Ignite Creation Date:
2024-05-06 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 2:17 PM
Study NCT ID:
NCT05118386
Status:
COMPLETED
Last Update Posted:
2024-05-20
First Post:
2021-10-06
Brief Title:
Safety Tolerability and Pharmacokinetics of RSV Monoclonal Antibody RSM01 in Healthy Adults
Sponsor:
Bill Melinda Gates Medical Research Institute
Organization:
Bill Melinda Gates Medical Research Institute
Study Overview
Official Title:
A Phase 1 Randomized Double-blind Placebo-Controlled Study to Evaluate the Safety Tolerability and Pharmacokinetics of Single Ascending Doses of RSM01 a Monoclonal Antibody Targeting Respiratory Syncytial Virus in Healthy Adults
Status:
COMPLETED
Status Verified Date:
2023-12
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:
Gates MRI-RSM01-101 was a Phase 1 randomized double-blind placebo-controlled dose-escalation study to evaluate the safety and tolerability pharmacokinetics occurrence of Anti-drug antibody ADA and assessment of neutralizing antibody against RSV after administration of single intravenous or intramuscular doses of RSM01 to healthy adults
Detailed Description:
Respiratory syncytial virus RSV is the most common cause of lower respiratory tract infection LRTI among infants and young children resulting in annual epidemics worldwide
RSM01 a monoclonal antibody targeting RSV may potentially provide an effective method to protect infants from RSV disease based on its potency and an extended half-life that is expected to support once-per-RSV-season administration
This study was a first-in-human evaluation of RSM01 in healthy male and female adults with the goal of characterizing the safety and tolerability of a range of single doses of RSM01 to enable determination of appropriate doses to be administered to infants in a future study Enrollment was planned at a single study center in the United States 56 participants were enrolled 48 participants received RSM01 and 8 participants received Placebo Participants were followed for approximately 5 months 151 days after dosing
RSM01 a monoclonal antibody targeting RSV may potentially provide an effective method to protect infants from RSV disease based on its potency and an extended half-life that is expected to support once-per-RSV-season administration
This study was a first-in-human evaluation of RSM01 in healthy male and female adults with the goal of characterizing the safety and tolerability of a range of single doses of RSM01 to enable determination of appropriate doses to be administered to infants in a future study Enrollment was planned at a single study center in the United States 56 participants were enrolled 48 participants received RSM01 and 8 participants received Placebo Participants were followed for approximately 5 months 151 days after dosing
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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