Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Artemether-Lumefantrine · 1 trial · 4 indications
Based on their start date(time), AEs will be allocated to the phase during which they started (Screening, Challenge, Rescue). Each AE will therefore be reported in only one phase.
Malaria Clinical Score 14 signs/symptoms frequently associated with malaria will be graded using a 4-point scale (absent: 0; mild: 1; moderate: 2; severe: 3): headache, myalgia (muscle ache), arthralgia (joint ache), fatigue/lethargy, malaise (general discomfort/uneasiness), chills/shivering/rigors, sweating/hot spells, anorexia, nausea, vomiting, abdominal discomfort, fever, tachycardia and hypotension. Malaria clinical score is calculated as the sum of all (14) malaria sign and symptoms scores (maximum score is 42).
For the purpose of this study, 'PCR positivity' is used for the 'protocol-defined PCR positivity'
POSITIVE PARASITAEMIA IS DEFINED AS qPCR OUTCOME \>=250 PARASITES per mL BLOOD.
| Arm | Type | Description |
|---|---|---|
| PfSPZ-DVI challenge and artemether lumefantrine | EXPERIMENTAL | 16 healthy, malaria-naïve males and females, aged 18-55 years, were enrolled in 2 cohorts (8 participants/cohort; a participant may be enrolled in one cohort only). There were two target levels of parasitaemia previously achieved in healthy participants in malaria VIS at other study sites, i.e., 5000 parasites/mL blood in Cohort 1 and 10000 parasites/mL blood in Cohort 2. (Based on observed levels of parasitaemia in Cohort 1, the target threshold for treatment in Cohort 2 was maintained at 5,000 p/mL). qPCR was performed, malaria clinical score assessed twice daily and participants were administered registered antimalarial therapy, i.e., Riamet®, when the following criteria were met: 1. Cohort 1: ≥5000 parasites/mL blood or earlier if a participant has a malaria clinical score \>6 or at Investigator's discretion. 2. Cohort 2: ≥10000 parasites/mL blood or earlier if a participant has a malaria clinical score \>6 or at Investigator's discretion. |
| Name | Type | Description |
|---|---|---|
| Artemether-Lumefantrine 20 Mg-120 Mg Oral Tablet | DRUG | artemether-lumefantrine 6 x of 4 tablets at approximately 0, 8, 24, 36, 48 and 60 h |
| PfSPZ-DVI Challenge | BIOLOGICAL | 3200 P. falciparum Sporozoites by direct venous inoculation (DVI) |
Inclusion Criteria: 1. Informed Consent Form signed voluntarily before any study-related procedure is performed, indicating that the participant understands the purpose of and procedures required for the study and is willing to participate in the study, including administration of registered antima...
Artemether-Lumefantrine is an investigational small molecule being studied for the treatment of malaria, specifically falciparum malaria. It is currently in Phase 1 clinical development. The drug is being evaluated for its safety and efficacy in treating this infectious disease.
Artemether-Lumefantrine is being developed by IQVIA Holdings, Inc., a company traded on the stock exchange under the ticker symbol IQV. The company is conducting clinical research on this drug candidate for the treatment of malaria.
Artemether-Lumefantrine is currently in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The drug is being studied for its potential use in treating falciparum malaria.
Artemether-Lumefantrine has been studied in one completed Phase 1 clinical trial with the identifier NCT04310085. This trial was conducted in Belgium and enrolled 16 healthy volunteers to study blood stage malaria infection after direct venous inoculation of cryopreserved P. falciparum sporozoites.
Artemether-Lumefantrine is a combination of two antimalarial drugs, artemether and lumefantrine. It is being studied as a fixed-dose combination for the treatment of falciparum malaria. The drug is currently in Phase 1 clinical development as an investigational therapy.