Ignite Creation Date:
2024-05-06 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06146374
Status:
TERMINATED
Last Update Posted:
2024-07-12
First Post:
2023-11-22
Brief Title:
Safety Study of SLV213 for the Treatment of COVID-19
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Double Blind Placebo-Controlled Multiple Ascending Dose Phase 1 Study of SLV213 in Healthy Volunteers
Status:
TERMINATED
Status Verified Date:
2023-12-26
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
DMID unanimously arrived at a recommendation to terminate the study after study met cohort halting criteria
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This Phase 1 double blind placebo-controlled study will evaluate the safety tolerability and pharmacokinetics PK of multiple ascending doses MAD of SLV213 in healthy male and female participants 18-65 years of age This study will help to select the most likely suitable dose eg at Maximum Tolerated Dose MTD for the treatment of patients with COVID-19 in a pivotal study This phase 1 double blind placebo-controlled study will consist of three sequential cohorts of 12 participants each 8 SLV213 and 4 placebo at doses of 400 mg every 12 hours Q12h 600 mg Q12h and 800 mg Q12h administered orally PO for 7 days After each cohort a Safety Review Committee SRC will evaluate the safety of the regimen before proceeding to dose the next cohort Randomization will occur into the respective cohorts as above Upon meeting the InclusionExclusion criteria subjects will begin treatment with SLV213 or placebo per their assigned cohort The primary objective is to evaluate the safety and tolerability of multiple ascending doses of SLV213 for 7 days in healthy participants
Detailed Description:
This Phase 1 double blind placebo-controlled study will evaluate the safety tolerability and pharmacokinetics PK of multiple ascending doses MAD of SLV213 in healthy male and female participants 18-65 years of age This study will help to select the most likely suitable dose eg at Maximum Tolerated Dose MTD for the treatment of patients with COVID-19 in a pivotal study This phase 1 double blind placebo-controlled study will consist of three sequential cohorts of 12 participants each 8 SLV213 and 4 placebo at doses of 400 mg every 12 hours Q12h 600 mg Q12h and 800 mg Q12h administered orally PO for 7 days After each cohort a Safety Review Committee SRC will evaluate the safety of the regimen before proceeding to dose the next cohort Randomization will occur into the respective cohorts as above Upon meeting the InclusionExclusion criteria subjects will begin treatment with SLV213 or placebo per their assigned cohort Participants will take their study drug in the fasted state prior to morning and evening meals and will remain as in-patient in the clinical trial unit CTU during all treatments and for approximately 48 hours h after the last dose for monitoring After discharge from the CTU participants will be monitored by CTU staff by telephone to assess for new adverse events and use of concomitant medication since the last visit or contact approximately weekly for three weeks Participants will be asked to return to the CTU for further assessment of moderate or severe adverse events AEs use of concomitant medications ConMeds since the last visit or contact approximately weekly for three weeks The primary objective is to evaluate the safety and tolerability of multiple ascending doses of SLV213 for 7 days in healthy participants The secondary objective is to characterize the multiple dose PK of SLV213 in healthy participants
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?:
False
Is an FDA AA801 Violation?:
None