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

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

Study Overview

• Status: Unknown
• Conditions: Healthy
• Intervention / Treatment: Drug: CTB-001

• Study Type: Interventional
• Enrollment (Anticipated): 33
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul,, Korea, Republic of
    • Recruiting
    • Asan Medical Center
    • Contact: Kyun-Seop Bae, M.D., Ph.D.; Phone Number: 82-2-3010-4611; Email: ksbae@amc.seoul.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CTB-001 or placebo(mannitol) 0.375mg/kg, single-dose	Drug: CTB-001; IV bolus or IV infusion
Experimental: CTB-001 or placebo(mannitol) 0.75mg/kg, single-dose	Drug: CTB-001; IV bolus or IV infusion
Experimental: CTB-001 or placebo(mannitol) 1.5mg/kg, single-dose	Drug: CTB-001; IV bolus or IV infusion
Experimental: CTB-001 or placebo(mannitol) 0.75mg/kg, and dose escalation	Drug: CTB-001; IV bolus or IV infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: HLB Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Anticipated): November 1, 2012
• Study Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: July 17, 2012
• First Submitted That Met QC Criteria: July 19, 2012
• First Posted (Estimate): July 24, 2012

Study Record Updates

• Last Update Posted (Estimate): July 24, 2012
• Last Update Submitted That Met QC Criteria: July 19, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Bivalirudin
• Other Study ID Numbers: CTB-001