Status:
COMPLETED
Safety and Causal Prophylactic Efficacy of KAF156 in a Controlled Human Malaria Challenge Model
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Malaria
Eligibility:
MALE
18-40 years
Phase:
PHASE1
Brief Summary
This study is designed to investigate the safety and causal prophylactic efficacy of KAF156 in healthy subjects using a controlled human malaria infection model.
Eligibility Criteria
Inclusion
- \- Healthy male subjects,aged 18 to 40 years of age included and in good health as determined by past medical history, physical examination, vital signs, ECG, and laboratory tests
Exclusion
- History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
- Known history or current clinically significant ECG abnormalities or arrhythmias.
- Symptoms, physical signs and laboratory values suggestive of systemic disorders including renal, hepatic, cardiovascular, pulmonary, skin, immunodeficiency, psychiatric, or other conditions which could interfere with the interpretation of the study results or compromise the health of the subjects.
- Sexually active males must use a condom during intercourse while taking drug and for al least 4 weeks after stopping study medication and should not father a child during this period.
- History of malaria or residence in a malaria-endemic area over a period of 6 months before study entry. - Any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk or render the subject unable to meet requirements of the protocol.
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
September 15 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 29 2017
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT04072302
Start Date
September 15 2014
End Date
November 29 2017
Last Update
August 28 2019
Active Locations (1)
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1
Novartis Investigative Site
Seattle, Washington, United States, 98109