Safety, Tolerability and Pharmacokinetics of KAI-4169 in Healthy Male Volunteers

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01134549
• Other study ID #: KAI-4169-001
• 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

• Hyperparathyroidism
• Hyperparathyroidism, Secondary

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