Trial Outcomes & Findings for MMV390048 POC in Patients With P. Vivax and P. Falciparum Malaria (NCT NCT02880241)

NCT ID: NCT02880241

Last Updated: 2021-12-09

Results Overview

The absence of parasitaemia (thick smear) on Day 14, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure, late clinical failure or late parasitological failure. Parasitaemia was defined as a P. vivax asexual forms count \>0

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 8 participants
• Primary outcome timeframe: On Day 14 post-dose
• Results posted on: 2021-12-09

Participant Flow

Participant milestones

Measure	Cohort 1A - P. Vivax Malaria A single oral dose of up to 120mg MMV390048 MMV390048: Tablets of 20mg each	Cohort 1B - P. Falciparum Malaria A single oral dose of up to 120mg MMV390048 MMV390048: Tablets of 20mg each	Cohort 2A - P. Vivax Malaria A single oral dose (to be determined) of MMV390048 MMV390048: Tablets of 20mg each	Cohort 2B - P. Falciparum Malaria A single oral dose (to be determined) of MMV390048 MMV390048: Tablets of 20mg each	Cohort 3A - P. Vivax Malaria A single oral dose (to be determined) of MMV390048 MMV390048: Tablets of 20mg each	Cohort 3B - P. Falciparum Malaria A single oral dose (to be determined) of MMV390048 MMV390048: Tablets of 20mg each
Overall Study STARTED	8	0	0	0	0	0
Overall Study COMPLETED	7	0	0	0	0	0
Overall Study NOT COMPLETED	1	0	0	0	0	0

Reasons for withdrawal

Measure	Cohort 1A - P. Vivax Malaria A single oral dose of up to 120mg MMV390048 MMV390048: Tablets of 20mg each	Cohort 1B - P. Falciparum Malaria A single oral dose of up to 120mg MMV390048 MMV390048: Tablets of 20mg each	Cohort 2A - P. Vivax Malaria A single oral dose (to be determined) of MMV390048 MMV390048: Tablets of 20mg each	Cohort 2B - P. Falciparum Malaria A single oral dose (to be determined) of MMV390048 MMV390048: Tablets of 20mg each	Cohort 3A - P. Vivax Malaria A single oral dose (to be determined) of MMV390048 MMV390048: Tablets of 20mg each	Cohort 3B - P. Falciparum Malaria A single oral dose (to be determined) of MMV390048 MMV390048: Tablets of 20mg each
Overall Study Lack of Efficacy	1	0	0	0	0	0

Baseline Characteristics

MMV390048 POC in Patients With P. Vivax and P. Falciparum Malaria

Baseline characteristics by cohort

Measure	Cohort 1A - P. Vivax Malaria n=8 Participants A single oral dose of up to 120mg MMV390048 MMV390048: Tablets of 20mg each	Cohort 1B - P. Falciparum Malaria A single oral dose of up to 120mg MMV390048 MMV390048: Tablets of 20mg each	Cohort 2A - P. Vivax Malaria A single oral dose (to be determined) of MMV390048 MMV390048: Tablets of 20mg each	Cohort 2B - P. Falciparum Malaria A single oral dose (to be determined) of MMV390048 MMV390048: Tablets of 20mg each	Cohort 3A - P. Vivax Malaria A single oral dose (to be determined) of MMV390048 MMV390048: Tablets of 20mg each	Cohort 3B - P. Falciparum Malaria A single oral dose (to be determined) of MMV390048 MMV390048: Tablets of 20mg each	Total n=8 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	—	—	—	—	—	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	—	—	—	—	—	8 Participants n=8 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	—	—	—	—	—	0 Participants n=8 Participants
Age, Continuous	24.5 Years n=5 Participants	—	—	—	—	—	24.5 Years n=8 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	—	—	—	—	—	0 Participants n=8 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	—	—	—	—	—	8 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	—	—	—	—	—	0 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants	—	—	—	—	—	8 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	—	—	—	—	—	0 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	—	—	—	—	—	0 Participants n=8 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	—	—	—	—	—	0 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	—	—	—	—	—	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants	—	—	—	—	—	8 Participants n=8 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	—	—	—	—	—	0 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	—	—	—	—	—	0 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	—	—	—	—	—	0 Participants n=8 Participants
Region of Enrollment Ethiopia	8 participants n=5 Participants	—	—	—	—	—	8 participants n=8 Participants
Pre-dose asexual parasite count	6405.5 asexual parasite/μL STANDARD_DEVIATION 6766.6 • n=5 Participants	—	—	—	—	—	6405.5 asexual parasite/μL STANDARD_DEVIATION 6766.6 • n=8 Participants
Body Mass Index	18.1 kg/m^2 STANDARD_DEVIATION 1.20 • n=5 Participants	—	—	—	—	—	18.1 kg/m^2 STANDARD_DEVIATION 1.20 • n=8 Participants
Pre-dose gametocyte count	268.5 gametocyte/μL STANDARD_DEVIATION 355.2 • n=5 Participants	—	—	—	—	—	268.5 gametocyte/μL STANDARD_DEVIATION 355.2 • n=8 Participants

PRIMARY outcome

Timeframe: On Day 14 post-dose

Population: All enrolled participants who received any amount of study medication.

The absence of parasitaemia (thick smear) on Day 14, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure, late clinical failure or late parasitological failure. Parasitaemia was defined as a P. vivax asexual forms count >0

Outcome measures

Measure	Cohort 1B - P. Falciparum Malaria A single oral dose of up to 120mg MMV390048 MMV390048: Tablets of 20mg each	Cohort 1A - P. Vivax Malaria n=8 Participants A single oral dose of up to 120mg MMV390048 MMV390048: Tablets of 20mg each	Cohort 2A - P. Vivax Malaria A single oral dose (to be determined) of MMV390048 MMV390048: Tablets of 20mg each	Cohort 2B - P. Falciparum Malaria A single oral dose (to be determined) of MMV390048 MMV390048: Tablets of 20mg each	Cohort 3A - P. Vivax Malaria A single oral dose (to be determined) of MMV390048 MMV390048: Tablets of 20mg each	Cohort 3B - P. Falciparum Malaria A single oral dose (to be determined) of MMV390048 MMV390048: Tablets of 20mg each
Number of Participants With Crude Adequate Clinical and Parasitological Response (ACPR) for P. Vivax	—	8 participants	—	—	—	—

PRIMARY outcome

Timeframe: On Day 14 post-dose

Population: Cohort 1B - P falciparum malaria did not enroll participants.

Number of participants meeting PCR-adjusted Crude Adequate Clinical and Parasitological Response (ACPR)

Outcome measures

Outcome data not reported

Adverse Events

Cohort 1B - P. Falciparum Malaria

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cohort 1A - P. Vivax Malaria

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Cohort 2A - P. Vivax Malaria

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cohort 2B - P. Falciparum Malaria

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cohort 3A - P. Vivax Malaria

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cohort 3B - P. Falciparum Malaria

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Cohort 1B - P. Falciparum Malaria A single oral dose of up to 120mg MMV390048 MMV390048: Tablets of 20mg each	Cohort 1A - P. Vivax Malaria n=8 participants at risk A single oral dose of up to 120mg MMV390048 MMV390048: Tablets of 20mg each	Cohort 2A - P. Vivax Malaria A single oral dose (to be determined) of MMV390048 MMV390048: Tablets of 20mg each	Cohort 2B - P. Falciparum Malaria A single oral dose (to be determined) of MMV390048 MMV390048: Tablets of 20mg each	Cohort 3A - P. Vivax Malaria A single oral dose (to be determined) of MMV390048 MMV390048: Tablets of 20mg each	Cohort 3B - P. Falciparum Malaria A single oral dose (to be determined) of MMV390048 MMV390048: Tablets of 20mg each
Gastrointestinal disorders Abdominal discomfort	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	25.0% 2/8 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.
Gastrointestinal disorders Abdominal pain	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	12.5% 1/8 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.
Gastrointestinal disorders Constipation	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	12.5% 1/8 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.
Gastrointestinal disorders Dyspepsia	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	12.5% 1/8 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.
Gastrointestinal disorders Nausea	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	12.5% 1/8 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.
Gastrointestinal disorders Oral discomfort	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	12.5% 1/8 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.
Gastrointestinal disorders Vomiting	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	12.5% 1/8 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.
Nervous system disorders Headache	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	25.0% 2/8 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.
Infections and infestations Ascariasis	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	12.5% 1/8 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.
Infections and infestations Carbuncle	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	12.5% 1/8 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.
Infections and infestations Hookworm infection	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	12.5% 1/8 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.
Infections and infestations P.falciparum infection	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	12.5% 1/8 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.
Infections and infestations Upper respiratory tract infection	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	12.5% 1/8 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.
Metabolism and nutrition disorders Decreased appetite	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	12.5% 1/8 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.
Blood and lymphatic system disorders Neutropenia	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	12.5% 1/8 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.
Cardiac disorders Sinus Tachycardia	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	12.5% 1/8 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.
General disorders Fatigue	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	12.5% 1/8 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.
Investigations Haemoglobin decreased	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	12.5% 1/8 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.
Musculoskeletal and connective tissue disorders Arthralgia	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	12.5% 1/8 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.
Renal and urinary disorders Urinary Tract Discomfort	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	12.5% 1/8 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.	— 0/0 • From IMP administration (Day 0) to End of Study (Day 35) SAEs will be recorded from the time of screening until the end of study, and additionally until 30 days after completion of the study should the Investigator be made aware of such an event.

Additional Information

Dr Stephan Duparc, Chief Medical Officer

Medicines for Malaria Venture (MMV)

Phone: +41 22 555 0351

Email: duparcs@mmv.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place