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.

Per-protocol (PP) analysis set included all SAF participants who comply with the protocol and meet no criteria that could impact the proper evaluation of key objectives of the study.

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.

PP analysis set included all SAF participants who comply with the protocol and meet no criteria that could impact the proper evaluation of key objectives of the study.

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.

PP analysis set included all SAF participants who comply with the protocol and meet no criteria that could impact the proper evaluation of key objectives of the study. Here, "Overall Number of Participants Analyzed" signifies those participants who had positive parasitemia.

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.

PP analysis set included all SAF participants who comply with the protocol and meet no criteria that could impact the proper evaluation of key objectives of the study. Here, "Overall Number of Participants Analyzed" signifies those participants who had positive parasitemia.

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.

PP analysis set included all SAF participants who comply with the protocol and meet no criteria that could impact the proper evaluation of key objectives of the study.

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.

PP analysis set included all SAF participants who comply with the protocol and meet no criteria that could impact the proper evaluation of key objectives of the study.

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.

PP analysis set included all SAF participants who comply with the protocol and meet no criteria that could impact the proper evaluation of key objectives of the study. Here, "Number analyzed" signifies those participants who were evaluable for this outcome at specified timepoint.

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.

PP analysis set included all SAF participants who comply with the protocol and meet no criteria that could impact the proper evaluation of key objectives of the study. Here, "Number analyzed" signifies those participants who were evaluable for this outcome at specified timepoint.

An adverse event (AE) was defined as any untoward medical occurrence in a participant administered with study drug which does not necessarily had a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAE was defined as AEs starting or worsening after the first intake of the study drug. TEAEs included both serious TEAEs and non-serious TEAEs. Treatment-related TEAEs: reasonably related to study intervention.

SAF included all ITT participants, who have been inoculated using a Direct Intravenous Inoculation (DVI) of PfSPZ and who were administered one dose of study intervention (M5717 or placebo).

Severity of adverse events (AE) were assessed by the investigator per the Qualitative Toxicity Scale. Grade 1= Mild, Grade 2=Moderate, Grade 3=Severe. The number of participants that experienced at least one solicited local TEAE were summarized by grade. The term TEAE is defined as AEs starting or worsening after the first intake of the study drug. TEAEs include both Serious TEAEs and non-serious TEAEs. Number of participants with Grade=1, Grade=2 and 3 were reported.

SAF included all ITT participants, who have been inoculated using a Direct Intravenous Inoculation (DVI) of PfSPZ and who were administered one dose of study intervention (M5717 or placebo).

Laboratory assessments included hematology, biochemistry, urinalysis, and coagulation. Number of participants with clinically significant changes from baseline in laboratory values which were deemed clinically significant by the investigator were reported.

SAF included all ITT participants, who have been inoculated using a DVI of PfSPZ and who were administered one dose of study intervention (M5717 or placebo).

Vital signs included oral body temperature, height, weight, systolic blood pressure, diastolic blood pressure, and pulse rate. Number of participants with clinically significant changes from baseline in Vital signs which were deemed clinically significant by the investigator were reported.

SAF included all ITT participants, who have been inoculated using a DVI of PfSPZ and who were administered one dose of study intervention (M5717 or placebo).

Single 12-lead ECG was obtained as outlined using an ECG machine that automatically calculates the heart rate and measures PR, QRS, and QT intervals. Number of participants with clinically significant changes from baseline in ECG which were deemed clinically significant by the investigator were reported.

SAF included all ITT participants, who have been inoculated using a DVI of PfSPZ and who were administered one dose of study intervention (M5717 or placebo)

AUC0-inf was calculated by combining AUC0-t and AUCextra. AUC extra represents an extrapolated value obtained by Clast/ λz, where Clast is the calculated blood concentration at the last sampling time point at which the measured blood concentration is at or above the Lower Limit of quantification (LLQ) and λz is the apparent terminal rate constant determined by log-linear regression analysis of the measured blood concentrations of the terminal log-linear phase.

PK analysis set included all participants, who received 1 dose of M5717, had no clinically important protocol deviations/important events affecting PK, & provide at least 1 measurable post-dose concentration. Data was not available for 'Early liver stage: 30 mg M5717' arm as no participants were considered evaluable because of limited number of samples collected to characterize the elimination rate constant (lambda z) needed for calculation of AUC0-inf.

Area under the blood concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule.

Pharmacokinetic analysis set included all participants, who received one dose of M5717, have no clinically important protocol deviations or important events affecting PK, and provide at least one measurable post-dose concentration.

AUC from time zero to 24 hours post dose, calculated using the mixed log linear trapezoidal rule (linear up, log down) using the nominal dosing interval.

Pharmacokinetic analysis set included all participants, who received one dose of M5717, have no clinically important protocol deviations or important events affecting PK, and provide at least one measurable post-dose concentration.

AUC from time zero to 168 hours post dose. Calculated using the mixed log linear trapezoidal rule (linear up, log down) using the nominal dosing interval.

Pharmacokinetic analysis set included all participants, who received one dose of M5717, have no clinically important protocol deviations or important events affecting PK, and provide at least one measurable post-dose concentration.

Cmax was obtained directly from the concentration versus time curve.

Pharmacokinetic analysis set included all participants, who received one dose of M5717, have no clinically important protocol deviations or important events affecting PK, and provide at least one measurable post-dose concentration.

Blood samples for PK analysis of C24 of M5717 was reported.

Pharmacokinetic analysis set included all participants, who received one dose of M5717, have no clinically important protocol deviations or important events affecting PK, and provide at least one measurable post-dose concentration. Here, "Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.

C168 is the calculated blood concentration at 168 hours post-dose at which the measured blood concentration is at or above the Lower Limit of quantification (LLQ).

PK analysis set included all participants, who received one dose of M5717, have no clinically important protocol deviations or important events affecting PK, & provide at least one measurable post-dose concentration. "Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.

Time to reach the maximum blood concentration (Tmax) was obtained directly from the concentration versus time curve.

Pharmacokinetic analysis set included all participants, who received one dose of M5717, have no clinically important protocol deviations or important events affecting PK, and provide at least one measurable post-dose concentration.

Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by lambda z.

PK analysis set included all participants, who received 1 dose of M5717, had no clinically important protocol deviations/important events affecting PK, & provide at least 1 measurable post-dose concentration. Data was not available for 'Early liver stage: 30 mg M5717' arm as no participants were considered evaluable because of limited number of samples collected to characterize the elimination rate constant (lambda z) needed for calculation of t1/2.

Elimination rate constant determined from the terminal slope of the log-transformed concentration curve using linear regression on terminal data points of the curve.

PK analysis set included all participants, who received 1 dose of M5717, had no clinically important protocol deviations/important events affecting PK, & provide at least 1 measurable post-dose concentration. Data was not available for 'Early liver stage: 30 mg M5717' arm as no participants were considered evaluable because of limited number of samples collected to characterize the elimination rate constant (lambda z).

Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent body clearance of the drug from blood, CL= Dose/AUC0-inf

PK analysis set included all participants, who received 1 dose of M5717, had no clinically important protocol deviations/important events affecting PK, & provide at least 1 measurable post-dose concentration. Data was not available for 'Early liver stage: 30 mg M5717' arm as no participants were considered evaluable because of limited number of samples collected to characterize the elimination rate constant (lambda z) needed for calculation of CL/f.

The Vz/f was defined as the theoretical volume in which the total amount of required to uniformly distribute to produce the desired plasma concentration. Apparent volume of distribution after oral dose (Vz/F) was influenced by the fraction absorbed. The Vz/f was calculated by dividing the dose with area under the concentration time curve from time zero to infinity multiplied with terminal elimination rate constant Lambda(z). Vz/f=Dose/AUC(0-inf) multiply Lambda(z).

PK analysis set included all participants, who received 1 dose of M5717, had no clinically important protocol deviations/important events affecting PK, & provide at least 1 measurable post-dose concentration. Data was not available for 'Early liver stage: 30 mg M5717' arm as no participants were considered evaluable because of limited number of samples collected to characterize the elimination rate constant (lambda z) needed for calculation of Vz/F.

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.

PP analysis set included all SAF participants who comply with protocol and meet no criteria that could impact proper evaluation of key objectives of study. This data was analyzed together jointly across cohorts and hence model parameter were based on complete data set as opposed to cohort by cohort.