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Phase 1 Single Dose Escalation Study of CTB-001

This study is currently recruiting participants.
Verified July 2012 by Chem Tech Research Incorporation
Sponsor:
Information provided by (Responsible Party):
Chem Tech Research Incorporation
ClinicalTrials.gov Identifier:
NCT01647893
First received: July 17, 2012
Last updated: July 19, 2012
Last verified: July 2012
History of Changes
  Purpose

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 Intervention Phase
Healthy
 Drug: CTB-001
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by Chem Tech Research Incorporation:

Primary Outcome Measures:
  • Safety [ Time Frame: Up to 7 hours ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 33
Study Start Date: July 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01647893

Locations
Korea, Republic of
Asan Medical Center Recruiting
Seoul,, Korea, Republic of
Contact: Kyun-Seop Bae, M.D., Ph.D.     82-2-3010-4611     ksbae@amc.seoul.kr    
Sponsors and Collaborators
Chem Tech Research Incorporation
Investigators
Principal Investigator: Kyun-Seop Bae, M.D., Ph.D. Asan Medical Center
  More Information

No publications provided

Responsible Party: Chem Tech Research Incorporation
ClinicalTrials.gov Identifier: NCT01647893     History of Changes
Other Study ID Numbers: CTB-001
Study First Received: July 17, 2012
Last Updated: July 19, 2012
Health Authority: Korea: Food and Drug Administration

ClinicalTrials.gov processed this record on May 23, 2013