Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-25 @ 8:15 PM
Study NCT ID:
NCT04672135
Status:
COMPLETED
Last Update Posted:
2022-05-19
First Post:
2020-11-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase 1 (First in Human) Randomized, Double-blind, Placebo-controlled SAD, MAD Study With Oral REM0046127
Sponsor:
reMYND
Organization:
Study Overview
Official Title:
A Phase 1 (First in Human) Randomized, Double-blind, Placebo-controlled SAD, MAD Study With an Adaptive Dose Design to Evaluate the Safety, Tolerability, and Pharmacokinetics of REM0046127 in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2022-05
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 is a phase 1 randomized double blind, first in human (FIH) study with the novel oral Alzheimer drug candidate REM0046127, which consists of two main parts, a single ascending dose (SAD) study with 7 cohorts followed by a multiple ascending dose (MAD) study with 2 cohorts.
Detailed Description:
SAD
As a baseline, 5 cohorts of 8 young healthy males are foreseen, with a repeat to assess food impact and an additional elderly cohort. Depending on the early FIH findings, the number of cohorts could be more or less. FIH studies include initially only males due to the incomplete nature of preclinical reproductive toxicology studies
* Treatment duration: single day
* Each cohort:
* 2 volunteers on placebos, of which 1 sentinel
* 6 volunteers on study drug, of which 1 sentinel
* Timing for each cohort will be about 21 days
* Subjects will be screened for selection from day -21 to day -1 before starting the experimental phase of each cohort
* First the 2 sentinels will be dosed
* Following the review of sentinel safety and tolerability data through the Data Safety Monitoring Board (DSMB) after one day or 2 half-life times following the sentinel dosing, the remaining 1+5 subjects will be randomized and dosed approximately 7 days after the sentinels
MAD
* First cohort of 10 healthy young male subjects. This cohort can be initiated after the food interaction has been assessed in the last safe SAD cohort, and does not need to wait for the elderly cohort.
* Second cohort of 12 healthy elderly subjects:
* The 1st cohort of healthy young male at about 75% of the Maximum Tolerated Dose (MTD) of the SAD
* The 2nd cohort of healthy older male and female (not of child-bearing potential) at about 50 or 100% of the highest tolerable dose of the SAD, depending on the observations in the 1st MAD cohort to assess potential impact of age on Pharmacokinetics (PK)
* Treatment duration: 7 days
* Timing for each cohort will be about 35 days
* Subjects will be screened for selection from day -21 to day -1 before starting the experimental phase each cohort
* First the sentinels will be dosed
* Following the review of sentinel safety and tolerability data through the DSMB, the remaining subjects will be randomized and dosed approximately 14 days later
* According to plan the sentinels of the 2nd cohort will be dosed about 35 days after the sentinels of the 1st cohort.
As a baseline, 5 cohorts of 8 young healthy males are foreseen, with a repeat to assess food impact and an additional elderly cohort. Depending on the early FIH findings, the number of cohorts could be more or less. FIH studies include initially only males due to the incomplete nature of preclinical reproductive toxicology studies
* Treatment duration: single day
* Each cohort:
* 2 volunteers on placebos, of which 1 sentinel
* 6 volunteers on study drug, of which 1 sentinel
* Timing for each cohort will be about 21 days
* Subjects will be screened for selection from day -21 to day -1 before starting the experimental phase of each cohort
* First the 2 sentinels will be dosed
* Following the review of sentinel safety and tolerability data through the Data Safety Monitoring Board (DSMB) after one day or 2 half-life times following the sentinel dosing, the remaining 1+5 subjects will be randomized and dosed approximately 7 days after the sentinels
MAD
* First cohort of 10 healthy young male subjects. This cohort can be initiated after the food interaction has been assessed in the last safe SAD cohort, and does not need to wait for the elderly cohort.
* Second cohort of 12 healthy elderly subjects:
* The 1st cohort of healthy young male at about 75% of the Maximum Tolerated Dose (MTD) of the SAD
* The 2nd cohort of healthy older male and female (not of child-bearing potential) at about 50 or 100% of the highest tolerable dose of the SAD, depending on the observations in the 1st MAD cohort to assess potential impact of age on Pharmacokinetics (PK)
* Treatment duration: 7 days
* Timing for each cohort will be about 35 days
* Subjects will be screened for selection from day -21 to day -1 before starting the experimental phase each cohort
* First the sentinels will be dosed
* Following the review of sentinel safety and tolerability data through the DSMB, the remaining subjects will be randomized and dosed approximately 14 days later
* According to plan the sentinels of the 2nd cohort will be dosed about 35 days after the sentinels of the 1st cohort.
Study Oversight
Has Oversight DMC:
True
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?: