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Phase 1 Single Dose Escalation Study of CTB-001

Sponsor
HLB Pharmaceutical Co., Ltd. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT01647893
Collaborator
(none)
33
Enrollment
1
Location
4
Arms
5
Duration (Months)
6.6
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
33 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Supportive Care
Official Title:
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 Start Date :
Jul 1, 2012
Anticipated Primary Completion Date :
Nov 1, 2012
Anticipated Study Completion Date :
Dec 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 40 Years
Sexes Eligible for Study:
Male
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Asan Medical Center Seoul, Korea, Republic of

Sponsors and Collaborators

  • HLB Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Kyun-Seop Bae, M.D., Ph.D., Asan Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
HLB Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01647893
Other Study ID Numbers:
  • CTB-001
First Posted:
Jul 24, 2012
Last Update Posted:
Jul 24, 2012
Last Verified:
Jul 1, 2012
Additional relevant MeSH terms:
Bivalirudin

Study Results

No Results Posted as of Jul 24, 2012