DSM265 Prophylaxis of Plasmodium Falciparum Malaria

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

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).

Key facts

Study ID

NCT02562872

Run by

Medicines for Malaria Venture

People needed

24

Starts

2016-03-01

Expected to finish

2017-05-01

Last updated by the study team

2022-01-14

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

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
• Use of any prohibited medication
• Grapefruit or product containing grapefruit from28 days before study medication or throughout the study
• History of drug or alcohol abuse within 12 months prior to dosing, or laboratory evidence of abuse
• Current smoking of more than 10 cigarettes or equivalent per day
• Plan for major surgery between enrolment and study completion

Where it is running

• Fred Hutchinson Cancer Research Center - Prevention Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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