NCT00744133 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Laurens MB, Billingsley P, Richman A, Eappen AG, Adams M, Li T, Chakravarty S, Gunasekera A, Jacob CG, Sim BK, Edelman R, Plowe CV, Hoffman SL, Lyke KE
Successful human infection with P. falciparum using three aseptic Anopheles stephensi mosquitoes: a new model for controlled human malaria infection. PLoS One. 2013 Jul 16;8(7):e68969. doi: 10.1371/journal.pone.0068969. Print 2013.
Lyke KE, Laurens M, Adams M, Billingsley PF, Richman A, Loyevsky M, Chakravarty S, Plowe CV, Sim BK, Edelman R, Hoffman SL
Plasmodium falciparum malaria challenge by the bite of aseptic Anopheles stephensi mosquitoes: results of a randomized infectivity trial. PLoS One. 2010 Oct 21;5(10):e13490. doi: 10.1371/journal.pone.0013490.

An Interventional Plasmodium Falciparum Malaria Challenge Model Utilizing the NF54 Strain of Parasite Transmitted by Aseptic A. Stephensi Mosquitoes to Healthy Malaria-Naïve Adult Volunteers

Details for clinical trial NCT00744133

Clinical trial NCT00744133 - References