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Administration of the malaria inoculum · 1 trial · 1 indication
Seven to ten days after blood feeding, mosquitoes will be dissected to check for oocysts in midgut preparations. For permanent preparations, oocysts will be stained with 0.1% mercurochrome in PBS for 5 to 60 mins then fixed in 1%glutaraldehyde or formaldehyde. Oocysts will be counted per mosquito dissected and recorded. Relationship between parasitemia, gametocytemia and mosquito infection (both oocyst prevalence and intensity) will be determined using generalized-linear mixed models. The number of mosquitoes dying prior to dissection will be recorded.
| Arm | Type | Description |
|---|---|---|
| Piperaquine Phosphate after infected blood malaria challenge | EXPERIMENTAL | Volunteers will receive a dose of 480 mg piperaquine phosphate (PQP) approx. 7 days after a challenge with P. falciparum infected red blood cells. The effects of PQP on gametocyte carriage (assessed by PCR) and infectivity to mosquitos after direct and indirect feeding on blood from volunteers will be assessed. |
| Name | Type | Description |
|---|---|---|
| Administration of the malaria inoculum | BIOLOGICAL | Each participant in the cohort will be inoculated on Day 0 with \~2,800 viable parasites of Plasmodium falciparum-infected human erythrocytes (BSPC) administered intravenously. The threshold for commencement of treatment will be when PCR quantification of all participants is ≥ 5,000 parasites/mL. |
| Piperaquine Phosphate 480 mg | DRUG | When PCR quantification of all participants is ≥ 5,000 parasites/mL, participants will receive a single dose of 480 mg Piperaquine Phosphate |
Inclusion Criteria: Demography: * Adult (male and females) participants between 18 and 55 years of age, inclusive who do not live alone (from Day 0 until at least the end of the anti-malarial drug treatment) and be contactable and available for the duration of the trial (maximum of 6 weeks). * Bod...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GSK plc Sponsored ADR | GSK | 3 | PHASE3 | Tafenoquine, Primaquine, Chloroquine |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE2 | INE963, KAE609, KLU156 |
| 60 Degrees Pharmaceuticals, Inc. | SXTP | 1 | PHASE2 | Tafenoquine |
Administration of the malaria inoculum is an investigational therapy being studied for malaria, an infectious disease. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The therapy is being evaluated in a clinical trial setting to assess its effects.
Administration of the malaria inoculum is being developed by CNS Pharmaceuticals, Inc., a company traded on the stock exchange under the ticker CNSP. The therapy is in Phase 1 clinical development for malaria.
Administration of the malaria inoculum is in Phase 1 clinical development. It is an investigational therapy for malaria and has not been approved for commercial use. The Phase 1 trial has been completed.
Administration of the malaria inoculum has been studied in one completed Phase 1 clinical trial, identified as NCT02431637. The trial, titled "Experimental Falciparum Transmission to Anopheles," enrolled 6 participants in Australia and involved healthy volunteers aged 18 years and older.
Yes, Administration of the malaria inoculum is classified as a monoclonal antibody. It is being developed as an investigational therapy for malaria and is currently in Phase 1 clinical development.
The clinical trial for Administration of the malaria inoculum was not randomized and was not double-blinded. It was an uncontrolled study, meaning there was no control group. The trial enrolled 6 participants and has been completed.