Trial Outcomes & Findings for Chemoprophylactic Activity of M5717 in PfSPZ Challenge Model (NCT NCT04250363)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

39 participants

Primary outcome timeframe

Early Liver Stage: From Day 1 up to Day 28

Results posted on

2024-05-01

Participant Flow

A total of 39 participants (27 participants in early liver stage group and 12 participants in late liver stage group) were enrolled and randomized for treatment at single site in Netherlands.

Participant milestones

Participant milestones
Measure	Early Liver Stage: Pooled Placebo 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 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 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 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 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 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 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 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 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 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.
Overall Study STARTED	6	3	6	6	3	3	3	3	3	3
Overall Study COMPLETED	6	3	6	6	3	3	3	3	3	3
Overall Study NOT COMPLETED	0	0	0	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Chemoprophylactic Activity of M5717 in PfSPZ Challenge Model

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Early Liver Stage: Pooled Placebo n=6 Participants 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 n=3 Participants 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 n=6 Participants 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 n=6 Participants 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 n=3 Participants 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 n=3 Participants 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 n=3 Participants 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 n=3 Participants 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 n=3 Participants 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 n=3 Participants 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.	Total n=39 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=10 Participants	3 Participants n=115 Participants	3 Participants n=24 Participants	3 Participants n=42 Participants	3 Participants n=42 Participants	39 Participants n=42 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	2 Participants n=115 Participants	1 Participants n=24 Participants	2 Participants n=42 Participants	1 Participants n=42 Participants	11 Participants n=42 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=10 Participants	1 Participants n=115 Participants	2 Participants n=24 Participants	1 Participants n=42 Participants	2 Participants n=42 Participants	28 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	6 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=10 Participants	3 Participants n=115 Participants	3 Participants n=24 Participants	3 Participants n=42 Participants	3 Participants n=42 Participants	38 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	0 Participants n=115 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	2 Participants n=42 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants	5 Participants n=4 Participants	3 Participants n=21 Participants	2 Participants n=10 Participants	3 Participants n=115 Participants	2 Participants n=24 Participants	3 Participants n=42 Participants	3 Participants n=42 Participants	35 Participants n=42 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants

PRIMARY outcome

Timeframe: Early Liver Stage: From Day 1 up to Day 28

Population: 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.

Outcome measures

Outcome measures
Measure	Early Liver Stage: Pooled Placebo n=6 Participants 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 n=3 Participants 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 n=6 Participants 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 n=6 Participants 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 n=3 Participants 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 n=3 Participants 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 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 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 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 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.
Early Liver Stage: Number of Participants Over Time With Positive Parasitemia	6 Participants	3 Participants	2 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—

PRIMARY outcome

Timeframe: Late Liver Stage: From Day 5 up to Day 32

Population: 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.

Outcome measures

Outcome measures
Measure	Early Liver Stage: Pooled Placebo n=3 Participants 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 n=3 Participants 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 n=3 Participants 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 n=3 Participants 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 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 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 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 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 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 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.
Late Liver Stage: Number of Participants Over Time With Positive Parasitemia	3 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Early Liver Stage: From Day 1 up to Day 28

Population: 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.

Outcome measures

Outcome measures
Measure	Early Liver Stage: Pooled Placebo n=6 Participants 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 n=3 Participants 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 n=2 Participants 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 n=1 Participants 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 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 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 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 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 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 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.
Early Liver Stage: Time to First Positive Parasitemia Based on Quantitative Polymerase Chain Reaction (qPCR)	10.0 Days Interval 9.0 to 12.0	15.0 Days Interval 15.0 to 18.0	22.0 Days Interval 20.0 to 24.0	24.0 Days Interval 24.0 to 24.0	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Late Liver Stage: From Day 5 up to Day 32

Population: 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.

Outcome measures

Outcome measures
Measure	Early Liver Stage: Pooled Placebo n=3 Participants 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 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 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 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 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 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 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 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 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 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.
Late Liver Stage: Time to First Positive Parasitemia Based on Quantitative Polymerase Chain Reaction (qPCR)	10.0 Days Interval 9.0 to 11.0	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Early Liver Stage: From Day 1 up to Day 28

Population: 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.

Outcome measures

Outcome measures
Measure	Early Liver Stage: Pooled Placebo n=6 Participants 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 n=3 Participants 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 n=6 Participants 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 n=6 Participants 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 n=3 Participants 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 n=3 Participants 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 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 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 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 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.
Early Liver Stage: Number of Participants With Documented Blood Stage Parasite Growth	5 Participants	2 Participants	2 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—

PRIMARY outcome

Timeframe: Late Liver Stage: From Day 5 up to Day 32

Population: 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.

Outcome measures

Outcome measures
Measure	Early Liver Stage: Pooled Placebo n=3 Participants 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 n=3 Participants 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 n=3 Participants 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 n=3 Participants 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 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 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 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 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 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 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.
Late Liver Stage: Number of Participants With Documented Blood Stage Parasite Growth	3 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Early Liver Stage: At Day 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 22, 24, 26 and 28

Population: 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.

Outcome measures

Outcome measures
Measure	Early Liver Stage: Pooled Placebo n=6 Participants 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 n=3 Participants 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 n=6 Participants 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 n=6 Participants 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 n=3 Participants 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 n=3 Participants 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 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 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 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 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.
Early Liver Stage: Clinical Symptoms of Malaria Assessed Using Malaria Clinical Score At Day 6	0.0 score on a Scale Standard Deviation 0.00	0.3 score on a Scale Standard Deviation 0.58	0.2 score on a Scale Standard Deviation 0.41	0.0 score on a Scale Standard Deviation 0.00	0.0 score on a Scale Standard Deviation 0.00	0.1 score on a Scale Standard Deviation 0.30	—	—	—	—
Early Liver Stage: Clinical Symptoms of Malaria Assessed Using Malaria Clinical Score At Day 7	0.3 score on a Scale Standard Deviation 0.52	0.3 score on a Scale Standard Deviation 0.58	0.0 score on a Scale Standard Deviation 0.00	0.0 score on a Scale Standard Deviation 0.00	0.0 score on a Scale Standard Deviation 0.00	0.0 score on a Scale Standard Deviation 0.00	—	—	—	—
Early Liver Stage: Clinical Symptoms of Malaria Assessed Using Malaria Clinical Score At Day 8	0.2 score on a Scale Standard Deviation 0.41	0.3 score on a Scale Standard Deviation 0.58	0.0 score on a Scale Standard Deviation 0.00	0.0 score on a Scale Standard Deviation 0.00	0.0 score on a Scale Standard Deviation 0.00	0.0 score on a Scale Standard Deviation 0.00	—	—	—	—
Early Liver Stage: Clinical Symptoms of Malaria Assessed Using Malaria Clinical Score At Day 9	0.2 score on a Scale Standard Deviation 0.41	0.3 score on a Scale Standard Deviation 0.58	0.2 score on a Scale Standard Deviation 0.41	0.0 score on a Scale Standard Deviation 0.00	0.0 score on a Scale Standard Deviation 0.00	0.0 score on a Scale Standard Deviation 0.00	—	—	—	—
Early Liver Stage: Clinical Symptoms of Malaria Assessed Using Malaria Clinical Score At Day 10	0.3 score on a Scale Standard Deviation 0.52	0.3 score on a Scale Standard Deviation 0.58	0.0 score on a Scale Standard Deviation 0.00	0.3 score on a Scale Standard Deviation 0.52	0.0 score on a Scale Standard Deviation 0.00	0.0 score on a Scale Standard Deviation 0.00	—	—	—	—
Early Liver Stage: Clinical Symptoms of Malaria Assessed Using Malaria Clinical Score At Day 11	0.2 score on a Scale Standard Deviation 0.41	0.0 score on a Scale Standard Deviation 0.00	0.0 score on a Scale Standard Deviation 0.00	0.2 score on a Scale Standard Deviation 0.41	0.0 score on a Scale Standard Deviation 0.00	0.0 score on a Scale Standard Deviation 0.00	—	—	—	—
Early Liver Stage: Clinical Symptoms of Malaria Assessed Using Malaria Clinical Score At Day 12	0.0 score on a Scale Standard Deviation 0.00	0.0 score on a Scale Standard Deviation 0.00	0.0 score on a Scale Standard Deviation 0.00	0.2 score on a Scale Standard Deviation 0.41	0.0 score on a Scale Standard Deviation 0.00	0.0 score on a Scale Standard Deviation 0.00	—	—	—	—
Early Liver Stage: Clinical Symptoms of Malaria Assessed Using Malaria Clinical Score At Day 13	1.7 score on a Scale Standard Deviation 1.86	0.0 score on a Scale Standard Deviation 0.00	0.0 score on a Scale Standard Deviation 0.00	0.0 score on a Scale Standard Deviation 0.00	0.0 score on a Scale Standard Deviation 0.00	0.0 score on a Scale Standard Deviation 0.00	—	—	—	—
Early Liver Stage: Clinical Symptoms of Malaria Assessed Using Malaria Clinical Score At Day 14	4.5 score on a Scale Standard Deviation 3.00	0.0 score on a Scale Standard Deviation 0.00	0.0 score on a Scale Standard Deviation 0.00	0.0 score on a Scale Standard Deviation 0.00	0.0 score on a Scale Standard Deviation 0.00	0.0 score on a Scale Standard Deviation 0.00	—	—	—	—
Early Liver Stage: Clinical Symptoms of Malaria Assessed Using Malaria Clinical Score At Day 15	1.5 score on a Scale Standard Deviation 2.07	0.0 score on a Scale Standard Deviation 0.00	0.2 score on a Scale Standard Deviation 0.41	0.2 score on a Scale Standard Deviation 0.41	0.0 score on a Scale Standard Deviation 0.00	0.0 score on a Scale Standard Deviation 0.00	—	—	—	—
Early Liver Stage: Clinical Symptoms of Malaria Assessed Using Malaria Clinical Score At Day 16	2.0 score on a Scale Standard Deviation 1.41	0.3 score on a Scale Standard Deviation 0.58	0.3 score on a Scale Standard Deviation 0.52	0.2 score on a Scale Standard Deviation 0.41	0.0 score on a Scale Standard Deviation 0.00	0.0 score on a Scale Standard Deviation 0.00	—	—	—	—
Early Liver Stage: Clinical Symptoms of Malaria Assessed Using Malaria Clinical Score At Day 17	0.5 score on a Scale Standard Deviation 0.71	2.0 score on a Scale Standard Deviation 3.46	0.3 score on a Scale Standard Deviation 0.52	0.2 score on a Scale Standard Deviation 0.41	0.0 score on a Scale Standard Deviation 0.00	0.0 score on a Scale Standard Deviation 0.00	—	—	—	—
Early Liver Stage: Clinical Symptoms of Malaria Assessed Using Malaria Clinical Score At Day 18	1.0 score on a Scale Standard Deviation 1.41	2.3 score on a Scale Standard Deviation 4.04	0.3 score on a Scale Standard Deviation 0.52	0.2 score on a Scale Standard Deviation 0.41	0.3 score on a Scale Standard Deviation 0.58	0.3 score on a Scale Standard Deviation 0.58	—	—	—	—
Early Liver Stage: Clinical Symptoms of Malaria Assessed Using Malaria Clinical Score At Day 19	—	0.7 score on a Scale Standard Deviation 1.15	0.3 score on a Scale Standard Deviation 0.52	0.0 score on a Scale Standard Deviation 0.00	0.3 score on a Scale Standard Deviation 0.58	0.0 score on a Scale Standard Deviation 0.00	—	—	—	—
Early Liver Stage: Clinical Symptoms of Malaria Assessed Using Malaria Clinical Score At Day 20	—	1.0 score on a Scale Standard Deviation 1.73	0.0 score on a Scale Standard Deviation 0.00	0.0 score on a Scale Standard Deviation 0.00	0.3 score on a Scale Standard Deviation 0.58	0.0 score on a Scale Standard Deviation 0.00	—	—	—	—
Early Liver Stage: Clinical Symptoms of Malaria Assessed Using Malaria Clinical Score At Day 22	0.0 score on a Scale Standard Deviation 0.00	0.7 score on a Scale Standard Deviation 1.15	0.0 score on a Scale Standard Deviation 0.00	0.2 score on a Scale Standard Deviation 0.41	0.0 score on a Scale Standard Deviation 0.00	0.0 score on a Scale Standard Deviation 0.00	—	—	—	—
Early Liver Stage: Clinical Symptoms of Malaria Assessed Using Malaria Clinical Score At Day 24	—	—	0.0 score on a Scale Standard Deviation 0.00	0.2 score on a Scale Standard Deviation 0.41	0.0 score on a Scale Standard Deviation 0.00	0.0 score on a Scale Standard Deviation 0.00	—	—	—	—
Early Liver Stage: Clinical Symptoms of Malaria Assessed Using Malaria Clinical Score At Day 26	0.0 score on a Scale Standard Deviation 0.00	0.0 score on a Scale Standard Deviation 0.00	0.2 score on a Scale Standard Deviation 0.41	0.2 score on a Scale Standard Deviation 0.41	0.0 score on a Scale Standard Deviation 0.00	0.3 score on a Scale Standard Deviation 0.58	—	—	—	—
Early Liver Stage: Clinical Symptoms of Malaria Assessed Using Malaria Clinical Score At Day 28	0.0 score on a Scale Standard Deviation 0.0	0.0 score on a Scale Standard Deviation 0.00	0.2 score on a Scale Standard Deviation 0.41	0.2 score on a Scale Standard Deviation 0.41	0.3 score on a Scale Standard Deviation 0.58	0.0 score on a Scale Standard Deviation 0.00	—	—	—	—

PRIMARY outcome

Timeframe: Late Liver Stage: At Day 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 26, 28, 30 and 32

Population: 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.

Outcome measures

Outcome measures
Measure	Early Liver Stage: Pooled Placebo n=3 Participants 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 n=3 Participants 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 n=3 Participants 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 n=3 Participants 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 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 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 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 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 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 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.
Late Liver Stage: Clinical Symptoms of Malaria Assessed Using Malaria Clinical Score At Day 6	0.0 Score on a Scale Standard Deviation 0.00	0.0 Score on a Scale Standard Deviation 0.00	0.0 Score on a Scale Standard Deviation 0.00	0.0 Score on a Scale Standard Deviation 0.00	—	—	—	—	—	—
Late Liver Stage: Clinical Symptoms of Malaria Assessed Using Malaria Clinical Score At Day 7	0.0 Score on a Scale Standard Deviation 0.00	0.3 Score on a Scale Standard Deviation 0.58	0.0 Score on a Scale Standard Deviation 0.00	0.0 Score on a Scale Standard Deviation 0.00	—	—	—	—	—	—
Late Liver Stage: Clinical Symptoms of Malaria Assessed Using Malaria Clinical Score At Day 8	0.0 Score on a Scale Standard Deviation 0.00	0.0 Score on a Scale Standard Deviation 0.00	0.3 Score on a Scale Standard Deviation 0.58	0.0 Score on a Scale Standard Deviation 0.00	—	—	—	—	—	—
Late Liver Stage: Clinical Symptoms of Malaria Assessed Using Malaria Clinical Score At Day 9	0.3 Score on a Scale Standard Deviation 0.58	0.0 Score on a Scale Standard Deviation 0.00	0.3 Score on a Scale Standard Deviation 0.58	0.0 Score on a Scale Standard Deviation 0.00	—	—	—	—	—	—
Late Liver Stage: Clinical Symptoms of Malaria Assessed Using Malaria Clinical Score At Day 10	0.3 Score on a Scale Standard Deviation 0.58	0.0 Score on a Scale Standard Deviation 0.00	0.0 Score on a Scale Standard Deviation 0.00	0.0 Score on a Scale Standard Deviation 0.00	—	—	—	—	—	—
Late Liver Stage: Clinical Symptoms of Malaria Assessed Using Malaria Clinical Score At Day 11	0.0 Score on a Scale Standard Deviation 0.00	0.0 Score on a Scale Standard Deviation 0.00	0.0 Score on a Scale Standard Deviation 0.00	0.0 Score on a Scale Standard Deviation 0.00	—	—	—	—	—	—
Late Liver Stage: Clinical Symptoms of Malaria Assessed Using Malaria Clinical Score At Day 12	0.0 Score on a Scale Standard Deviation 0.00	0.0 Score on a Scale Standard Deviation 0.00	0.0 Score on a Scale Standard Deviation 0.00	0.0 Score on a Scale Standard Deviation 0.00	—	—	—	—	—	—
Late Liver Stage: Clinical Symptoms of Malaria Assessed Using Malaria Clinical Score At Day 13	0.0 Score on a Scale Standard Deviation 0.00	0.3 Score on a Scale Standard Deviation 0.58	0.0 Score on a Scale Standard Deviation 0.00	0.0 Score on a Scale Standard Deviation 0.00	—	—	—	—	—	—
Late Liver Stage: Clinical Symptoms of Malaria Assessed Using Malaria Clinical Score At Day 14	0.0 Score on a Scale Standard Deviation 0.00	0.0 Score on a Scale Standard Deviation 0.00	0.3 Score on a Scale Standard Deviation 0.58	0.0 Score on a Scale Standard Deviation 0.00	—	—	—	—	—	—
Late Liver Stage: Clinical Symptoms of Malaria Assessed Using Malaria Clinical Score At Day 15	1.5 Score on a Scale Standard Deviation 2.12	0.0 Score on a Scale Standard Deviation 0.00	0.3 Score on a Scale Standard Deviation 0.58	0.3 Score on a Scale Standard Deviation 0.58	—	—	—	—	—	—
Late Liver Stage: Clinical Symptoms of Malaria Assessed Using Malaria Clinical Score At Day 16	1.5 Score on a Scale Standard Deviation 2.12	0.3 Score on a Scale Standard Deviation 0.58	0.0 Score on a Scale Standard Deviation 0.00	0.0 Score on a Scale Standard Deviation 0.00	—	—	—	—	—	—
Late Liver Stage: Clinical Symptoms of Malaria Assessed Using Malaria Clinical Score At Day 17	1.0 Score on a Scale	0.0 Score on a Scale Standard Deviation 0.00	0.3 Score on a Scale Standard Deviation 0.58	0.7 Score on a Scale Standard Deviation 1.15	—	—	—	—	—	—
Late Liver Stage: Clinical Symptoms of Malaria Assessed Using Malaria Clinical Score At Day 18	—	0.3 Score on a Scale Standard Deviation 0.58	0.3 Score on a Scale Standard Deviation 0.58	0.0 Score on a Scale Standard Deviation 0.00	—	—	—	—	—	—
Late Liver Stage: Clinical Symptoms of Malaria Assessed Using Malaria Clinical Score At Day 19	0.0 Score on a Scale Standard Deviation 0.00	0.0 Score on a Scale Standard Deviation 0.00	0.3 Score on a Scale Standard Deviation 0.58	0.0 Score on a Scale Standard Deviation 0.00	—	—	—	—	—	—
Late Liver Stage: Clinical Symptoms of Malaria Assessed Using Malaria Clinical Score At Day 20	—	0.0 Score on a Scale Standard Deviation 0.00	0.3 Score on a Scale Standard Deviation 0.58	0.0 Score on a Scale Standard Deviation 0.00	—	—	—	—	—	—
Late Liver Stage: Clinical Symptoms of Malaria Assessed Using Malaria Clinical Score At Day 21	—	0.3 Score on a Scale Standard Deviation 0.58	0.3 Score on a Scale Standard Deviation 0.58	0.3 Score on a Scale Standard Deviation 0.58	—	—	—	—	—	—
Late Liver Stage: Clinical Symptoms of Malaria Assessed Using Malaria Clinical Score At Day 22	—	0.0 Score on a Scale Standard Deviation 0.00	0.3 Score on a Scale Standard Deviation 0.58	0.3 Score on a Scale Standard Deviation 0.58	—	—	—	—	—	—
Late Liver Stage: Clinical Symptoms of Malaria Assessed Using Malaria Clinical Score At Day 23	—	0.0 Score on a Scale Standard Deviation 0.00	0.0 Score on a Scale Standard Deviation 0.00	0.3 Score on a Scale Standard Deviation 0.58	—	—	—	—	—	—
Late Liver Stage: Clinical Symptoms of Malaria Assessed Using Malaria Clinical Score At Day 24	—	0.0 Score on a Scale Standard Deviation 0.00	0.0 Score on a Scale Standard Deviation 0.00	0.0 Score on a Scale Standard Deviation 0.00	—	—	—	—	—	—
Late Liver Stage: Clinical Symptoms of Malaria Assessed Using Malaria Clinical Score At Day 26	0.3 Score on a Scale Standard Deviation 0.58	0.3 Score on a Scale Standard Deviation 0.58	0.0 Score on a Scale Standard Deviation 0.00	0.0 Score on a Scale Standard Deviation 0.00	—	—	—	—	—	—
Late Liver Stage: Clinical Symptoms of Malaria Assessed Using Malaria Clinical Score At Day 28	—	0.0 Score on a Scale Standard Deviation 0.00	0.0 Score on a Scale Standard Deviation 0.00	0.0 Score on a Scale Standard Deviation 0.00	—	—	—	—	—	—
Late Liver Stage: Clinical Symptoms of Malaria Assessed Using Malaria Clinical Score At Day 30	0.0 Score on a Scale Standard Deviation 0.00	0.0 Score on a Scale Standard Deviation 0.00	0.0 Score on a Scale Standard Deviation 0.00	0.00 Score on a Scale Standard Deviation 0.00	—	—	—	—	—	—
Late Liver Stage: Clinical Symptoms of Malaria Assessed Using Malaria Clinical Score At Day 32	0.0 Score on a Scale Standard Deviation 0.00	0.0 Score on a Scale Standard Deviation 0.00	0.0 Score on a Scale Standard Deviation 0.00	0.0 Score on a Scale Standard Deviation 0.00	—	—	—	—	—	—

PRIMARY outcome

Timeframe: From Day 5 up to Day 32

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Early Liver Stage: Pooled Placebo n=39 Participants 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 n=39 Participants 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 n=39 Participants 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 n=39 Participants 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 n=39 Participants 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 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 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 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 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 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.
Dose Exposure Response Relationship of M5717 Assessed by Logistic Regression Model	1.27 slope	1.43 slope	1.44 slope	0.800 slope	2.45 slope	—	—	—	—	—

SECONDARY outcome

Timeframe: Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36

Population: 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).

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.

Outcome measures

Outcome measures
Measure	Early Liver Stage: Pooled Placebo n=6 Participants 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 n=3 Participants 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 n=6 Participants 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 n=6 Participants 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 n=3 Participants 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 n=3 Participants 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 n=3 Participants 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 n=3 Participants 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 n=3 Participants 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 n=3 Participants 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.
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and Treatment-related TEAEs Participants with TEAEs	5 Participants	3 Participants	6 Participants	6 Participants	3 Participants	3 Participants	3 Participants	3 Participants	2 Participants	2 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and Treatment-related TEAEs Participants with Serious TEAEs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and Treatment-related TEAEs Participants with Treatment-related TEAEs	2 Participants	0 Participants	2 Participants	2 Participants	1 Participants	3 Participants	0 Participants	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36

Population: 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.

Outcome measures

Outcome measures
Measure	Early Liver Stage: Pooled Placebo n=6 Participants 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 n=3 Participants 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 n=6 Participants 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 n=6 Participants 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 n=3 Participants 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 n=3 Participants 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 n=3 Participants 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 n=3 Participants 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 n=3 Participants 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 n=3 Participants 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.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Based on Severity Grade 2 (Moderate)	3 Participants	2 Participants	2 Participants	1 Participants	0 Participants	1 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Based on Severity Grade 1 (Mild)	5 Participants	3 Participants	6 Participants	6 Participants	3 Participants	3 Participants	3 Participants	3 Participants	2 Participants	2 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Based on Severity Grade 3 (Severe)	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36

Population: 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).

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.

Outcome measures

Outcome measures
Measure	Early Liver Stage: Pooled Placebo n=6 Participants 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 n=3 Participants 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 n=6 Participants 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 n=6 Participants 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 n=3 Participants 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 n=3 Participants 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 n=3 Participants 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 n=3 Participants 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 n=3 Participants 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 n=3 Participants 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.
Number of Participants With Clinically Significant Change From Baseline in Laboratory Values	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36

Population: 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.

Outcome measures

Outcome measures
Measure	Early Liver Stage: Pooled Placebo n=6 Participants 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 n=3 Participants 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 n=6 Participants 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 n=6 Participants 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 n=3 Participants 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 n=3 Participants 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 n=3 Participants 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 n=3 Participants 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 n=3 Participants 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 n=3 Participants 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.
Number of Participants With Clinically Significant Change From Baseline in Vital Signs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36

Population: 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.

Outcome measures

Outcome measures
Measure	Early Liver Stage: Pooled Placebo n=6 Participants 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 n=3 Participants 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 n=6 Participants 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 n=6 Participants 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 n=3 Participants 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 n=3 Participants 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 n=3 Participants 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 n=3 Participants 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 n=3 Participants 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 n=3 Participants 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.
Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG) Findings	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 120, 168, 192, 600, and 768 hours post-dose

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Early Liver Stage: Pooled Placebo 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 n=6 Participants 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 n=6 Participants 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 n=3 Participants 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 n=3 Participants 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 n=3 Participants 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 n=3 Participants 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 n=3 Participants 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 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 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.
Area Under the Blood Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of M5717	—	1280 hournanogram per milliliter(hourng/mL) Geometric Coefficient of Variation 31.81	1990 hournanogram per milliliter(hourng/mL) Geometric Coefficient of Variation 25.24	1890 hournanogram per milliliter(hourng/mL) Geometric Coefficient of Variation 12.52	9840 hournanogram per milliliter(hourng/mL) Geometric Coefficient of Variation 37.44	1100 hournanogram per milliliter(hourng/mL) Geometric Coefficient of Variation 71.03	2330 hournanogram per milliliter(hourng/mL) Geometric Coefficient of Variation 4.70	4830 hournanogram per milliliter(hourng/mL) Geometric Coefficient of Variation 53.73	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 120, 168, 192, 600, and 768 hours post-dose

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Early Liver Stage: Pooled Placebo n=3 Participants 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 n=6 Participants 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 n=6 Participants 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 n=3 Participants 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 n=3 Participants 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 n=3 Participants 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 n=3 Participants 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 n=3 Participants 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 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 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.
Area Under the Blood Concentration-Time Curve From Time Zero to the Last Sampling Time (AUC 0-tlast) of M5717	21.9 hour*ng/mL Geometric Coefficient of Variation 1160.32	852 hour*ng/mL Geometric Coefficient of Variation 36.35	1270 hour*ng/mL Geometric Coefficient of Variation 14.08	1470 hour*ng/mL Geometric Coefficient of Variation 4.65	7330 hour*ng/mL Geometric Coefficient of Variation 42.80	657 hour*ng/mL Geometric Coefficient of Variation 67.17	1810 hour*ng/mL Geometric Coefficient of Variation 8.09	3820 hour*ng/mL Geometric Coefficient of Variation 70.38	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0.5, 1, 2, 3, 6, 12 and 24 hours post-dose

Population: 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.

Outcome measures

Outcome measures
Measure	Early Liver Stage: Pooled Placebo n=3 Participants 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 n=6 Participants 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 n=6 Participants 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 n=3 Participants 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 n=3 Participants 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 n=3 Participants 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 n=3 Participants 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 n=3 Participants 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 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 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.
Area Under the Blood Concentration-Time Curve From Time Zero to 24 Hours Post-dose (AUC 0-24) of M5717	25.8 h*ng/mL Geometric Coefficient of Variation 639.59	198 h*ng/mL Geometric Coefficient of Variation 40.21	280 h*ng/mL Geometric Coefficient of Variation 18.23	290 h*ng/mL Geometric Coefficient of Variation 39.80	975 h*ng/mL Geometric Coefficient of Variation 33.02	160 h*ng/mL Geometric Coefficient of Variation 44.63	445 h*ng/mL Geometric Coefficient of Variation 8.60	1020 h*ng/mL Geometric Coefficient of Variation 45.85	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 120 and 168 hours post-dose

Population: 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.

Outcome measures

Outcome measures
Measure	Early Liver Stage: Pooled Placebo n=3 Participants 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 n=6 Participants 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 n=6 Participants 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 n=3 Participants 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 n=3 Participants 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 n=3 Participants 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 n=3 Participants 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 n=3 Participants 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 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 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.
Area Under the Blood Concentration-Time Curve From Time Zero to 168 Hours Post-dose (AUC 0-168) of M5717	50.4 h*ng/mL Geometric Coefficient of Variation 2325.31	805 h*ng/mL Geometric Coefficient of Variation 35.22	1190 h*ng/mL Geometric Coefficient of Variation 14.35	1390 h*ng/mL Geometric Coefficient of Variation 5.34	3680 h*ng/mL Geometric Coefficient of Variation 29.33	692 h*ng/mL Geometric Coefficient of Variation 53.24	1710 h*ng/mL Geometric Coefficient of Variation 8.67	3190 h*ng/mL Geometric Coefficient of Variation 43.40	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 120, 168, 192, 600, and 768 hours post-dose

Population: 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.

Outcome measures

Outcome measures
Measure	Early Liver Stage: Pooled Placebo n=3 Participants 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 n=6 Participants 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 n=6 Participants 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 n=3 Participants 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 n=3 Participants 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 n=3 Participants 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 n=3 Participants 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 n=3 Participants 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 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 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.
Maximum Observed Blood Concentration (Cmax) of M5717	3.56 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 39.90	11.7 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 36.93	16.6 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 33.70	17.2 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 44.12	57.2 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 38.08	9.38 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 82.50	27.6 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 22.19	64.4 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 46.26	—	—

SECONDARY outcome

Timeframe: At 24 hours post-dose

Population: 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.

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

Outcome measures

Outcome measures
Measure	Early Liver Stage: Pooled Placebo n=2 Participants 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 n=6 Participants 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 n=6 Participants 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 n=3 Participants 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 n=3 Participants 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 n=3 Participants 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 n=3 Participants 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 n=3 Participants 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 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 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.
Blood Concentration at 24 Hours (C24) of M5717	NA ng/mL Geometric Coefficient of Variation NA Based on pre-specified criteria Geometric Mean and Geometric Coefficient of Variation were not calculated if fewer than 3 participants have reportable parameter values.	6.77 ng/mL Geometric Coefficient of Variation 45.35	9.42 ng/mL Geometric Coefficient of Variation 28.12	11.3 ng/mL Geometric Coefficient of Variation 31.42	30.6 ng/mL Geometric Coefficient of Variation 24.91	6.06 ng/mL Geometric Coefficient of Variation 37.89	14.9 ng/mL Geometric Coefficient of Variation 14.56	26.7 ng/mL Geometric Coefficient of Variation 37.88	—	—

SECONDARY outcome

Timeframe: At 168 hours post-dose

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Early Liver Stage: Pooled Placebo n=3 Participants 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 n=6 Participants 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 n=6 Participants 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 n=3 Participants 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 n=3 Participants 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 n=1 Participants 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 n=3 Participants 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 n=3 Participants 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 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 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.
Blood Concentration at 168 Hours (C168) of M5717	NA ng/mL Geometric Coefficient of Variation NA Data was not calculable as the concentration was at below the lower limit of quantification.	2.89 ng/mL Geometric Coefficient of Variation 38.61	4.31 ng/mL Geometric Coefficient of Variation 13.43	4.16 ng/mL Geometric Coefficient of Variation 24.60	11.4 ng/mL Geometric Coefficient of Variation 40.64	NA ng/mL Geometric Coefficient of Variation NA Based on pre-specified criteria Geometric Mean and Geometric Coefficient of Variation were not calculated if fewer than 3 participants have reportable parameter values.	4.88 ng/mL Geometric Coefficient of Variation 2.50	8.30 ng/mL Geometric Coefficient of Variation 45.60	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 120, 168, 192, 600, and 768 hours post-dose

Population: 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.

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

Outcome measures

Outcome measures
Measure	Early Liver Stage: Pooled Placebo n=3 Participants 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 n=6 Participants 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 n=6 Participants 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 n=3 Participants 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 n=3 Participants 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 n=3 Participants 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 n=3 Participants 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 n=3 Participants 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 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 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.
Time to Reach Maximum Blood Concentration (Tmax) of M5717	6.00 Hours Interval 0.5 to 12.0	1.00 Hours Interval 0.5 to 12.0	3.25 Hours Interval 0.5 to 12.0	6.00 Hours Interval 0.5 to 12.0	1.00 Hours Interval 0.5 to 6.0	1.00 Hours Interval 0.5 to 1.0	2.00 Hours Interval 1.0 to 2.02	2.00 Hours Interval 2.0 to 2.0	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 120, 168, 192, 600, and 768 hours post-dose

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Early Liver Stage: Pooled Placebo 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 n=6 Participants 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 n=6 Participants 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 n=3 Participants 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 n=3 Participants 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 n=3 Participants 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 n=3 Participants 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 n=3 Participants 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 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 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.
Apparent Terminal Half-life (t1/2) of M5717	—	121 Hours Interval 82.3 to 143.0	121 Hours Interval 97.2 to 221.0	66.9 Hours Interval 66.6 to 108.0	494 Hours Interval 212.0 to 531.0	94.1 Hours Interval 74.2 to 156.0	95.4 Hours Interval 76.0 to 95.5	136 Hours Interval 101.0 to 183.0	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 120, 168, 192, 600, and 768 hours post-dose

Population: 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).

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

Outcome measures

Outcome measures
Measure	Early Liver Stage: Pooled Placebo 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 n=6 Participants 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 n=6 Participants 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 n=3 Participants 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 n=3 Participants 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 n=3 Participants 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 n=3 Participants 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 n=3 Participants 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 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 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.
Elimination Rate Constant (Lambda z) of M5717	—	0.00597 One per Hours (1/h) Geometric Coefficient of Variation 22.93	0.00529 One per Hours (1/h) Geometric Coefficient of Variation 30.44	0.00885 One per Hours (1/h) Geometric Coefficient of Variation 28.59	0.00182 One per Hours (1/h) Geometric Coefficient of Variation 55.45	0.00677 One per Hours (1/h) Geometric Coefficient of Variation 38.43	0.00786 One per Hours (1/h) Geometric Coefficient of Variation 12.78	0.00511 One per Hours (1/h) Geometric Coefficient of Variation 30.50	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 120, 168, 192, 600, and 768 hours post-dose

Population: 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.

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

Outcome measures

Outcome measures
Measure	Early Liver Stage: Pooled Placebo 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 n=6 Participants 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 n=6 Participants 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 n=3 Participants 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 n=3 Participants 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 n=3 Participants 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 n=3 Participants 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 n=3 Participants 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 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 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.
Apparent Total Body Clearance From Blood (CL/f) of M5717	—	46.9 Liter per Hours (L/h) Geometric Coefficient of Variation 31.81	40.3 Liter per Hours (L/h) Geometric Coefficient of Variation 25.24	52.9 Liter per Hours (L/h) Geometric Coefficient of Variation 12.52	20.3 Liter per Hours (L/h) Geometric Coefficient of Variation 37.44	54.8 Liter per Hours (L/h) Geometric Coefficient of Variation 71.03	43.0 Liter per Hours (L/h) Geometric Coefficient of Variation 4.70	41.4 Liter per Hours (L/h) Geometric Coefficient of Variation 53.73	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 120, 168, 192, 600, and 768 hours post-dose

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Early Liver Stage: Pooled Placebo 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 n=6 Participants 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 n=6 Participants 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 n=3 Participants 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 n=3 Participants 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 n=3 Participants 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 n=3 Participants 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 n=3 Participants 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 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 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.
Apparent Volume of Distribution (Vz/F) During the Terminal Phase of M5717	—	7850 Liter Geometric Coefficient of Variation 42.71	7600 Liter Geometric Coefficient of Variation 10.87	5980 Liter Geometric Coefficient of Variation 15.57	11200 Liter Geometric Coefficient of Variation 60.47	8130 Liter Geometric Coefficient of Variation 35.29	5490 Liter Geometric Coefficient of Variation 15.71	27.59 Liter Geometric Coefficient of Variation 8340	—	—

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Early Liver Stage: Pooled Placebo n=6 participants at risk 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 n=3 participants at risk 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 n=6 participants at risk 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 n=6 participants at risk 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 n=3 participants at risk 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 n=3 participants at risk 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 n=3 participants at risk 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 n=3 participants at risk 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 n=3 participants at risk 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 n=3 participants at risk 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.
Gastrointestinal disorders Abdominal discomfort	33.3% 2/6 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	16.7% 1/6 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	16.7% 1/6 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	33.3% 1/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	33.3% 1/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36
Gastrointestinal disorders Abdominal distension	16.7% 1/6 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	33.3% 1/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/6 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/6 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	33.3% 1/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	33.3% 1/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	33.3% 1/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36
Gastrointestinal disorders Abdominal pain	0.00% 0/6 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/6 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	16.7% 1/6 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	33.3% 1/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36
Gastrointestinal disorders Aphthous ulcer	0.00% 0/6 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/6 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	16.7% 1/6 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36
Gastrointestinal disorders Diarrhoea	33.3% 2/6 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	16.7% 1/6 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	33.3% 2/6 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	100.0% 3/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	66.7% 2/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	66.7% 2/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	33.3% 1/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	33.3% 1/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36
Gastrointestinal disorders Nausea	66.7% 4/6 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	66.7% 4/6 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	16.7% 1/6 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	66.7% 2/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	33.3% 1/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	100.0% 3/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	66.7% 2/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	33.3% 1/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	66.7% 2/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36
Gastrointestinal disorders Tooth loss	0.00% 0/6 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	16.7% 1/6 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/6 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36
Gastrointestinal disorders Vomiting	16.7% 1/6 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/6 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/6 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	33.3% 1/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36
Nervous system disorders Dizziness	50.0% 3/6 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	16.7% 1/6 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/6 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	33.3% 1/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36
Nervous system disorders Headache	66.7% 4/6 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	66.7% 2/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	50.0% 3/6 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	50.0% 3/6 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	66.7% 2/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	66.7% 2/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	66.7% 2/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	33.3% 1/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	33.3% 1/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36
Nervous system disorders Paraesthesia	0.00% 0/6 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/6 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/6 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	33.3% 1/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36
Musculoskeletal and connective tissue disorders Myalgia	50.0% 3/6 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	100.0% 3/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	66.7% 4/6 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	50.0% 3/6 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	33.3% 1/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	33.3% 1/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	66.7% 2/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	33.3% 1/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	33.3% 1/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36
General disorders Chest pain	0.00% 0/6 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/6 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	16.7% 1/6 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36
General disorders Chills	33.3% 2/6 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	33.3% 1/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	33.3% 2/6 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/6 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36
General disorders Fatigue	50.0% 3/6 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	66.7% 2/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	16.7% 1/6 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/6 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	33.3% 1/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	33.3% 1/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	100.0% 3/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	33.3% 1/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36
General disorders Feeling cold	0.00% 0/6 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/6 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	16.7% 1/6 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36
General disorders Feeling hot	16.7% 1/6 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/6 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/6 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	33.3% 1/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36
General disorders Malaise	33.3% 2/6 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	33.3% 1/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/6 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	16.7% 1/6 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36
General disorders Pyrexia	33.3% 2/6 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	33.3% 1/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/6 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	16.7% 1/6 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	33.3% 1/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36
General disorders Tenderness	0.00% 0/6 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/6 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/6 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	33.3% 1/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36	0.00% 0/3 • Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36

Additional Information

Communication Center

Merck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Phone: +49-6151-72-5200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place