Trial Outcomes & Findings for Phase 1b MMV367 PK/PD and Safety in Healthy Adult Volunteers Experimentally Infected With Blood Stage P. Falciparum (NCT NCT05979207)
NCT ID: NCT05979207
Last Updated: 2025-12-10
Results Overview
Maximum effect of drug (maximum parasite killing rate). Emax used in the PK/PD model comes from the mean viable parasite elimination half-life of cohort 1 as estimated in the parasite viability report as Emax was not clearly observed in the cohort 2 parasitemia profiles.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
12 participants
Primary outcome timeframe
Day 8 (IMP dosing) until Day 27 (End of Study)
Results posted on
2025-12-10
Participant Flow
The protocol allowed for up to 18 participants, that is 3 cohorts of 6 participants, to be enrolled. Between each cohort there was a review of the safety and PK/PD modelling data, before progressing to the next cohort. The review of safety and PK/PD data after cohort 2 determined there was sufficient data to meet the study objective and a third cohort was not required.
Participant milestones
| Measure |
Cohort 1: MMV367 20mg
IBSM challenge and MMV367
P. falciparum IBSM infection: Induced Blood Stage Malaria from infected erythrocytes.
MMV367 20mg: Single dose
|
Cohort 1: MMV367 90mg
IBSM challenge and MMV367
P. falciparum IBSM infection: Induced Blood Stage Malaria from infected erythrocytes.
MMV367 90mg: Single dose
|
Cohort 1: MMV367 1500mg
IBSM challenge and MMV367
P. falciparum IBSM infection: Induced Blood Stage Malaria from infected erythrocytes.
MMV367 1500mg: Single dose
|
Cohort 2: MMV367 3mg
IBSM challenge and MMV367
MMV367 3mg: Single dose
P. falciparum IBSM infection: Induced Blood Stage Malaria from infected erythrocytes.
|
Cohort 2: MMV367 5mg
IBSM challenge and MMV367
P. falciparum IBSM infection: Induced Blood Stage Malaria from infected erythrocytes.
MMV367 5mg: Single dose
|
Cohort 2: MMV367 10mg
IBSM challenge and MMV367
P. falciparum IBSM infection: Induced Blood Stage Malaria from infected erythrocytes.
MMV367 10mg: Single dose
|
|---|---|---|---|---|---|---|
|
Initial Randomization and PKPD Modelling
STARTED
|
3
|
2
|
1
|
0
|
0
|
0
|
|
Initial Randomization and PKPD Modelling
COMPLETED
|
3
|
2
|
1
|
0
|
0
|
0
|
|
Initial Randomization and PKPD Modelling
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Cohort 2 Dosing and Modelling
STARTED
|
0
|
0
|
0
|
3
|
2
|
1
|
|
Cohort 2 Dosing and Modelling
COMPLETED
|
0
|
0
|
0
|
3
|
2
|
1
|
|
Cohort 2 Dosing and Modelling
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 1b MMV367 PK/PD and Safety in Healthy Adult Volunteers Experimentally Infected With Blood Stage P. Falciparum
Baseline characteristics by cohort
| Measure |
MMV367 20mg
n=3 Participants
IBSM challenge and MMV367
P. falciparum IBSM infection: Induced Blood Stage Malaria from infected erythrocytes.
MMV367 20mg: Single dose
|
MMV367 90mg
n=2 Participants
IBSM challenge and MMV367
P. falciparum IBSM infection: Induced Blood Stage Malaria from infected erythrocytes.
MMV367 90mg: Single dose
|
MMV367 1500mg
n=1 Participants
IBSM challenge and MMV367
P. falciparum IBSM infection: Induced Blood Stage Malaria from infected erythrocytes.
MMV367 1500mg: Single dose
|
Total
n=12 Participants
Total of all reporting groups
|
MMV367 3mg
n=3 Participants
IBSM challenge and MMV367
MMV367 3mg: Single dose
P. falciparum IBSM infection: Induced Blood Stage Malaria from infected erythrocytes.
|
MMV367 5mg
n=2 Participants
IBSM challenge and MMV367
P. falciparum IBSM infection: Induced Blood Stage Malaria from infected erythrocytes.
MMV367 5mg: Single dose
|
MMV367 10mg
n=1 Participants
IBSM challenge and MMV367
P. falciparum IBSM infection: Induced Blood Stage Malaria from infected erythrocytes.
MMV367 10mg: Single dose
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
23.7 years
STANDARD_DEVIATION 6.43 • n=639 Participants
|
38.0 years
STANDARD_DEVIATION 12.73 • n=277 Participants
|
35.0 years
STANDARD_DEVIATION 0 • n=294 Participants
|
29.0 years
STANDARD_DEVIATION 10.53 • n=3238 Participants
|
20.0 years
STANDARD_DEVIATION 2.00 • n=4 Participants
|
36.5 years
STANDARD_DEVIATION 17.68 • n=50 Participants
|
33.0 years
STANDARD_DEVIATION 0 • n=681 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=639 Participants
|
0 Participants
n=277 Participants
|
1 Participants
n=294 Participants
|
6 Participants
n=3238 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=50 Participants
|
0 Participants
n=681 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=639 Participants
|
2 Participants
n=277 Participants
|
0 Participants
n=294 Participants
|
6 Participants
n=3238 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=50 Participants
|
1 Participants
n=681 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=639 Participants
|
0 Participants
n=277 Participants
|
0 Participants
n=294 Participants
|
0 Participants
n=3238 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=681 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=639 Participants
|
2 Participants
n=277 Participants
|
1 Participants
n=294 Participants
|
12 Participants
n=3238 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=50 Participants
|
1 Participants
n=681 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=639 Participants
|
0 Participants
n=277 Participants
|
0 Participants
n=294 Participants
|
0 Participants
n=3238 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=681 Participants
|
|
Race/Ethnicity, Customized
White
|
2 Participants
n=639 Participants
|
2 Participants
n=277 Participants
|
1 Participants
n=294 Participants
|
10 Participants
n=3238 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=50 Participants
|
1 Participants
n=681 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=639 Participants
|
0 Participants
n=277 Participants
|
0 Participants
n=294 Participants
|
1 Participants
n=3238 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=50 Participants
|
0 Participants
n=681 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
1 Participants
n=639 Participants
|
0 Participants
n=277 Participants
|
0 Participants
n=294 Participants
|
4 Participants
n=3238 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=50 Participants
|
1 Participants
n=681 Participants
|
|
Region of Enrollment
Australia
|
3 participants
n=639 Participants
|
2 participants
n=277 Participants
|
1 participants
n=294 Participants
|
12 participants
n=3238 Participants
|
3 participants
n=4 Participants
|
2 participants
n=50 Participants
|
1 participants
n=681 Participants
|
PRIMARY outcome
Timeframe: Day 8 (IMP dosing) until Day 27 (End of Study)Population: The model-derived primary outcome Emax is estimated from all reporting groups of cohort 1 and 2.
Maximum effect of drug (maximum parasite killing rate). Emax used in the PK/PD model comes from the mean viable parasite elimination half-life of cohort 1 as estimated in the parasite viability report as Emax was not clearly observed in the cohort 2 parasitemia profiles.
Outcome measures
| Measure |
IBSM Challenge and MMV367 PK/PD Population Profile
n=6 Participants
A PK/PD model was built using individual PK parameter estimates of VIS participants as regression parameters to estimate the relationship between MMV367 plasma concentrations, killing and clearance rate of blood stage parasitaemia. A non-linear fixed effects (NLFE) method where population and individual parameters were both treated as fixed effects was used first to test different structural models and obtain initial parameter estimates. (non-linear mixed effects (NLME)was then used with the selected structural model and parameterization as in the NLFE model to estimate the between-subject variability on selected parameters. The MIC, MPC90, and the PRR48max were derived from the final PK/PD model.
|
Cohort 1: MMV367 90mg
IBSM challenge and MMV367
P. falciparum IBSM infection: Induced Blood Stage Malaria from infected erythrocytes.
MMV367 90mg: Single dose
|
Cohort 1: MMV367 1500mg
IBSM challenge and MMV367
P. falciparum IBSM infection: Induced Blood Stage Malaria from infected erythrocytes.
MMV367 1500mg: Single dose
|
Cohort 2: MMV367 3mg
IBSM challenge and MMV367
P. falciparum IBSM infection: Induced Blood Stage Malaria from infected erythrocytes.
MMV367 3mg: Single dose
|
Cohort 2: MMV367 5mg
IBSM challenge and MMV367
P. falciparum IBSM infection: Induced Blood Stage Malaria from infected erythrocytes.
MMV367 5mg: Single dose
|
Cohort 2: MMV367 10mg
IBSM challenge and MMV367
P. falciparum IBSM infection: Induced Blood Stage Malaria from infected erythrocytes.
MMV367 10mg: Single dose
|
|---|---|---|---|---|---|---|
|
Emax
|
0.35 Maximum clearance rate (1/hour)
Interval 0.23 to 0.46
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 8 (IMP dosing) until Day 27 (End of Study)Population: Calculated using the combined data from all doses/arms/groups in both period 1 and 2, as prespecified in section 10 of the Statistical Analysis Plan. The PKPD relationship was identified using SysFit as an Emax model with the parameters estimated from the parasitaemia data.
Half Maximal Effective Concentration PK/PD dataset contains the individual information from all arms including date and time of inoculum administration, MMV367 dose; MMV367 plasma PK concentrations; total parasitemia counts by 18S qPCR; gametocytemia counts by pfs25, pfMGET and pfSBP-1 if relevant; and typical covariates such as age, body weight, height, sex and race, to build the model and derive outcome results.
Outcome measures
| Measure |
IBSM Challenge and MMV367 PK/PD Population Profile
n=12 Participants
A PK/PD model was built using individual PK parameter estimates of VIS participants as regression parameters to estimate the relationship between MMV367 plasma concentrations, killing and clearance rate of blood stage parasitaemia. A non-linear fixed effects (NLFE) method where population and individual parameters were both treated as fixed effects was used first to test different structural models and obtain initial parameter estimates. (non-linear mixed effects (NLME)was then used with the selected structural model and parameterization as in the NLFE model to estimate the between-subject variability on selected parameters. The MIC, MPC90, and the PRR48max were derived from the final PK/PD model.
|
Cohort 1: MMV367 90mg
IBSM challenge and MMV367
P. falciparum IBSM infection: Induced Blood Stage Malaria from infected erythrocytes.
MMV367 90mg: Single dose
|
Cohort 1: MMV367 1500mg
IBSM challenge and MMV367
P. falciparum IBSM infection: Induced Blood Stage Malaria from infected erythrocytes.
MMV367 1500mg: Single dose
|
Cohort 2: MMV367 3mg
IBSM challenge and MMV367
P. falciparum IBSM infection: Induced Blood Stage Malaria from infected erythrocytes.
MMV367 3mg: Single dose
|
Cohort 2: MMV367 5mg
IBSM challenge and MMV367
P. falciparum IBSM infection: Induced Blood Stage Malaria from infected erythrocytes.
MMV367 5mg: Single dose
|
Cohort 2: MMV367 10mg
IBSM challenge and MMV367
P. falciparum IBSM infection: Induced Blood Stage Malaria from infected erythrocytes.
MMV367 10mg: Single dose
|
|---|---|---|---|---|---|---|
|
EC50
|
15 ng/mL
Interval 12.0 to 18.0
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 8 (IMP dosing) until Day 27 (End of Study)Population: Calculated using the combined data from all doses/arms/groups in both period 1 and 2, as prespecified in section 10 of the Statistical Analysis Plan.
MIC is defined as the concentration when drug killing equals the parasite growth, i.e., the time at which the minimum parasite concentration is observed. Calculated using the combined data from all doses/arms/groups in both period 1 and 2, as prespecified in section 10 of the Statistical Analysis Plan.
Outcome measures
| Measure |
IBSM Challenge and MMV367 PK/PD Population Profile
n=12 Participants
A PK/PD model was built using individual PK parameter estimates of VIS participants as regression parameters to estimate the relationship between MMV367 plasma concentrations, killing and clearance rate of blood stage parasitaemia. A non-linear fixed effects (NLFE) method where population and individual parameters were both treated as fixed effects was used first to test different structural models and obtain initial parameter estimates. (non-linear mixed effects (NLME)was then used with the selected structural model and parameterization as in the NLFE model to estimate the between-subject variability on selected parameters. The MIC, MPC90, and the PRR48max were derived from the final PK/PD model.
|
Cohort 1: MMV367 90mg
IBSM challenge and MMV367
P. falciparum IBSM infection: Induced Blood Stage Malaria from infected erythrocytes.
MMV367 90mg: Single dose
|
Cohort 1: MMV367 1500mg
IBSM challenge and MMV367
P. falciparum IBSM infection: Induced Blood Stage Malaria from infected erythrocytes.
MMV367 1500mg: Single dose
|
Cohort 2: MMV367 3mg
IBSM challenge and MMV367
P. falciparum IBSM infection: Induced Blood Stage Malaria from infected erythrocytes.
MMV367 3mg: Single dose
|
Cohort 2: MMV367 5mg
IBSM challenge and MMV367
P. falciparum IBSM infection: Induced Blood Stage Malaria from infected erythrocytes.
MMV367 5mg: Single dose
|
Cohort 2: MMV367 10mg
IBSM challenge and MMV367
P. falciparum IBSM infection: Induced Blood Stage Malaria from infected erythrocytes.
MMV367 10mg: Single dose
|
|---|---|---|---|---|---|---|
|
MIC
|
6.3 ng/mL
Interval 5.2 to 7.8
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 8 (IMP dosing) until Day 27 (End of Study)Population: Calculated using the combined data from all doses/arms/groups in both period 1 and 2, as prespecified in section 10 of the Statistical Analysis Plan.
MPC90 is defined as the concentration at which the clearance effect is at 90% of the maximum. Calculated using the combined data from all doses/arms/groups in both period 1 and 2, as prespecified in section 10 of the Statistical Analysis Plan. PK/PD dataset contains the individual information from all arms including date and time of inoculum administration, MMV367 dose; MMV367 plasma PK concentrations; total parasitemia counts by 18S qPCR; gametocytemia counts by pfs25, pfMGET and pfSBP-1 if relevant; and typical covariates such as age, body weight, height, sex and race, to build the model and derive outcome results.
Outcome measures
| Measure |
IBSM Challenge and MMV367 PK/PD Population Profile
n=12 Participants
A PK/PD model was built using individual PK parameter estimates of VIS participants as regression parameters to estimate the relationship between MMV367 plasma concentrations, killing and clearance rate of blood stage parasitaemia. A non-linear fixed effects (NLFE) method where population and individual parameters were both treated as fixed effects was used first to test different structural models and obtain initial parameter estimates. (non-linear mixed effects (NLME)was then used with the selected structural model and parameterization as in the NLFE model to estimate the between-subject variability on selected parameters. The MIC, MPC90, and the PRR48max were derived from the final PK/PD model.
|
Cohort 1: MMV367 90mg
IBSM challenge and MMV367
P. falciparum IBSM infection: Induced Blood Stage Malaria from infected erythrocytes.
MMV367 90mg: Single dose
|
Cohort 1: MMV367 1500mg
IBSM challenge and MMV367
P. falciparum IBSM infection: Induced Blood Stage Malaria from infected erythrocytes.
MMV367 1500mg: Single dose
|
Cohort 2: MMV367 3mg
IBSM challenge and MMV367
P. falciparum IBSM infection: Induced Blood Stage Malaria from infected erythrocytes.
MMV367 3mg: Single dose
|
Cohort 2: MMV367 5mg
IBSM challenge and MMV367
P. falciparum IBSM infection: Induced Blood Stage Malaria from infected erythrocytes.
MMV367 5mg: Single dose
|
Cohort 2: MMV367 10mg
IBSM challenge and MMV367
P. falciparum IBSM infection: Induced Blood Stage Malaria from infected erythrocytes.
MMV367 10mg: Single dose
|
|---|---|---|---|---|---|---|
|
MPC90
|
54 ng/mL
Interval 43.0 to 68.0
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 8 (IMP dosing) until Day 27 (End of Study)Population: 2 3mg participants were excluded from the PRR48 calculation and 1 participant was excluded from the 5mg PRR48 calculation due to non-adequate fits. Riamet was administered due to parasitaemia and clinical symptoms to participants 108 \& 110 \[3mg\], 107 \&112 \[5 mg\], \& 109 \[10mg\]), parasite regrowth 106 \[20mg\], or due to positive COVID-19 test (111 \[3mg\]). 102 \& 103 (20mg), 101 \& 105 (90mg), \& 104 (1500mg) all received definitive antimalarial treatment on Day24 per protocol.
PRR48 is given as the reduction of values on log10 transformed scale. Only MMV\_MMV367\_22\_01 data was used. PRR48 provides an estimate of the efficacy of an anti-malarial treatment. It is the ratio of parasite density over a 48-hour period, estimated using the slope of the optimal fit of the log-linear relationship of parasitemia decay. Optimal fit is derived using geometric mean parasitemia data (i.e. 18S qPCR measuring all blood stage malaria parasites). The optimal fit of the log-linear parasitemia decay by time relationship is determined using left and right censoring to systematically remove potential lag and tail phases of parasitemia decay. PRR48 was calculated for each participant using daily PCR data. If the model fit was adequate (overall model p-value\<0.001), the slope and corresponding SE from the log-linear regression was used to calculate overall dose-specific PRR48. Participants without adequate model fits were excluded from all dose-specific PRR48 calculations.
Outcome measures
| Measure |
IBSM Challenge and MMV367 PK/PD Population Profile
n=3 Participants
A PK/PD model was built using individual PK parameter estimates of VIS participants as regression parameters to estimate the relationship between MMV367 plasma concentrations, killing and clearance rate of blood stage parasitaemia. A non-linear fixed effects (NLFE) method where population and individual parameters were both treated as fixed effects was used first to test different structural models and obtain initial parameter estimates. (non-linear mixed effects (NLME)was then used with the selected structural model and parameterization as in the NLFE model to estimate the between-subject variability on selected parameters. The MIC, MPC90, and the PRR48max were derived from the final PK/PD model.
|
Cohort 1: MMV367 90mg
n=2 Participants
IBSM challenge and MMV367
P. falciparum IBSM infection: Induced Blood Stage Malaria from infected erythrocytes.
MMV367 90mg: Single dose
|
Cohort 1: MMV367 1500mg
n=1 Participants
IBSM challenge and MMV367
P. falciparum IBSM infection: Induced Blood Stage Malaria from infected erythrocytes.
MMV367 1500mg: Single dose
|
Cohort 2: MMV367 3mg
n=1 Participants
IBSM challenge and MMV367
P. falciparum IBSM infection: Induced Blood Stage Malaria from infected erythrocytes.
MMV367 3mg: Single dose
|
Cohort 2: MMV367 5mg
n=1 Participants
IBSM challenge and MMV367
P. falciparum IBSM infection: Induced Blood Stage Malaria from infected erythrocytes.
MMV367 5mg: Single dose
|
Cohort 2: MMV367 10mg
n=1 Participants
IBSM challenge and MMV367
P. falciparum IBSM infection: Induced Blood Stage Malaria from infected erythrocytes.
MMV367 10mg: Single dose
|
|---|---|---|---|---|---|---|
|
Parasite Killing Achieved Within 48 Hours, PRR48
|
4.75 log[(parasites/mL)/hour]
Interval 4.29 to 5.2
|
3.64 log[(parasites/mL)/hour]
Interval 3.24 to 4.03
|
4.65 log[(parasites/mL)/hour]
Interval 3.97 to 5.32
|
4.75 log[(parasites/mL)/hour]
Interval 4.17 to 5.34
|
1.81 log[(parasites/mL)/hour]
Interval 1.6 to 2.01
|
2.14 log[(parasites/mL)/hour]
Interval 1.54 to 2.74
|
Adverse Events
MMV367 3mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
MMV367 5mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
MMV367 10mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
MMV367 20mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
MMV367 90mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
MMV367 1500mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MMV367 3mg
n=3 participants at risk
IBSM challenge and MMV367
MMV367 3mg: Single dose
P. falciparum IBSM infection: Induced Blood Stage Malaria from infected erythrocytes.
|
MMV367 5mg
n=2 participants at risk
IBSM challenge and MMV367
P. falciparum IBSM infection: Induced Blood Stage Malaria from infected erythrocytes.
MMV367 5mg: Single dose
|
MMV367 10mg
n=1 participants at risk
IBSM challenge and MMV367
P. falciparum IBSM infection: Induced Blood Stage Malaria from infected erythrocytes.
MMV367 10mg: Single dose
|
MMV367 20mg
n=3 participants at risk
IBSM challenge and MMV367
P. falciparum IBSM infection: Induced Blood Stage Malaria from infected erythrocytes.
MMV367 20mg: Single dose
|
MMV367 90mg
n=2 participants at risk
IBSM challenge and MMV367
P. falciparum IBSM infection: Induced Blood Stage Malaria from infected erythrocytes.
MMV367 90mg: Single dose
|
MMV367 1500mg
n=1 participants at risk
IBSM challenge and MMV367
P. falciparum IBSM infection: Induced Blood Stage Malaria from infected erythrocytes.
MMV367 1500mg: Single dose
|
|---|---|---|---|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
33.3%
1/3 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from IMP administration on day 8 until End of Study on day 27.
TEAEs include all AEs reported from the time of IMP dosing to EOS, regardless of relatedness to inoculum or IMP.
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from IMP administration on day 8 until End of Study on day 27.
TEAEs include all AEs reported from the time of IMP dosing to EOS, regardless of relatedness to inoculum or IMP.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected from IMP administration on day 8 until End of Study on day 27.
TEAEs include all AEs reported from the time of IMP dosing to EOS, regardless of relatedness to inoculum or IMP.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from IMP administration on day 8 until End of Study on day 27.
TEAEs include all AEs reported from the time of IMP dosing to EOS, regardless of relatedness to inoculum or IMP.
|
50.0%
1/2 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from IMP administration on day 8 until End of Study on day 27.
TEAEs include all AEs reported from the time of IMP dosing to EOS, regardless of relatedness to inoculum or IMP.
|
100.0%
1/1 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from IMP administration on day 8 until End of Study on day 27.
TEAEs include all AEs reported from the time of IMP dosing to EOS, regardless of relatedness to inoculum or IMP.
|
|
Investigations
Electrocardiogram T wave inversion
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from IMP administration on day 8 until End of Study on day 27.
TEAEs include all AEs reported from the time of IMP dosing to EOS, regardless of relatedness to inoculum or IMP.
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from IMP administration on day 8 until End of Study on day 27.
TEAEs include all AEs reported from the time of IMP dosing to EOS, regardless of relatedness to inoculum or IMP.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected from IMP administration on day 8 until End of Study on day 27.
TEAEs include all AEs reported from the time of IMP dosing to EOS, regardless of relatedness to inoculum or IMP.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from IMP administration on day 8 until End of Study on day 27.
TEAEs include all AEs reported from the time of IMP dosing to EOS, regardless of relatedness to inoculum or IMP.
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from IMP administration on day 8 until End of Study on day 27.
TEAEs include all AEs reported from the time of IMP dosing to EOS, regardless of relatedness to inoculum or IMP.
|
100.0%
1/1 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from IMP administration on day 8 until End of Study on day 27.
TEAEs include all AEs reported from the time of IMP dosing to EOS, regardless of relatedness to inoculum or IMP.
|
|
Investigations
Gamma-glutamyltransferase increased
|
33.3%
1/3 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from IMP administration on day 8 until End of Study on day 27.
TEAEs include all AEs reported from the time of IMP dosing to EOS, regardless of relatedness to inoculum or IMP.
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from IMP administration on day 8 until End of Study on day 27.
TEAEs include all AEs reported from the time of IMP dosing to EOS, regardless of relatedness to inoculum or IMP.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected from IMP administration on day 8 until End of Study on day 27.
TEAEs include all AEs reported from the time of IMP dosing to EOS, regardless of relatedness to inoculum or IMP.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from IMP administration on day 8 until End of Study on day 27.
TEAEs include all AEs reported from the time of IMP dosing to EOS, regardless of relatedness to inoculum or IMP.
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from IMP administration on day 8 until End of Study on day 27.
TEAEs include all AEs reported from the time of IMP dosing to EOS, regardless of relatedness to inoculum or IMP.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected from IMP administration on day 8 until End of Study on day 27.
TEAEs include all AEs reported from the time of IMP dosing to EOS, regardless of relatedness to inoculum or IMP.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from IMP administration on day 8 until End of Study on day 27.
TEAEs include all AEs reported from the time of IMP dosing to EOS, regardless of relatedness to inoculum or IMP.
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from IMP administration on day 8 until End of Study on day 27.
TEAEs include all AEs reported from the time of IMP dosing to EOS, regardless of relatedness to inoculum or IMP.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected from IMP administration on day 8 until End of Study on day 27.
TEAEs include all AEs reported from the time of IMP dosing to EOS, regardless of relatedness to inoculum or IMP.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from IMP administration on day 8 until End of Study on day 27.
TEAEs include all AEs reported from the time of IMP dosing to EOS, regardless of relatedness to inoculum or IMP.
|
50.0%
1/2 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from IMP administration on day 8 until End of Study on day 27.
TEAEs include all AEs reported from the time of IMP dosing to EOS, regardless of relatedness to inoculum or IMP.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected from IMP administration on day 8 until End of Study on day 27.
TEAEs include all AEs reported from the time of IMP dosing to EOS, regardless of relatedness to inoculum or IMP.
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from IMP administration on day 8 until End of Study on day 27.
TEAEs include all AEs reported from the time of IMP dosing to EOS, regardless of relatedness to inoculum or IMP.
|
50.0%
1/2 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from IMP administration on day 8 until End of Study on day 27.
TEAEs include all AEs reported from the time of IMP dosing to EOS, regardless of relatedness to inoculum or IMP.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected from IMP administration on day 8 until End of Study on day 27.
TEAEs include all AEs reported from the time of IMP dosing to EOS, regardless of relatedness to inoculum or IMP.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from IMP administration on day 8 until End of Study on day 27.
TEAEs include all AEs reported from the time of IMP dosing to EOS, regardless of relatedness to inoculum or IMP.
|
50.0%
1/2 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from IMP administration on day 8 until End of Study on day 27.
TEAEs include all AEs reported from the time of IMP dosing to EOS, regardless of relatedness to inoculum or IMP.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected from IMP administration on day 8 until End of Study on day 27.
TEAEs include all AEs reported from the time of IMP dosing to EOS, regardless of relatedness to inoculum or IMP.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from IMP administration on day 8 until End of Study on day 27.
TEAEs include all AEs reported from the time of IMP dosing to EOS, regardless of relatedness to inoculum or IMP.
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from IMP administration on day 8 until End of Study on day 27.
TEAEs include all AEs reported from the time of IMP dosing to EOS, regardless of relatedness to inoculum or IMP.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected from IMP administration on day 8 until End of Study on day 27.
TEAEs include all AEs reported from the time of IMP dosing to EOS, regardless of relatedness to inoculum or IMP.
|
33.3%
1/3 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from IMP administration on day 8 until End of Study on day 27.
TEAEs include all AEs reported from the time of IMP dosing to EOS, regardless of relatedness to inoculum or IMP.
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from IMP administration on day 8 until End of Study on day 27.
TEAEs include all AEs reported from the time of IMP dosing to EOS, regardless of relatedness to inoculum or IMP.
|
100.0%
1/1 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from IMP administration on day 8 until End of Study on day 27.
TEAEs include all AEs reported from the time of IMP dosing to EOS, regardless of relatedness to inoculum or IMP.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from IMP administration on day 8 until End of Study on day 27.
TEAEs include all AEs reported from the time of IMP dosing to EOS, regardless of relatedness to inoculum or IMP.
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from IMP administration on day 8 until End of Study on day 27.
TEAEs include all AEs reported from the time of IMP dosing to EOS, regardless of relatedness to inoculum or IMP.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected from IMP administration on day 8 until End of Study on day 27.
TEAEs include all AEs reported from the time of IMP dosing to EOS, regardless of relatedness to inoculum or IMP.
|
33.3%
1/3 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from IMP administration on day 8 until End of Study on day 27.
TEAEs include all AEs reported from the time of IMP dosing to EOS, regardless of relatedness to inoculum or IMP.
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from IMP administration on day 8 until End of Study on day 27.
TEAEs include all AEs reported from the time of IMP dosing to EOS, regardless of relatedness to inoculum or IMP.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected from IMP administration on day 8 until End of Study on day 27.
TEAEs include all AEs reported from the time of IMP dosing to EOS, regardless of relatedness to inoculum or IMP.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from IMP administration on day 8 until End of Study on day 27.
TEAEs include all AEs reported from the time of IMP dosing to EOS, regardless of relatedness to inoculum or IMP.
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from IMP administration on day 8 until End of Study on day 27.
TEAEs include all AEs reported from the time of IMP dosing to EOS, regardless of relatedness to inoculum or IMP.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected from IMP administration on day 8 until End of Study on day 27.
TEAEs include all AEs reported from the time of IMP dosing to EOS, regardless of relatedness to inoculum or IMP.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from IMP administration on day 8 until End of Study on day 27.
TEAEs include all AEs reported from the time of IMP dosing to EOS, regardless of relatedness to inoculum or IMP.
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from IMP administration on day 8 until End of Study on day 27.
TEAEs include all AEs reported from the time of IMP dosing to EOS, regardless of relatedness to inoculum or IMP.
|
100.0%
1/1 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from IMP administration on day 8 until End of Study on day 27.
TEAEs include all AEs reported from the time of IMP dosing to EOS, regardless of relatedness to inoculum or IMP.
|
|
General disorders
Discomfort
|
33.3%
1/3 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from IMP administration on day 8 until End of Study on day 27.
TEAEs include all AEs reported from the time of IMP dosing to EOS, regardless of relatedness to inoculum or IMP.
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from IMP administration on day 8 until End of Study on day 27.
TEAEs include all AEs reported from the time of IMP dosing to EOS, regardless of relatedness to inoculum or IMP.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected from IMP administration on day 8 until End of Study on day 27.
TEAEs include all AEs reported from the time of IMP dosing to EOS, regardless of relatedness to inoculum or IMP.
|
33.3%
1/3 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from IMP administration on day 8 until End of Study on day 27.
TEAEs include all AEs reported from the time of IMP dosing to EOS, regardless of relatedness to inoculum or IMP.
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from IMP administration on day 8 until End of Study on day 27.
TEAEs include all AEs reported from the time of IMP dosing to EOS, regardless of relatedness to inoculum or IMP.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected from IMP administration on day 8 until End of Study on day 27.
TEAEs include all AEs reported from the time of IMP dosing to EOS, regardless of relatedness to inoculum or IMP.
|
|
General disorders
Fatigue
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from IMP administration on day 8 until End of Study on day 27.
TEAEs include all AEs reported from the time of IMP dosing to EOS, regardless of relatedness to inoculum or IMP.
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from IMP administration on day 8 until End of Study on day 27.
TEAEs include all AEs reported from the time of IMP dosing to EOS, regardless of relatedness to inoculum or IMP.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected from IMP administration on day 8 until End of Study on day 27.
TEAEs include all AEs reported from the time of IMP dosing to EOS, regardless of relatedness to inoculum or IMP.
|
33.3%
1/3 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from IMP administration on day 8 until End of Study on day 27.
TEAEs include all AEs reported from the time of IMP dosing to EOS, regardless of relatedness to inoculum or IMP.
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from IMP administration on day 8 until End of Study on day 27.
TEAEs include all AEs reported from the time of IMP dosing to EOS, regardless of relatedness to inoculum or IMP.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected from IMP administration on day 8 until End of Study on day 27.
TEAEs include all AEs reported from the time of IMP dosing to EOS, regardless of relatedness to inoculum or IMP.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from IMP administration on day 8 until End of Study on day 27.
TEAEs include all AEs reported from the time of IMP dosing to EOS, regardless of relatedness to inoculum or IMP.
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from IMP administration on day 8 until End of Study on day 27.
TEAEs include all AEs reported from the time of IMP dosing to EOS, regardless of relatedness to inoculum or IMP.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected from IMP administration on day 8 until End of Study on day 27.
TEAEs include all AEs reported from the time of IMP dosing to EOS, regardless of relatedness to inoculum or IMP.
|
33.3%
1/3 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from IMP administration on day 8 until End of Study on day 27.
TEAEs include all AEs reported from the time of IMP dosing to EOS, regardless of relatedness to inoculum or IMP.
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from IMP administration on day 8 until End of Study on day 27.
TEAEs include all AEs reported from the time of IMP dosing to EOS, regardless of relatedness to inoculum or IMP.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected from IMP administration on day 8 until End of Study on day 27.
TEAEs include all AEs reported from the time of IMP dosing to EOS, regardless of relatedness to inoculum or IMP.
|
Additional Information
Director, Program Leadership and Strategy
Medicines for Malaria Venture
Phone: +41 22 555 03 00
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place