DRUG
CTB-001
IV bolus or IV infusion
Phase 1 Single Dose Escalation Study of CTB-001
Status
Unknown
Phase
Phase 1
Enrollment
33
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Jul 24, 2012
Study start
Jul 2012
Primary completion
Nov 2012
Study completion
Dec 2012
Results posted
Not reported
Registry updated
Jul 24, 2012
Outcomes
What the study measures.
Primary outcomes
Safety
Time frame · Up to 7 hours
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.
Secondary outcomes
Not reported in the indexed record.
Eligibility
Who can take part.
- Minimum age
- 20 Years
- Maximum age
- 40 Years
- Sex
- MALE
- Healthy volunteers
- Yes
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
Study locations
1 registered sites.
South Korea. Showing up to 24 locations stored in the fast local snapshot.
Asan Medical Center
Seoul, South Korea
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.