Phase 1 Single Dose Escalation Study of CTB-001 | NCT01647893 | Trialant

Phase 1 Single Dose Escalation Study of CTB-001 | NCT01647893 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CTB-001 or placebo(mannitol) 0.375mg/kg, single-dose	Experimental		Drug: CTB-001
CTB-001 or placebo(mannitol) 0.75mg/kg, single-dose	Experimental		Drug: CTB-001
CTB-001 or placebo(mannitol) 1.5mg/kg, single-dose	Experimental		Drug: CTB-001
CTB-001 or placebo(mannitol) 0.75mg/kg, and dose escalation	Experimental		Drug: CTB-001

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CTB-001	Drug	IV bolus or IV infusion	CTB-001 or placebo(mannitol) 0.375mg/kg, single-dose CTB-001 or placebo(mannitol) 0.75mg/kg, and dose escalation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety	Summary statistics for SAD parts will be prepared for measured values and changes from baseline values for each dose group. Placebo subjects will serve as the control. Summaries of treatment-emergent and clinically important abnormalities in ECG, physical examination, vital signs, and laboratory (clinical chemistry, hematology, coagulation, urinalysis) data will be provided. The incidence of adverse events(AEs) will be tabulated and compared across dose group in the SAD parts.	Up to 7 hours

Contacts/Locations Module