A Safety and Tolerability Study of 42037788 (Referred to as CNTO 0007) Compared With Placebo in Patients Who Have Experienced Ischemic Cerebral Infarction (Also Known as Stroke)

Completed

Phase 1 Results N/A

Trial Description

The purpose of this study is to evaluate the safety and tolerability of 42037788 (CNTO 0007) in patients who have suffered a stroke. The study is not designed to establish efficacy, although preliminary explorations will be conducted.

Detailed Description

This is a first-in-human (FIH) study of 42037788 (referred to as CNTO 0007), a cell therapy being tested to see if it may be useful in treating patients with ischemic cerebral infarction also known as stroke. Patients will be randomized (assigned by chance) to receive a single dose of CNTO 0007 or placebo (identical in appearance to CNTO 0007 but does not contain cells) by intravenous (IV) infusion (injection directly into a vein). Patients and study staff will not know if patients are assigned CNTO 0007 or the placebo. The study will be conducted in 2 stages (Stage A and Stage B). In Stage A, the highest dose of CNTO 0007 that does not cause unacceptable side effects, referred to as the maximum tolerated dose (MTD) will be determined to and administered to patients in Stage B of the study. In Stage A, 5 (up to 7) cohorts (groups) of 4-8 patients each will be administered a single IV infusion of CNTO 0007 or placebo 1-5 days (depending on cohort) after stroke (the first cohort of patients will receive the lowest dose of CNTO 0007 or placebo and each subsequent cohort will be administered a higher dose of CNTO 0007 or placebo until the MTD is determined). In Stage B, patients will be administered a single IV infusion of the MTD within a specified number of days after stroke.

Conditions

Interventions

  • CNTO 0007 or placebo (Stage A) Drug
    Intervention Desc: a single IV infusion of a selected dose of CNTO 0007 or placebo administered IV within 1-5 days (depending on cohort) after stroke (first cohort of patients will receive the lowest dose of CNTO 0007 or placebo and each subsequent group will be administered a higher dose (to be determined)
    ARM 1: Kind: Experimental
    Label: 001
    Description: CNTO 0007 or placebo (Stage A) a single IV infusion of a selected dose of CNTO 0007 or placebo administered IV within 1-5 days (depending on cohort) after stroke (first cohort of patients will receive the lowest dose of CNTO 0007 or placebo and each subsequent group will be administered a higher dose (to be determined)
  • CNTO 0007 or placebo (Stage B) Drug
    Intervention Desc: a single IV infusion of the MTD of CNTO 0007 or placebo administered IV within a specified number of days after stroke
    ARM 1: Kind: Experimental
    Label: 002
    Description: CNTO 0007 or placebo (Stage B) a single IV infusion of the MTD of CNTO 0007 or placebo administered IV within a specified number of days after stroke

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary The number and type of adverse events reported Up to 90 days following study drug administration No
Primary Changes in clinical laboratory test values Up to 90 days following study drug administration No
Primary Changes in vital signs measurements Up to 90 days following study drug administration No
Primary Changes in electrocardiograms Up to 90 days following study drug administration No
Secondary Blood concentration of CNTO 0007 At protocol-specified time points on Day 1 No

Sponsors