Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06408857
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-10
First Post:
2024-05-07
Brief Title:
Study To Evaluate Safety Tolerability and Pharmacokinetics of MAM01 in African Population
Sponsor:
Bill Melinda Gates Medical Research Institute
Organization:
Bill Melinda Gates Medical Research Institute
Study Overview
Official Title:
A Phase 1b Age De-EscalationDose Escalation Trial to Evaluate the Safety Tolerability and Pharmacokinetics of MAM01 in Adults Children and Special Pediatric Populations in a Setting of Perennial Malaria Transmission in Africa
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will test a new drug MAM01 to find which doses are safe and could help prevent people from getting malaria The study will take place in parts of Africa where malaria is common Parts A and B of the study will first test single doses of MAM01 in healthy adults then after safety review in older children and then after additional safety review in infants Part C will then test single doses of MAM01 in children and infants who have a medical problem that could put them at greater risk if they get malaria
Detailed Description:
This is a Phase 1b age de-escalationdose escalation trial that will be conducted in a setting of perennial high Plasmodium falciparum malaria parasite transmission in Africa The study will be conducted in 3 parts Part A Age De-escalationDose Escalation in Adults and Older Children Part B Age De-escalationDose Escalation in Younger Children and Part C Special Pediatric Populations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None