 1Completed

Study of SPG302 in Healthy Volunteers and ALS Participants

A Phase 1/2a, Randomized, Double Blind, Placebo Controlled, Single and Multiple Dose Escalation Study in Healthy Volunteers and an Expansion Cohort in Adult Participants With Amyotrophic Lateral Sclerosis (ALS) to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SPG302

Sponsor
Spinogenix (Industry)
Enrolment
88 enrolled
Conditions
Amyotrophic Lateral Sclerosis
Interventions
SPG302; Placebo
Ages
adults
Registry
NCT05882695

Full record on ClinicalTrials.gov

From the registry

The first-in-human Phase 1 study described herein will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SPG302 in healthy volunteers and ALS participants

Primary outcomes

  • Safety and tolerability in healthy volunteers (SAD cohort)
  • Safety and tolerability in healthy volunteers (SAD food effect cohort)
  • Safety and tolerability in healthy volunteers (MAD cohort)
  • Safety and tolerability in participants with ALS

History

  1. Last registry update

  2. Primary completion

  3. Started

  4. Registered