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
Overview
- Phase
- Phase 1
- Intervention
- CTB-001
- Conditions
- Healthy
- Sponsor
- HLB Pharmaceutical Co., Ltd.
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- Safety
- Last Updated
- 13 years ago
Overview
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
Investigators
Eligibility 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
Arms & Interventions
CTB-001 or placebo(mannitol) 0.375mg/kg, single-dose
Intervention: CTB-001
CTB-001 or placebo(mannitol) 0.75mg/kg, single-dose
Intervention: CTB-001
CTB-001 or placebo(mannitol) 1.5mg/kg, single-dose
Intervention: CTB-001
CTB-001 or placebo(mannitol) 0.75mg/kg, and dose escalation
Intervention: CTB-001
Outcomes
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.