Single Ascending Dose Study of Oral CPSI-2364 (Semapimod)
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be conducted in healthy male or female subjects using a double-blind,
      randomized, placebo-controlled, single-dose design. Up to 30 subjects will be enrolled; 3
      healthy subjects in Cohorts 1 and 2 (2 active, 1 placebo) and 8 healthy subjects in Cohorts 3
      to 5 (6 active, 2 placebo). The following CPSI-2364 doses are proposed: 1 mg, 10 mg, 30 mg,
      90 mg, and 270 mg.Safety will be evaluated throughout the study and include physical
      examinations, vital signs assessments, 12-lead electrocardiograms (ECGs), routine clinical
      laboratory tests (including blood chemistry, hematology, coagulation, and urinalysis), and
      adverse event (AE) assessments. Vital sign assessments and 12-lead ECGs will be performed
      repeatedly over the 24-hour observation period. Venous blood samples will be taken at
      specified intervals and tested for the presence of CPSI-2364.
    

Detailed description: 
      This study will be conducted in healthy male or female subjects using a double-blind,
      randomized, placebo-controlled, single-dose design. Up to 30 subjects will be enrolled; 3
      healthy subjects in Cohorts 1 and 2 (2 active, 1 placebo) and 8 healthy subjects in Cohorts 3
      to 5 (6 active, 2 placebo). The following CPSI-2364 doses are proposed: 1 mg, 10 mg, 30 mg,
      90 mg, and 270 mg. In Cohort 1 (1 mg) and Cohort 2 (10 mg), the three subjects will all be
      dosed on the same day, with at least 60 minute intervals between dosing. In Cohorts 3 to 5,
      the first two subjects of each cohort (one active, one placebo) will receive their drug on
      the same day with at least a 60-minute interval between dosing, with the remainder of the
      cohort being dosed the next day once these subjects have been assessed. Safety labs, physical
      examination findings, and adverse events available up to and including Day 5 data of each
      cohort will be reviewed by the Investigator, the Study Manager, and the Sponsor (or designee)
      in order to determine the progression of dose escalation. Subjects will not be enrolled in
      the next higher cohort until the dose in the preceding cohort is deemed safe and tolerable.
      Doses will continue to be escalated in subsequent groups until a maximum tolerated dose (MTD)
      is reached, or until a top dose of 270 mg is reached, whichever is sooner. Intermediate and
      repeat dose levels may be administered in addition to or in place of the planned dose levels,
      if it is deemed appropriate to increase the safety or scientific value of this Phase 1
      exploratory study.Safety will be evaluated throughout the study and include physical
      examinations, vital signs assessments, 12-lead electrocardiograms (ECGs), routine clinical
      laboratory tests (including blood chemistry, hematology, coagulation, and urinalysis), and
      adverse event (AE) assessments. Vital sign assessments and 12-lead ECGs will be performed
      repeatedly over the 24-hour observation period.Venous blood samples will be taken at
      specified intervals and tested for the presence of CPSI-2364.
    

Intervention name(s): CPSI-2364 or placebo
Intervention type(s): Drug
Intervention description(s): Single, oral dose of CPSI-2364 or placebo
Other intervention name(s): semapimod
Intervention MeSH terms: Semapimod
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: CPSI2364; Semapimod; Anti TNF alpha; Crohn's Disease; Safety; Tolerability; Pharmacokinetics