FSD Pharma has completed dosing the first cohort of patients in a Phase I clinical trial of Lucid-21-302 (Lucid-MS), a non-immunomodulatory agent, for multiple sclerosis (MS) treatment.
A wholly owned subsidiary of FSD Pharma, Lucid Psycheceuticals will conduct the study of Lucid-MS as a new drug candidate to treat MS.
The first-in-human, placebo-controlled, randomised, double-blind study will include five single-ascending dose (SAD) and two multiple-ascending dose (MAD) cohorts each with eight subjects.
A total of 56 subjects will be randomised into six active and two placebo groups.
Single or multiple doses of Lucid-MS will be given to subjects in the active group while all eight participants of the SAD cohort with food effect will receive Lucid-MS.
Evaluating the safety, tolerability, and pharmacokinetics of the neuroprotective compound, Lucid-MS, in healthy participants under fed and fasted conditions is the primary outcome of the study.
Lucid Psycheceuticals CEO Dr Lakshmi Kotra said: “Our clinical development team and international advisory committee are delighted at the progress of this milestone and completing dosing the first cohort.
“The safety review committee has recommended moving forward with the next cohort dosing, which we are thrilled to say is expected to commence in the next few days.”
A small molecule inhibitor of hypercitrullination, Lucid-MS prevents damage to the myelin sheath surrounding nerve fibres in the central nervous system.