Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06565208
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
First in Human SADMAD Safety and PK Study With Adult DMD Safety and PK Cohort
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase 1 Randomized Double-blind Placebo-controlled Staggered Parallel Single and Multiple Ascending Dose and Food Effect Study to Evaluate the Safety and PK of Oral SAT-3247 in Healthy Volunteers and Participants With DMD
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a first-in-human FIH Phase 1 study of orally administered SAT-3247 in healthy adult volunteers HVs and adult participants with DMD to determine safety tolerability pharmacokinetics and pharmacodynamics
Detailed Description:
This is a first-in-human FIH Phase 1 study of orally administered SAT-3247 in healthy volunteers HVs and adult participants with DMD The study will be conducted in 4 parts
Part A is a Single Ascending Dose SAD part that will enroll approximately 40 HVs in up to 5 dose cohorts Each participant will receive a single oral dose of SAT 3247 or matched placebo on Day 1 each cohort will receive a higher dose than the prior cohort Part B is a Multiple Ascending Dose MAD part that will enroll approximately 32 HVs in up to 4 sequential dose cohorts Each participant will receive a daily oral dose of SAT-3247 or matched placebo on Day 1 to Day 7 each cohort will receive a higher dose than the prior cohort Part C will assess the effect of food on the PK of SAT-3247 in a fixed sequence crossover design The dose to be tested will be determined by the Safety Review Committee SRC following review of safety tolerability and available PK and PD data from Part A Approximately 8 healthy participants who completed Part A at the anticipated dose level in a fasted state will crossover into a subsequent fed cohort and receive a single dose of the same randomized IP at the same dose level that they received in Part A but following a high fat meal Part D is a open-label Multiple Dose cohort that will comprise 10 adult males with genetically confirmed DMD Each participant will receive SAT-3247 once daily for 5 consecutive days of each of 4 weeks
Part A is a Single Ascending Dose SAD part that will enroll approximately 40 HVs in up to 5 dose cohorts Each participant will receive a single oral dose of SAT 3247 or matched placebo on Day 1 each cohort will receive a higher dose than the prior cohort Part B is a Multiple Ascending Dose MAD part that will enroll approximately 32 HVs in up to 4 sequential dose cohorts Each participant will receive a daily oral dose of SAT-3247 or matched placebo on Day 1 to Day 7 each cohort will receive a higher dose than the prior cohort Part C will assess the effect of food on the PK of SAT-3247 in a fixed sequence crossover design The dose to be tested will be determined by the Safety Review Committee SRC following review of safety tolerability and available PK and PD data from Part A Approximately 8 healthy participants who completed Part A at the anticipated dose level in a fasted state will crossover into a subsequent fed cohort and receive a single dose of the same randomized IP at the same dose level that they received in Part A but following a high fat meal Part D is a open-label Multiple Dose cohort that will comprise 10 adult males with genetically confirmed DMD Each participant will receive SAT-3247 once daily for 5 consecutive days of each of 4 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None