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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01134549
Other study ID # KAI-4169-001
Secondary ID
Status Completed
Phase Phase 1
First received May 28, 2010
Last updated August 20, 2010
Start date June 2010
Est. completion date August 2010

Study information

Verified date August 2010
Source KAI Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority Australia: Human Research Ethics Committee
Study type Interventional

Clinical Trial Summary

The purpose of this study is to characterize the safety and tolerability of KAI-4169 in healthy young males.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date August 2010
Est. primary completion date July 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Male between 18 and 45 years of age who have provided written informed consent

- Subject is judged to be in good health based on medical history, physical examination, and routine laboratory tests

Exclusion Criteria:

- History or presence of any significant acute or chronic illness (e.g., cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, or neurologic disease) according to the investigator

- History of any ongoing medical condition requiring treatment with prescription medication

- History of asthma, severe allergies including skin reactions or prior anaphylactic type reactions

- Clinically significant abnormalities on screening clinical examination or laboratory safety tests

- History of drug or alcohol abuse

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
KAI-4169
Single IV injection 0.2, 2, 5, 10, 20, 40, or 60 mg
Saline
Single IV injection

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
KAI Pharmaceuticals Nucleus Network Ltd

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety and tolerability of rising single doses of KAI-4169 by IV injection in healthy male subjects 1 week Yes
Secondary Pharmacodynamics of rising single doses of KAI-4169 by IV injection in healthy male subjects 48 hours No
Secondary Pharmacokinetics of rising single doses of KAI-4169 by IV injection in healthy male subjects 48 hours No
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