Trial Outcomes & Findings for MMV533 Plasmodium Falciparum Volunteer Infection Study (NCT NCT05205941)
NCT ID: NCT05205941
Last Updated: 2024-12-02
Results Overview
Estimated Parasite Reduction Ratio over 48 hours (PRR48)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
9 participants
Primary outcome timeframe
48 hours
Results posted on
2024-12-02
Participant Flow
Nine (9) participants were inoculated with the malaria challenge agent, 7 of whom were subsequently administered 20 mg MMV533 (n=3), 35 mg (n=2) and 100 mg (n=2) MMV533. 2 participants were not inoculated.
Participant milestones
| Measure |
MMV533 (20 mg).
MMV 533 (20 mg) - (N=3 participants)
|
MMV 533 (35 mg)
MMV 533 (35 mg) - (N=2 participants)
|
MMV533 (100 mg)
MMV 533 (100 mg) (N=2 participants)
|
Not Treated
Not treated - (N=2 participants)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
2
|
2
|
2
|
|
Overall Study
COMPLETED
|
3
|
2
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
MMV533 Plasmodium Falciparum Volunteer Infection Study
Baseline characteristics by cohort
| Measure |
MMV533 20 mg
n=3 Participants
Participants having been dosed with MMV533 20mg
|
MMV533 35 mg
n=2 Participants
Participants having been dosed with MMV533 35mg
|
MMV533 100 mg
n=2 Participants
Participants having been dosed with MMV533 100mg
|
Not Treated
n=2 Participants
Participants not having been dosed with MMV533
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
32 years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
24.5 years
STANDARD_DEVIATION 7.8 • n=7 Participants
|
22 years
STANDARD_DEVIATION 4.2 • n=5 Participants
|
22.5 years
STANDARD_DEVIATION 2.1 • n=4 Participants
|
26 years
STANDARD_DEVIATION 8.6 • n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 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
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 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
|
|
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
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
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
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
Australia
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
BMI (kg/m2)*
|
24.17 kg/m2
STANDARD_DEVIATION 1.91 • n=5 Participants
|
23.55 kg/m2
STANDARD_DEVIATION 1.2 • n=7 Participants
|
22.45 kg/m2
STANDARD_DEVIATION 2.19 • n=5 Participants
|
27.25 kg/m2
STANDARD_DEVIATION 4.31 • n=4 Participants
|
24.33 kg/m2
STANDARD_DEVIATION 2.68 • n=21 Participants
|
PRIMARY outcome
Timeframe: 48 hoursEstimated Parasite Reduction Ratio over 48 hours (PRR48)
Outcome measures
| Measure |
MMV533 (20 mg).
n=3 Participants
MMV 533 (20 mg) - (N=3 participants)
|
MMV 533 (35 mg)
n=2 Participants
MMV 533 (35 mg) - (N=2 participants)
|
MMV533 (100 mg)
n=2 Participants
MMV 533 (100 mg) (N=2 participants)
|
|---|---|---|---|
|
The Activity of Single Oral Doses of MMV533 (Name of Investigational Medicinal Product) on Clearance of Plasmodium
|
42.17 PRR48=parasite reduction ratio 48 hours
Interval 20.23 to 87.9
|
158.03 PRR48=parasite reduction ratio 48 hours
Interval 93.62 to 266.75
|
187.57 PRR48=parasite reduction ratio 48 hours
Interval 96.72 to 363.77
|
PRIMARY outcome
Timeframe: 48 hoursEstimated Parasite Reduction Ratio over 48 hours (log10 PRR48)
Outcome measures
| Measure |
MMV533 (20 mg).
n=3 Participants
MMV 533 (20 mg) - (N=3 participants)
|
MMV 533 (35 mg)
n=2 Participants
MMV 533 (35 mg) - (N=2 participants)
|
MMV533 (100 mg)
n=2 Participants
MMV 533 (100 mg) (N=2 participants)
|
|---|---|---|---|
|
The Activity of Single Oral Doses of MMV533 (Name of Investigational Medicinal Product) on Clearance of Plasmodium
|
1.62 Log10 PRR48
Interval 1.31 to 1.94
|
2.2 Log10 PRR48
Interval 1.97 to 2.43
|
2.27 Log10 PRR48
Interval 1.99 to 2.56
|
PRIMARY outcome
Timeframe: 48 hoursPopulation: All participants (n=7) had significant regression models at the p=0.001 significance level and all contributed towards the dose specific PRR48 calculated.
Parasite Clearance Half-life after Single Oral Dose of MMV533, by Treatment Group
Outcome measures
| Measure |
MMV533 (20 mg).
n=3 Participants
MMV 533 (20 mg) - (N=3 participants)
|
MMV 533 (35 mg)
n=2 Participants
MMV 533 (35 mg) - (N=2 participants)
|
MMV533 (100 mg)
n=2 Participants
MMV 533 (100 mg) (N=2 participants)
|
|---|---|---|---|
|
The Activity of Single Oral Doses of MMV533 (Name of Investigational Medicinal Product) on Clearance of Plasmodium
|
8.89 Hours
Interval 7.43 to 11.06
|
6.57 Hours
Interval 5.96 to 7.33
|
6.36 Hours
Interval 5.64 to 7.28
|
PRIMARY outcome
Timeframe: 48 hoursNumber of volunteers whose parasitaemia levels fall below limit of quantification (LOQ) following treatment with IMP
Outcome measures
| Measure |
MMV533 (20 mg).
n=3 Participants
MMV 533 (20 mg) - (N=3 participants)
|
MMV 533 (35 mg)
n=2 Participants
MMV 533 (35 mg) - (N=2 participants)
|
MMV533 (100 mg)
n=2 Participants
MMV 533 (100 mg) (N=2 participants)
|
|---|---|---|---|
|
Participants With Parasitaemia Below Limit of Quantification (LOQ)
|
1 Participants
|
2 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 30 days post inoculationThe Total Number of Study Participants with Recrudescence of Asexual Parasitaemia within 30 days post inoculation
Outcome measures
| Measure |
MMV533 (20 mg).
n=3 Participants
MMV 533 (20 mg) - (N=3 participants)
|
MMV 533 (35 mg)
n=2 Participants
MMV 533 (35 mg) - (N=2 participants)
|
MMV533 (100 mg)
n=2 Participants
MMV 533 (100 mg) (N=2 participants)
|
|---|---|---|---|
|
Activity of Single Oral Doses of MMV533 on Clearance of Plasmodium
|
0 Participants
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 180 hours post inoculationNumber of participants experiencing a recrudescence after 180 hours
Outcome measures
| Measure |
MMV533 (20 mg).
n=3 Participants
MMV 533 (20 mg) - (N=3 participants)
|
MMV 533 (35 mg)
n=2 Participants
MMV 533 (35 mg) - (N=2 participants)
|
MMV533 (100 mg)
n=2 Participants
MMV 533 (100 mg) (N=2 participants)
|
|---|---|---|---|
|
The Activity of Single Oral Doses of MMV533 on Clearance of Plasmodium
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 312 hours post inoculationNumber of participants experiencing a recrudescence after 312 hours
Outcome measures
| Measure |
MMV533 (20 mg).
n=3 Participants
MMV 533 (20 mg) - (N=3 participants)
|
MMV 533 (35 mg)
n=2 Participants
MMV 533 (35 mg) - (N=2 participants)
|
MMV533 (100 mg)
n=2 Participants
MMV 533 (100 mg) (N=2 participants)
|
|---|---|---|---|
|
The Activity of Single Oral Doses of MMV533 on Clearance of Plasmodium
|
0 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
MMV533 20mg (Single, Oral Doses)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
MMV533 35mg (Single, Oral Doses)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
MMV533 100mg (Single, Oral Doses)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60