Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PfSPZ Challenge · 1 trial · 1 indication
Number of participants with positive parasitemia defined as first positive quantitative polymerase chain reaction (qPCR) outcome equal or greater than 100 asexual parasites per milliliter (mL) of blood within 28 days of PfSPZ challenge.
Number of participants with positive parasitemia defined as first positive quantitative polymerase chain reaction (qPCR) outcome equal or greater than 100 asexual parasites per milliliter (mL) of blood within 28 days of PfSPZ challenge.
Time to first positive parasitemia was defined as the time (i.e., number of days) from the PfSPZ DVI (i.e., date of DVI PfSPZ) to the first qPCR outcome greater than or equal to (\>=) 100 asexual parasites per milliliter (mL) of blood.
Time to first positive parasitemia was defined as the time (i.e., number of days) from the PfSPZ DVI (i.e., date of DVI PfSPZ) to the first qPCR outcome greater than or equal to (\>=) 100 asexual parasites per milliliter (mL) of blood.
Documented blood stage parasite growth was defined as an increase of qPCR measured asexual parasites per mL compared to the first parasitemia measurement, within 28 days of PfSPZ DVI.
Documented blood stage parasite growth was defined as an increase of qPCR measured asexual parasites per mL compared to the first parasitemia measurement, within 28 days of PfSPZ DVI.
The malaria clinical score consisted of 14 signs/symptoms frequently associated with malaria and graded using a 4-point scale (absent: 0; mild: 1; moderate: 2; severe: 3) and summed to generate a total malaria clinical score (maximum score possible is 42): 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. The minimum score was 0 (no symptoms) and the maximum score was 42 (maximum symptoms). Total scores are reported here.
The malaria clinical score consisted of 14 signs/symptoms frequently associated with malaria and graded using a 4-point scale (absent: 0; mild: 1; moderate: 2; severe: 3) and summed to generate a total malaria clinical score (maximum score possible is 42): 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. The minimum score was 0 (no symptoms) and the maximum score was 42 (maximum symptoms). Total scores are reported here.
Exposure efficacy relationship was analyzed using logistic regression model. Different exposure matrices (AUC0-24, AUC0-168, AUC0-inf, C24 and C168) were analyzed using logistic regression model.
| Arm | Type | Description |
|---|---|---|
| Early liver stage: Pooled Placebo | PLACEBO_COMPARATOR | Participants received single dose of placebo matched to M5717 capsule on Day 1 after 2 hours of Plasmodium falciparum Sporozoite (PfSPZ) (3200 sporozoites per injection) intravenous (IV) inoculation administration on Day 1. |
| Early liver stage: 30 mg M5717 | EXPERIMENTAL | Participants received single dose of M5717 30 mg capsule on Day 1 after 2 hours of PfSPZ (3200 sporozoites per injection) IV inoculation administration on Day 1. |
| Early liver stage: 60 mg M5717 | EXPERIMENTAL | Participants received single dose of M5717 60 mg capsule on Day 1 after 2 hours of PfSPZ (3200 sporozoites per injection) IV inoculation administration on Day 1. |
| Early liver stage: 80 mg M5717 | EXPERIMENTAL | Participants received single dose of M5717 80 mg capsule on Day 1 after 2 hours of PfSPZ (3200 sporozoites per injection) IV inoculation administration on Day 1. |
| Early liver stage: 100 mg M5717 | EXPERIMENTAL | Participants received single dose of M5717 100 mg capsule on Day 1 after 2 hours of PfSPZ (3200 sporozoites per injection) IV inoculation administration on Day 1. |
| Early liver stage: 200 mg M5717 | EXPERIMENTAL | Participants received single dose of M5717 200 mg capsule on Day 1 after 2 hours of PfSPZ (3200 sporozoites per injection) IV inoculation administration on Day 1. |
| Late liver stage: Pooled Placebo | EXPERIMENTAL | Participants received single dose of placebo matched to M5717 capsule on Day 5 after 96 hours of PfSPZ (3200 sporozoites per injection) IV inoculation administration on Day 1. |
| Late liver stage: 60 mg M5717 | EXPERIMENTAL | Participants received single dose of M5717 60 mg capsule on Day 5 after 96 hours of PfSPZ (3200 sporozoites per injection) IV inoculation administration on Day 1. |
| Late liver stage: 100 mg M5717 | EXPERIMENTAL | Participants received single dose of M5717 100 mg capsule on Day 5 after 96 hours of PfSPZ (3200 sporozoites per injection) IV inoculation administration on Day 1. |
| Late liver stage: 200 mg M5717 | EXPERIMENTAL | Participants received single dose of M5717 200 mg capsule on Day 5 after 96 hours of PfSPZ (3200 sporozoites per injection) IV inoculation administration on Day 1. |
| Name | Type | Description |
|---|---|---|
| PfSPZ Challenge | BIOLOGICAL | Participants received 3200 units of Plasmodium falciparum sporozoites by DVI on Day 1. |
| Palcebo | DRUG | Participants received single oral dose of placebo matched to M5717 capsule on Day 1. |
| M5717 30 mg | DRUG | Participants received 30 mg single oral dose of M5717 capsule on Day 1. |
| M5717 60 mg | DRUG | Participants received 60 mg single oral dose of M5717 capsule on Day 1. |
| M5717 80 mg | DRUG | Participants received 80 mg single oral dose of M5717 capsule on Day 1. |
| M5717 100 mg | DRUG | Participants received 100 mg single oral dose of M5717 capsule on Day 1. |
| M5717 200 mg | DRUG | Participants received 200 mg single oral dose of M5717 capsule on Day 1. |
| Placebo | DRUG | Participants received single oral dose of placebo matched to M5717 capsule on Day 5. |
Inclusion Criteria: * Participants who are overtly healthy as determined by medical evaluation, including no clinically significant abnormality identified on physical examination or laboratory evaluation and no active clinically significant disorder, condition, infection or disease that would pose ...
PfSPZ Challenge is an investigational drug being studied in healthy volunteers. It is being evaluated in a Phase 1 clinical trial for its chemoprophylactic activity, meaning it is tested for its ability to prevent malaria infection. The drug is currently in clinical development and is not approved for any indication.
PfSPZ Challenge is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The company is conducting clinical research on this investigational drug in healthy volunteers.
PfSPZ Challenge is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied in a single completed Phase 1 trial that enrolled 39 healthy participants.
PfSPZ Challenge has been studied in one clinical trial with the identifier NCT04250363, titled "Chemoprophylactic Activity of M5717 in PfSPZ Challenge Model." This Phase 1 trial was completed and enrolled 39 healthy volunteers in the Netherlands. The trial was randomized, double-blind, and placebo-controlled.
PfSPZ Challenge is classified as a monoclonal antibody modality. It is being investigated in a clinical trial that is randomized, double-blind, and placebo-controlled, with healthy volunteers as participants. The drug is in Phase 1 development for prophylactic use.