Effectiveness of KAE609 in Reducing Asexual & Sexual Blood-stage P.Falciparum Infection & Infectivity to Mosquitos

• Status: Terminated
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Collaborator: Medicine for Malaria Venture
• Treatments: Piperaquine

Criteria

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