A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study of SUN-627 to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Impact on Measures of Neuroinflammation in the Central Nervous System in Participants With Non-Active Progressive Multiple Sclerosis (SPMS/PPMS)

Sundance Biosciences, Inc.

Summary

The goal of this Phase 2 clinical trial is to investigate the safety and tolerability of SUN-627 in men and women aged 18-70 years old with a diagnosis of non-active SPMS/PPMS.

Description

This Phase 2a, randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and impact on measures of neuroinflammation in the central nervous system (CNS) of SUN-627 administered at 2 dose levels in participants with non-active SPMS/PPMS.

Eligibility

Age range: 18–70 years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: 1. Aged 18-70, inclusive 2. Diagnosis of PPMS or non-active SPMS 3. No MS relapses in the past 2 years 4. Evidence that MS has continued to get worse over time 5. A level of disability that fits the study requirements Exclusion Criteria: 1. Use of certain medications or treatments before the study, or need for these treatments during the study 2. Current participation in another research study 3. Certain abnormal heart rhythm findings on ECG or other heart conditions that may increase risk 4. Certain serious or unstable medical conditions that could make the study unsafe…

A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study of SUN-627 to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Impact on Measures of Neuroinflammation in the Central Nervous System in Participants With Non-Active Progressive Multiple Sclerosis (SPMS/PPMS)

Summary

Description

Eligibility

Interventions

Locations (3)