Trial | NCT01647893  Report issue

Title

Phase 1 Single Dose Escalation Study of CTB-001
A Phase 1 Clinical Study, Randomized, Double-blind, Placebo-controlled, Single-dose, Dose Escalation Study of the Safety and Pharmacokinetic/Pharmacodynamic Profiles of CTB-001 Intravenously Administered in Healthy Male Subjects

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    33
A Phase 1 Clinical Study, Randomized, Double-blind, Placebo-controlled, Single-dose, Dose Escalation Study of the Safety and Pharmacokinetic/Pharmacodynamic Profiles of CTB-001 Intravenously Administered in Healthy Male Subjects
Study Started
Jul 31
2012
Primary Completion
Nov 30
2012
Anticipated
Study Completion
Dec 31
2012
Anticipated
Last Update
Jul 24
2012
Estimate

Drug CTB-001

IV bolus or IV infusion

CTB-001 or placebo(mannitol) 0.375mg/kg, single-dose Experimental

CTB-001 or placebo(mannitol) 0.75mg/kg, single-dose Experimental

CTB-001 or placebo(mannitol) 1.5mg/kg, single-dose Experimental

CTB-001 or placebo(mannitol) 0.75mg/kg, and dose escalation Experimental

Criteria 

Inclusion Criteria:

Adult males aged 20 to 40 years at screening.
Be able to understand the objective, method of the study, the characteristics of investigational drug, and comply with the requirement of the study. Subject must provide written informed consent prior to study participation.

Exclusion Criteria:

History or presence of liver, kidney, or nervous system disease, respiratory disorders, endocrinological disorders, hemato-oncologic, cardiovascular or psychiatric or cognitive disorders.
History of gastrointestinal disorders (bleeding, ulceration, hemorrhoids, piles) or disorders of absorption, distribution, metabolism, excretion.
History of known hypersensitivity to drugs including CTB-001
No Results Posted