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Phase 1 Single Dose Escalation Study of CTB-001

NCT ID: NCT01647893

Last Updated: 2012-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2012-12-31

Brief Summary

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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

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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CTB-001 or placebo(mannitol) 0.375mg/kg, single-dose

Group Type EXPERIMENTAL

CTB-001

Intervention Type DRUG

IV bolus or IV infusion

CTB-001 or placebo(mannitol) 0.75mg/kg, single-dose

Group Type EXPERIMENTAL

CTB-001

Intervention Type DRUG

IV bolus or IV infusion

CTB-001 or placebo(mannitol) 1.5mg/kg, single-dose

Group Type EXPERIMENTAL

CTB-001

Intervention Type DRUG

IV bolus or IV infusion

CTB-001 or placebo(mannitol) 0.75mg/kg, and dose escalation

Group Type EXPERIMENTAL

CTB-001

Intervention Type DRUG

IV bolus or IV infusion

Interventions

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CTB-001

IV bolus or IV infusion

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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HLB Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kyun-Seop Bae, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

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Asan Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Facility Contacts

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Kyun-Seop Bae, M.D., Ph.D.

Role: primary

Other Identifiers

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CTB-001

Identifier Type: -

Identifier Source: org_study_id