Phase 1 Single Dose Escalation Study of CTB-001

Phase 1

• Conditions: Healthy
• Interventions: Drug: CTB-001

• Registration Number: NCT01647893
• Lead Sponsor: HLB Pharmaceutical Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-07
• Study Start: 2012-07
• Study First Submitted: 2012-07-17
• Study First Submitted QC: 2012-07-19
• Last Update Submitted: 2012-07-19
• Study First Posted: 2012-07-24
• Last Update Posted: 2012-07-24
• Primary Completion: 2012-11
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 33

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CTB-001 or placebo(mannitol) 0.375mg/kg, single-dose	CTB-001	-
CTB-001 or placebo(mannitol) 0.75mg/kg, and dose escalation	CTB-001	-
CTB-001 or placebo(mannitol) 0.75mg/kg, single-dose	CTB-001	-
CTB-001 or placebo(mannitol) 1.5mg/kg, single-dose	CTB-001	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul,, Korea, Republic of