BUZZOFF: PHASE 1a, First-in-human, Dose-escalation Study of (+)-SJ000557733 (SJ733), an Oral, Novel Inhibitor of Plasmodium Falciparum Plasma Membrane Protein PFATP4
Why was this study done?
Malaria is a disease caused by a parasite that is passed to humans when an infected mosquito bites a person. The parasite is called Plasmodium falciparum. About 3.4 billion people live in parts of the world where malaria is common. In many countries, malaria is one of the leading causes of illness and death.
This study tested a new drug that attacks and kills the malaria parasite. The drug, called SJ733, was created at St. Jude.
The study’s main goals were to:
- See if SJ733 is safe and tolerated in healthy adults.
- Test to find out how SJ733 is used in the body. This testing looks at how well the body takes the drug into the blood, delivers the drug through the blood, breaks down or processes the drug, and removes it.
- Find the best dose of SJ733 when given with a drug called cobicistat. Cobicistat can “boost” other drugs, which means it could help SJ733 reach higher levels in the blood and/or stay in the body longer.
When was this study done?
The study opened in March 2016 and closed in March 2018.
What did the study consist of?
Participants received one dose of SJ733 with or without cobicistat daily for up to three days. The study participants were healthy volunteers who did not have malaria.
What did we learn from this study?
This study provides the first information on the safety and efficacy of SJ733 in humans. Scientists learned that SJ733 was safe and well-tolerated. This study was also the first to examine the use of another drug to “boost” the levels of the SJ733 drug. The study showed that use of cobicistat to boost SJ733 was safe, well tolerated and increased SJ733 levels in the blood. This information provides the basis to now look at SJ733 with and without cobicistat in patients with malaria
What are the next research steps as a result of this study?
Scientists are continuing to study this drug as a possible malaria therapy.
For more information
Please talk with your doctor about questions or concerns you have as a result of this study.
For more details about this study see: https://www.clinicaltrials.gov/ct2/show/NCT02661373.
Publication generated from this study:
Safety, Tolerability, Pharmacokinetics, and Antimalarial Efficacy of a Novel Plasmodium Falciparum ATP4 Inhibitor SJ733: A First-in-human and Induced Blood-stage Malaria Phase 1a/b Trial. Gaur AH, McCarthy JS, Panetta JC, Dallas RH, Woodford J, Tang L, Smith AM, Stewart TB, Branum KC, Freeman BB 3rd, Patel ND, John E, Chalon S, Ost S, Heine RN, Richardson JL, Christensen R, Flynn PM, Van Gessel Y, Mitasev B, Möhrle JJ, Gusovsky F, Bebrevska L, Guy RK. Lancet Infect Dis. 2020 Aug;20(8):964-975.