DSM265 Prophylaxis of Plasmodium Falciparum Malaria
Proof-of-concept, Single Center Study in Healthy Adult Volunteers to Investigate Safety, Tolerability, Pharmacokinetics and Prophylactic Activity of Single Dose DSM265 in a Controlled Human Malarial Infection Challenge Either by Direct Venous Inoculation of Plasmodium Falciparum Sporozoites or Mosquito-borne Plasmodium Falciparum
2 other identifiers
interventional
24
1 country
1
Brief Summary
The study is a single centre, randomised, placebo-controlled, double-blind study with DSM265 including up to two cohorts of healthy male and female volunteers aged 18 to 45 years. The study will be conducted into two sequential parts (Cohort 1 and Cohorts 2a and 2b).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy
Started Mar 2016
Longer than P75 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 28, 2015
CompletedFirst Posted
Study publicly available on registry
September 29, 2015
CompletedStudy Start
First participant enrolled
March 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedJanuary 14, 2022
January 1, 2022
1.2 years
September 28, 2015
January 13, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of subjects with positive parasitemia
positive parasitemia detected by qRT-PCR
28 days
Time interval between challenge and the first positive parasitemia
Time from infection to peripheral parasitemia (qRT-PCR) in DSM265 / placebo treated subjects in each cohort given as a geometric mean \[days\]
28 days
Study Arms (6)
Cohort 1 Active DSM265
EXPERIMENTALCohort 1 Placebo
PLACEBO COMPARATORCohort 2a Active DSM265
EXPERIMENTALCohort 2a Placebo
PLACEBO COMPARATORCohort 2b Active DSM265
EXPERIMENTALCohort 2b Placebo
PLACEBO COMPARATORInterventions
DSM265 400 mg single oral dose
Placebo to match DSM265, single oral dose
Direct venous inoculation of 3200 cryopreserved Plasmodium falciparum (NF54 strain) sporozoites
Five single bites by laboratory reared female Anopheles stephensi mosquitoes carrying Plasmodium falciparum
Eligibility Criteria
You may not qualify if:
- Any history of malaria; any severe reactions to mosquito or insect bites; any history of anaphylaxis
- Plans to travel to malaria endemic region during the study period
- Previous participation in any malaria vaccine study or controlled human malaria infection study
- Participation in any other clinical study within 30 days of enrollment or plan to participate in another investigational vaccine/drug research during the study
- Breastfeeding or planning to become pregnant during the time of the study
- Positive Human Immunodeficiency Virus, Hepatitis B or C tests
- Any confirmed/suspected immunosuppressive or immunodeficient state
- History of serious psychiatric condition that may affect participation in the study, or history of convulsions, seizures, or of severe head trauma
- Symptoms, physical signs or laboratory values suggestive of systemic disorders
- History of cancer (except basal cell carcinoma of the skin)
- History of arrhythmias or documented prolonged QTcF-interval (\>450 msec) or 12-lead ECG demonstrating specific abnormalities
- Moderate risk or higher for cardiovascular event within 5 years (\>10%)
- Positive family history in 1st or 2nd degree relative \<50 years for cardiac disease, or history of, or known active cardiac disease
- history of: psoriasis or porphyria which may be exacerbated by chloroquine; splenectomy, or sickle cell anaemia or other red blood cell disorders; allergy or contra-indication to chloroquine or atovaquone-proguanil
- Treatment with an investigational drug within 28 days or 5 half-lives of study medication; use of any drugs or dietary supplements within 7 days or 5 half-lives prior to study medication. Herbal supplements must be discontinued at least 28 days prior to study medication. As an exception, acetaminophen or ibuprofen may be used as approved by the investigator
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medicines for Malaria Venturelead
- Fred Hutchinson Cancer Centercollaborator
- United States Department of Defensecollaborator
- Center for Infectious Disease Researchcollaborator
Study Sites (1)
Fred Hutchinson Cancer Research Center - Prevention Center
Seattle, Washington, 98109, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James G Kublin, MD/MPH
Fred Hutchinson Cancer Research Centre
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2015
First Posted
September 29, 2015
Study Start
March 1, 2016
Primary Completion
May 1, 2017
Study Completion
May 1, 2017
Last Updated
January 14, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share