Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SJ000557733 · 1 trial · 1 indication
The parasite reduction ratio (PRR) provides an estimate of the efficacy of an antimalarial treatment and is the ratio of the parasite density between admission and 48 h post antimalarial treatment. The primary efficacy variable is parasite reduction ratio (PRR) of parasites based on qPCR after administration of SJ733. The PRR was estimated using the slope of the optimal fit of the log-linear relationship of the parasitaemia decay. PRR was calculated for each subject using the retrospective 18S rRNA qPCR data. If the model fit was adequate for the subject (defined as overall model p-value \<0.001), the slope and corresponding standard error from the log-linear regression was used to calculate the overall cohort specific PRR.
The safety and tolerability of SJ733 in healthy subjects (men and WNCBP) following infection with blood stage P. falciparum during the IBSM challenge study will be evaluated by observation of occurrence of adverse events.
| Arm | Type | Description |
|---|---|---|
| first dose | EXPERIMENTAL | The dose used in the first cohort was determined on the basis of the safety and PK data generated in the FIM study (NCT02661373) currently ongoing in United States (US) and will be 150 mg. |
| second dose | EXPERIMENTAL | Depending on the pharmacodynamics data (effect of SJ733 on parasitaemia) obtained from this first cohort, the dose in Cohort 2 may be adjusted but will not exceed 600 mg. |
| Name | Type | Description |
|---|---|---|
| (+)-SJ000557733 | DRUG | (+)-SJ000557733 (SJ733), in short SJ733, will be the second PfATP4 inhibitor to enter clinical development after KAE609 (Novartis) which is currently in Phase 2 stage. KAE609 (cipargamin; previously known as NITD609) is a spirotetrahydro-β-carbolines (spiroindolone). KAE609 inhibits QP15C20\_SJ733\_Challenge Protocol\_v2.0\_26July2016 Page 28 of 110 PfATP4, which results in a disruption of parasite sodium homeostasis. Compared to KAE609, SJ733 has the potential to be a very fast acting, antimalarial drug for human therapeutic application and may have a different safety profile in human participants. Finally, SJ733 blocks parasite transmission in vivo at potencies close to those where it is efficacious in blood stages, indicating its potential for transmission blockade in humans. |
Inclusion Criteria: * Adult, male and women of non-child bearing potential (WNCBP as defined in Section 6.17), participants between 18 and 55 years of age inclusive, who do not live alone (from Day 0 until at least the end of the antimalarial drug treatment) and will be contactable and available fo...
SJ000557733 is an investigational small molecule being studied for the treatment of Plasmodium falciparum malaria, a serious infectious disease. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being evaluated for its safety and efficacy in controlled clinical trials.
SJ000557733 is a small molecule being developed to treat Plasmodium falciparum malaria. While the specific molecular target has not been disclosed, the drug is designed to combat the malaria parasite. It is currently in Phase 1 clinical trials to assess its safety and effectiveness in humans.
SJ000557733 is being developed by CNS Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol CNSP. The company is conducting clinical research on this investigational drug for the treatment of Plasmodium falciparum malaria.
SJ000557733 is currently in Phase 1 clinical development. It is an investigational drug and has not received FDA approval. The drug is being studied for the treatment of Plasmodium falciparum malaria, with one completed Phase 1 clinical trial involving 17 participants.
SJ000557733 has one completed clinical trial registered under NCT02867059, titled "SJ733 Induced Blood Stage Malaria Challenge Study." This Phase 1 study enrolled 17 healthy volunteers in Australia and was designed to evaluate the drug's effects in a controlled setting for Plasmodium falciparum malaria.
SJ000557733 is also known as SJ733, as indicated by the clinical trial title "SJ733 Induced Blood Stage Malaria Challenge Study." The drug is being developed by CNS Pharmaceuticals, Inc. for the treatment of Plasmodium falciparum malaria and is currently in Phase 1 clinical development.