Prophylactic Antimalarial Activity of DB289 in Volunteers

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Immtech Pharmaceuticals, Inc
• Treatments: Antimalarials; Pafuramidine

Criteria

Inclusion Criteria:

• 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-

Exclusion Criteria:

• 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