Safety and Causal Prophylactic Efficacy of KAF156 in a Controlled Human Malaria Challenge Model
NCT ID: NCT04072302
Last Updated: 2019-08-28
Study Results
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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COMPLETED
PHASE1
86 participants
INTERVENTIONAL
2014-09-15
2017-11-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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KAF156 800 mg pre-challenge
Single dose 800 mg KAF156 oral administration in healthy subjects, prior to exposure to P. falciparum sporozoite-infected mosquitos
KAF156
100 mg tablet, 20 mg tablet, 50 mg tablet
Placebo 800 mg pre-challenge
Single dose 800 mg placebo oral administration in healthy subjects, prior to exposure to P. falciiparum sporozoite-infected mosquitos
Placebo
100 mg tablet, 20 mg tablet, 50 mg tablet
KAF156 800 mg post-challenge
Single dose 800 mg KAF156 oral administration in heatlhy subjects, after exposure to P. falciparum sporozoite-infected mosquitos
KAF156
100 mg tablet, 20 mg tablet, 50 mg tablet
Placebo 800 mg post-challenge
Single dose 800 mg placebo oral administration in heatlhy subjects, after exposure to P. falciparum sporozoite-infected mosquitos
Placebo
100 mg tablet, 20 mg tablet, 50 mg tablet
KAF156 300 mg post-challenge
Single dose 300 mg KAF156 oral administration in heatlhy subjects, after exposure to P. falciparum sporozoite-infected mosquitos
KAF156
100 mg tablet, 20 mg tablet, 50 mg tablet
Placebo 300 mg post-challenge
Single dose 300 mg placebo oral administration in heatlhy subjects, after exposure to P. falciparum sporozoite-infected mosquitos
Placebo
100 mg tablet, 20 mg tablet, 50 mg tablet
KAF156 100 mg post-challenge
Single dose 100 mg KAF156 oral administration in heatlhy subjects, after exposure to P. falciparum sporozoite-infected mosquitos
KAF156
100 mg tablet, 20 mg tablet, 50 mg tablet
Placebo 100 mg post-challenge
Single dose 100 mg placebo oral administration in heatlhy subjects, after exposure to P. falciparum sporozoite-infected mosquitos
Placebo
100 mg tablet, 20 mg tablet, 50 mg tablet
KAF156 20 mg post-challenge
Single dose 20 mg KAF156 oral administration in heatlhy subjects, after exposure to P. falciparum sporozoite-infected mosquitos
KAF156
100 mg tablet, 20 mg tablet, 50 mg tablet
Placebo 20 mg post-challenge
Single dose 20 mg Placebo oral administration in heatlhy subjects, after exposure to P. falciparum sporozoite-infected mosquitos
Placebo
100 mg tablet, 20 mg tablet, 50 mg tablet
KAF156 50 mg post-challenge
Single dose 50 mg KAF156 oral administration in heatlhy subjects, after exposure to P. falciparum sporozoite-infected mosquitos
KAF156
100 mg tablet, 20 mg tablet, 50 mg tablet
Placebo 50 mg post-challenge
Single dose 50 mg Placebo oral administration in heatlhy subjects, after exposure to P. falciparum sporozoite-infected mosquitos
Placebo
100 mg tablet, 20 mg tablet, 50 mg tablet
Interventions
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KAF156
100 mg tablet, 20 mg tablet, 50 mg tablet
Placebo
100 mg tablet, 20 mg tablet, 50 mg tablet
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
40 Years
MALE
Yes
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Seattle, Washington, United States
Countries
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References
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Kublin JG, Murphy SC, Maenza J, Seilie AM, Jain JP, Berger D, Spera D, Zhao R, Soon RL, Czartoski JL, Potochnic MA, Duke E, Chang M, Vaughan A, Kappe SHI, Leong FJ, Pertel P, Prince WT; KAF156 Study Team. Safety, Pharmacokinetics, and Causal Prophylactic Efficacy of KAF156 in a Plasmodium falciparum Human Infection Study. Clin Infect Dis. 2021 Oct 5;73(7):e2407-e2414. doi: 10.1093/cid/ciaa952.
Other Identifiers
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CKAF156X2202
Identifier Type: -
Identifier Source: org_study_id
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