A two-part, randomized, double-blind, placebo-controlled, single-center study to evaluate the safety and causal prophylactic efficacy of KAF156 in a controlled human malaria challenge model

Phase 2

Withdrawn

Conditions: malaria
Plasmodium falciparum
10037072

Registration Number: NL-OMON38223

Lead Sponsor: ovartis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 126

Inclusion Criteria

• Written informed consent must be obtained before any assessment is performed.
• Healthy male subjects aged 18 to 35 years of age included, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
• At screening and baseline, vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed in the sitting position after the subject has rested for at least three minutes, and again (when required) after three minutes in the standing position. Sitting vital signs should be within the normal range.
• Subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 30 kg/m2. BMI = Body weight (kg) / [Height (m)]2.
• Availability and willingness to comply with the study protocol for the duration of the study, including attendance of all study visits.
• Agreement to inform the General Practitioner and to sign a request to release medical information concerning contraindications for participation in the study.
• Able to communicate well with the investigator, to understand and comply with the requirements of the study.

Exclusion Criteria

• Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days, whichever is longer; or longer if required by local regulations.
• A history of clinically significant ECG abnormalities
• Known history or current clinically significant arrhythmias.
• An estimated 10-year risk of fatal cardiovascular disease >=5%, according to the Systematic Coronary Risk Evaluation (SCORE) system.
• Known family history or known presence of long QT syndrome or Torsades de Pointes.
• Sexually active males must use a condom during intercourse while taking drug and for at least 4 weeks (>5 times the study drug terminal half-lives) after stopping study medication and should not father a child in this period.
• History of malaria or residence in a malaria-endemic area over a period of 6 months before study entry.
• Contraindications to Malarone® or chloroquine, including hypersensitivity or treatment taken by the volunteer that interferes with Malarone® or chloroquine.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including functional asplenia or history of spleenectomy.
• History of bleeding disorders, blood dyscrasias, including sickle cell anemia, sickle cell trait, thalassemia, thalassemia trait, or G6PD deficiency.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome variable is the number of subjects that become infected<br /><br>with malaria. A malaria infection is defined as:<br /><br>1. Two consecutive positive real-time qPCR result (defined as >500 parasites<br /><br>per mililiter) in a patient with a temperature <38.0 degrees Celsius.<br /><br>2. One positive real-time qPCR result in a subject with a temperature >=38.0<br /><br>degrees Celsius.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Prophylactic Efficacy assessments: quantative PCR (qPCR) analysis.<br /><br>Safety assessments<br /><br>• Physical examination<br /><br>• Vital signs<br /><br>• Height and weight<br /><br>• Laboratory evaluations<br /><br>• Hematology<br /><br>• Clinical chemistry<br /><br>• Urinalysis<br /><br>• ECG </p><br>