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
1 other identifier
interventional
33
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Jul 2012
Typical duration for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 17, 2012
CompletedFirst Posted
Study publicly available on registry
July 24, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedJuly 24, 2012
July 1, 2012
4 months
July 17, 2012
July 19, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (4)
CTB-001 or placebo(mannitol) 0.375mg/kg, single-dose
EXPERIMENTALCTB-001 or placebo(mannitol) 0.75mg/kg, single-dose
EXPERIMENTALCTB-001 or placebo(mannitol) 1.5mg/kg, single-dose
EXPERIMENTALCTB-001 or placebo(mannitol) 0.75mg/kg, and dose escalation
EXPERIMENTALInterventions
IV bolus or IV infusion
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Asan Medical Center
Seoul, South Korea
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Kyun-Seop Bae, M.D., Ph.D.
Asan Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2012
First Posted
July 24, 2012
Study Start
July 1, 2012
Primary Completion
November 1, 2012
Study Completion
December 1, 2012
Last Updated
July 24, 2012
Record last verified: 2012-07