Healthy
Conditions
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
Interventions
DRUGCTB-001
IV bolus or IV infusion
Sponsors
HLB Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
20 Years to 40 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety | 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. |
Countries
South Korea
Outcome results
None listed