Plasmodium Falciparum Malaria Clinical Trial
Official title:
A Phase1 Interventional Sequential Single Site Study to Characterize the Effectiveness of Oral KAE609 in Reducing Asexual & Sexual Blood-stage P. Falciparum Following Inoculation in Healthy-volunteers & Subsequent Infectivity to Mosquitoes
Verified date | July 2019 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a single-center open label study conducted in multiple sequential cohorts using Induced Blood Stage Malaria infection in healthy volunteers to characterize the effectiveness of KAE609 against sexual and asexual blood stage forms of Plasmodium falciparum. This study is divided in 2 parts (Part A and part B). A total of 8 healthy volunteers per cohort will be enrolled. Based on the results of Part A, Part B will be undertaken to evaluate the effect of KAE609 following pretreatment with Piperaquine on sexual stage/gametocytemia and its activity as an inhibitor of onward transmission to mosquito vectors using experimental mosquito feeding assays.
Status | Terminated |
Enrollment | 8 |
Est. completion date | September 2015 |
Est. primary completion date | September 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility |
Inclusion Criteria: 1. Written informed consent must be obtained before any assessment is performed. 2. Male and females participants between 18 and 55 years of age. Female participants between 18 and 55 years of age have to be of non-child bearing potential. 3. Body weight, minimum 50.0 kg, body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive. 4. Certified as healthy by a comprehensive clinical assessment. 5. Normal standard 12-lead electrocardiogram (ECG). 6. Laboratory parameters within the normal range. Exclusion Criteria: 1. Any history of malaria or participation to a previous malaria challenge study 2. Spent more than four weeks in a malaria-endemic country during the past 12 months or planned travel to a malaria endemic area during the course of the study 3. Has evidence of increased cardiovascular disease risk 4. History of splenectomy 5. Presence or history of drug hypersensitivity, or allergic disease diagnosed 6. Presence of current or suspected serious chronic diseases 7. History of malignancy of any organ system 8. Presence of acute infectious disease or fever (e.g., sub-lingual temperature - 38.5°C) within the five days prior to inoculation with malaria parasites. 9. Participation in any investigational product study within the 12 weeks preceding the study. 10. Participant who has ever received a blood transfusion. 11. History or presence of alcohol abuse 12. Any vaccination within the last 28 days. 13. Any corticosteroids, anti-inflammatory drugs, immunomodulators or anticoagulants. 14. Any recent (< 1 month) or current systemic therapy with an antibiotic or drug with potential antimalarial activity (including chloroquine, piperaquine, tetracycline, azithromycin, clindamycin, hydroxychloroquine,). 15. Medicinal products that are known to prolong the QTc interval. 16. Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen, antihepatitis B core antibodies (anti-HBc Ab), anti-hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab). 17. Known severe reaction to mosquito bites other than local itching and redness |
Country | Name | City | State |
---|---|---|---|
Australia | Novartis Investigative Site | Brisbane | Queensland |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals | Medicine for Malaria Venture |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Parasitic count in blood by Polymerase Chain Reaction | Clearance of Plasmodium falciparum asexual and sexual blood stage parasites from the blood of healthy subjects in the Induced Blood Stage Malaria Challenge model | 36 days | |
Secondary | Plasma Pharmacokinetics (PK) of KAE609: Area Under the Plasma Concentration-time Curve (AUC) | It will be measured by Area Under the Concentration-Time Curve (AUC) from the time of dosing to the last quantifiable concentration | Day 1: 0, 1, 2, 3, 4, 8, 12, 16 hours, then 24, 36, 48, 72, 96 and 120 hours post dose Days 2 to 6, Day 15 0, 12 hours post dose then 24, 48, 72, 96 and 120 hours post dose Day 16 to Day 20 | |
Secondary | Safety and Tolerability as measured by adverse events (including serious) for incidence, KAE609 (and inoculum) relatedness and severity | Adverse events (including serious) will be recorded during the study and will be rated according to incidence, relation to study drug (inoculum) and severity | From day of screening until end of study (day 36) |
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