Prophylactic Antimalarial Activity of DB289 in Volunteers

Completed · Phase 1/Phase 2

Conditions studied: Prophylactic Activity Against Malaria

In brief

To evaluate the prophylactic activity of orally administered DB289 against Plasmodium falciparum in non-immune healthy volunteers who are challenged by the bite of five P. falciparum-infected Anopheles stephensi mosquitoes

Key facts

Study ID

NCT00408369

Run by

Immtech Pharmaceuticals, Inc

People needed

19

Starts

2006-11-01

Expected to finish

2007-11-01

Last updated by the study team

2008-01-29

Who can join

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

You may qualify if…

• Age between 18 and 45 years
• BMI between 19 and 30 (Appendix IV)
• Able to provide home address and phone number; work description, address, and phone number; and to provide the name, address, and phone number of a person willing and able to assist the investigators in making contact with the cognate volunteer during the study period
• Able and willing to follow-up intensively for 3 months of scheduled visits
• Post-menopausal or surgically sterilized women
• Score of 80% or more on a written exam to test malaria knowledge and comprehension of the study
• Serum and red cells support growth of P. falciparum in vitro (Appendix V)
• Blood type A or O
• Able and willing to provide written informed consent for screening, HIV testing, and study participation-

You may not qualify if…

• Clinically significant abnormalities on screening examinations
• AST, ALT, bilirubin, hemoglobin, hematocrit, prothrombin time, partial thromboplastin time, or creatinine outside the limits of normal as defined at the time of testing by the Johns Hopkins Medical Laboratories
• laboratory evidence of HIV infection or active viral hepatitis
• G6PD deficiency, or hemoglobin S or C
• Significant medical illnesses requiring systemic treatment and/or hospitalization within one month of enrollment
• History of chronic medical illnesses, significant in the investigators' judgment
• Self-described use of tobacco
• History of alcohol or drug abuse
• Use of prescribed or over-the-counter medications or nutritional supplements within two weeks of enrollment (vitamins, at or below the daily recommended dose, may be taken during the study)
• Women of childbearing potential
• Blood or plasma donation within 2 weeks of enrollment
• History of malaria or residence in a malaria-endemic area
• Allergy to mosquito bites
• Intolerance to chloroquine, Malarone, quinine, quinidine, or tetracycline
• Taken anti-infective drugs or quinine-containing beverages in the week prior to enrollment
• Currently participating in other clinical trials, participated in a drug trial within two weeks of enrollment, or plan to participate in another clinical trial within three months from challenge
• Any factors for which the investigator believes that participation of the volunteer in the study is not appropriate

Where it is running

• Johns Hopkins University School of Medicine — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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