A pilot study to characterise the in vivo safety and infectivity of a Plasmodium falciparum 3D7-GL master cell bank in healthy subjects

Phase 1

Completed

• Conditions: Malaria; Infection - Other infectious diseases

• Registration Number: ACTRN12619001085167
• Lead Sponsor: QIMR Berghofer Medical Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-06
• Study Completion: 2019-12-18
• Last Update Posted: 3 March 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 2

Inclusion Criteria

1.Adult male subjects between 18 and 55 years of age inclusive, who do not live alone (from inoculation day until the end of the antimalarial treatment) and will be contactable and available for the duration of the trial and up to 2 weeks following the End of Study visit.
2.Body weight minimum 50 kg, body mass index between 18 and 32 kg/m2, inclusive.
3.Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).
4.Normal standard 12-lead ECG after 5 minutes resting in supine position.
5.Laboratory parameters within the normal range, unless the Investigator considers an abnormality to be clinically irrelevant for healthy subjects enrolled in this study.
6.Must be able to lie supine and still for the duration of the PET/MRI image acquisition.

Exclusion Criteria

1.Subject with Rh (D) Negative Blood Group
2.Any history of malaria or participation in a previous malaria challenge study.
3.Must not have travelled to or lived (>2 weeks) in a malaria-endemic region during the past 12 months or planned travel to a malaria-endemic region during the course of the study.
4.Has evidence of increased cardiovascular disease risk.
5.History of splenectomy.
6.Presence of acute infectious disease or fever (e.g., sublingual temperature greater than or equal to 38.5 degrees C) within the 5 days prior to inoculation with malaria parasites.
7.Evidence of acute illness within the 4 weeks prior to screening that the Investigator deems may compromise subject safety.
8.Subject has a clinically significant disease or any condition or disease that might affect drug absorption, distribution or excretion, e.g. gastrectomy, diarrhoea.
9.Participation in any investigational product study within the 12 weeks preceding the study.
10.Blood donation of any volume within 1 month before inclusion, or participation in any research study involving blood sampling (more than 450 mL/unit of blood), or blood donation to a blood bank during the 8 weeks prior to the treatment drug dose in the study.
11.Subject who has ever received a blood transfusion.
12.Any vaccination within the last 28 days.
13.Any recent (less than 6 weeks) or current systemic therapy with an antibiotic or drug with potential antimalarial activity (i.e. chloroquine, piperaquine, benzodiazepine, flunarizine, fluoxetine, tetracycline, azithromycin, clindamycin, doxycycline etc.)
14.Cardiac/QT risk
15.Known hypersensitivity to artesunate or any of its excipients, artemether or other artemisinin derivatives, piperaquine, atovaquone/proguanil hydrochloride, primaquine, or 4-aminoquinolines.
16.Unwillingness to abstain from consumption of grapefruit or Seville oranges from inoculation day until end of antimalarial treatment.
17.Significant previous radiation exposure

Study & Design

• Study Type: Interventional
• Study Design: Not specified