Prophylactic Antimalarial Activity of DB289 in Volunteers

NCT00408369 | Completed Phase 1

• 1 other identifier: C06-015
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Prophylactic Activity Against Malaria

Keywords

prophylactic; malaria; challenge

Outcome Measures

Primary Outcomes (5)

• The primary endpoint of this study is the appearance of erythrocytic parasites

• (parasitemia), which indicates a prophylaxis failure. Parasitemia will be sought by

• multiple means, including blood culture, polymerase chain reaction (PCR), Quantitative

• Buffy Coat (QBC) analysis, and thick and thin blood smears (detailed methods,

• Appendix II).

Secondary Outcomes (3)

• To distinguish the mechanism of prophylaxis: causal vs suppressive

• To evaluate the pharmacokinetics of DB289 and DB75

• To assess the safety of DB289

Interventions

DB289 DRUG

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Immtech Pharmaceuticals, Inc: lead

Study Sites (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21205-2186, United States

Location

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Theresa A. Shapiro, MD, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 4, 2006
• First Posted: December 6, 2006
• Study Start: November 1, 2006
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: January 29, 2008

Record last verified: 2008-01

Locations

US (1)