Hyperparathyroidism, Secondary Clinical Trial
Official title:
A Double-Blind, Randomized, Placebo-Controlled, Rising Single Intravenous Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of KAI-4169 in Healthy Male Volunteers
Verified date | August 2010 |
Source | KAI Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | Australia: Human Research Ethics Committee |
Study type | Interventional |
The purpose of this study is to characterize the safety and tolerability of KAI-4169 in healthy young males.
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 |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
KAI Pharmaceuticals | Nucleus Network Ltd |
Australia,
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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