Safety and Causal Prophylactic Efficacy of KAF156 in a Controlled Human Malaria Challenge Model

Novartis

Status and phase: Completed; Phase 1

Conditions: Malaria

Treatments: Drug: Placebo; Drug: KAF156

Study type: Interventional

Funder types: Industry

Identifiers

NCT04072302

CKAF156X2202

Details and patient eligibility

About

This study is designed to investigate the safety and causal prophylactic efficacy of KAF156 in healthy subjects using a controlled human malaria infection model.

Enrollment: 86 patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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86 participants in 12 patient groups, including a placebo group

KAF156 800 mg pre-challenge

Experimental group

Description:

Single dose 800 mg KAF156 oral administration in healthy subjects, prior to exposure to P. falciparum sporozoite-infected mosquitos

Treatment:

Drug: KAF156

Placebo 800 mg pre-challenge

Placebo Comparator group

Description:

Single dose 800 mg placebo oral administration in healthy subjects, prior to exposure to P. falciiparum sporozoite-infected mosquitos

Treatment:

Drug: Placebo

KAF156 800 mg post-challenge

Experimental group

Description:

Single dose 800 mg KAF156 oral administration in heatlhy subjects, after exposure to P. falciparum sporozoite-infected mosquitos

Treatment:

Drug: KAF156

Placebo 800 mg post-challenge

Placebo Comparator group

Description:

Single dose 800 mg placebo oral administration in heatlhy subjects, after exposure to P. falciparum sporozoite-infected mosquitos

Treatment:

Drug: Placebo

KAF156 300 mg post-challenge

Experimental group

Description:

Single dose 300 mg KAF156 oral administration in heatlhy subjects, after exposure to P. falciparum sporozoite-infected mosquitos

Treatment:

Drug: KAF156

Placebo 300 mg post-challenge

Placebo Comparator group

Description:

Single dose 300 mg placebo oral administration in heatlhy subjects, after exposure to P. falciparum sporozoite-infected mosquitos

Treatment:

Drug: Placebo

KAF156 100 mg post-challenge

Experimental group

Description:

Single dose 100 mg KAF156 oral administration in heatlhy subjects, after exposure to P. falciparum sporozoite-infected mosquitos

Treatment:

Drug: KAF156

Placebo 100 mg post-challenge

Placebo Comparator group

Description:

Single dose 100 mg placebo oral administration in heatlhy subjects, after exposure to P. falciparum sporozoite-infected mosquitos

Treatment:

Drug: Placebo

KAF156 20 mg post-challenge

Experimental group

Description:

Single dose 20 mg KAF156 oral administration in heatlhy subjects, after exposure to P. falciparum sporozoite-infected mosquitos

Treatment:

Drug: KAF156

Placebo 20 mg post-challenge

Placebo Comparator group

Description:

Single dose 20 mg Placebo oral administration in heatlhy subjects, after exposure to P. falciparum sporozoite-infected mosquitos

Treatment:

Drug: Placebo

KAF156 50 mg post-challenge

Experimental group

Description:

Single dose 50 mg KAF156 oral administration in heatlhy subjects, after exposure to P. falciparum sporozoite-infected mosquitos

Treatment:

Drug: KAF156

Placebo 50 mg post-challenge

Placebo Comparator group

Description:

Single dose 50 mg Placebo oral administration in heatlhy subjects, after exposure to P. falciparum sporozoite-infected mosquitos

Treatment:

Drug: Placebo