Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06247345
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-01-31
Brief Title:
A Phase IaIb First-in-human FIH Study for Safety Tolerability Pharmacokinetics PK and Clinical Activity Evaluation of ADEL-Y01
Sponsor:
Alzheimers Disease Expert Lab ADEL Inc
Organization:
Alzheimers Disease Expert Lab ADEL Inc
Study Overview
Official Title:
First in Human Phase IaIb Study for Safety Tolerability Pharmacokinetics and Clinical Activity Evaluation of ADEL-Y01 in Healthy Participants and in Participants with Mild Cognitive Impairment Due to Alzheimers Disease or Mild Alzheimers Disease
Status:
RECRUITING
Status Verified Date:
2024-10
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 IaIb two-part randomized placebo-controlled double-blinded first in humanFIH study to evaluate the safety tolerability PK and PD of ADEL-Y01 in healthy participants in Part 1 and participants with MCI due to AD and mild AD in Part 2 The study includes 2 parts Part 1 single ascending dose SAD and Part 2 multiple ascending dose MAD
Detailed Description:
The current standard of care SoC for Alzheimers disease AD is aimed at improving memory and alertness only There is an unmet medical need for an effective clinical treatment of neurodegeneration of AD and related dementia Adel Inc and Oscotec Inc are jointly developing a novel disease modifying immunotherapy agent ADEL-Y01 targeting tubulin associated unit tau protein accumulation in the brain ADEL-Y01 is a recombinant IgG1 class type monoclonal humanized antibody that recognizes and binds to tau protein acetylated at lysine-280 K280 thus inhibiting aggregation and propagation of tau seeds and enhancing of microglial tau clearance Administration of ADEL-Y01 has ameliorated memory impairment behavioral deficits and pathology in preclinical models This first-in-human FIH study will assess the single and multiple dose safety tolerability pharmacokinetic PK pharmacodynamic PD of ADEL-Y01 in healthy adult participants and participants with mild cognitive impairment MCI due to AD and mild AD
Part 1 SAD Part 1 will recruit up to 40 healthy participants age 18 to 65 years inclusive Up to 5 cohorts of 8 participants 6 active and 2 placebo participants per cohort will be enrolled with each participant receiving ADEL-Y01 or placebo Participants will be screened within 28 days of dose administration The participants who will meet the inclusionexclusion criteria for the study will be enrolled into the study after providing the informed consent form ICF The eligible participants will be randomized on Day -1 to receive either single dose of ADEL-Y01 or placebo on Day 1 Participants will be admitted on Day -1 and remain in the clinical research unit for at least 4 days Day 4 following completion of all schedule procedures Participants will return to the clinical research unit for additional safety and PK assessments on 7 occasions over a total of 12-weeks Each dose level will include 2 sentinel participants 1 active and 1 placebo who will be dosed first and monitored by the Investigator for at least 24 hours to check safety and tolerability Once the safety of the study intervention is ensured remaining participants will be dosed 5 active and 1 placebo The starting dose for the Part 1 SAD will be 25 mgkg Subsequent dose levels are tentatively assigned to be 75 20 50 and 100 mgkg Dose escalation to the next dose levels will not proceed until the safety and tolerability of ADEL-Y01 results over an at least 14-day assessment period have been evaluated by the Safety Review Committee SRC A randomization list will be prepared for each cohort separately No participant will be dosed more than once
Part 2 MAD Part 2 will evaluate multiple IV doses of ADEL-Y01 administered every 2 weeks Q2W for 12 weeks in participants with MCI due to AD or mild AD Thirty-three participants aged 50 to 80 years will be enrolled into 3 cohorts of 11 participants per cohort 8 active 3 placebo with each participant assigned to receive 6 doses of either ADEL-Y01 or placebo Participants will be screened within 28 days of dose administration The participants who will meet the inclusionexclusion criteria for the study will be enrolled into the study after providing the ICF The eligible participants will be randomized on Day -1 to receive either single dose of ADEL-Y01 or placebo on Day 1 Participants will be admitted on Day -1 and remain in the clinical research unit for at least 24 hours post infusion Day 2 following completion of all schedule procedures Participants will return to the clinical research unit for ADEL-Y01placebo administration andor additional safety and PK assessments on 12 occasions over a total of up to 22 weeks ie 12-weeks relative to the administration of the last dose of study intervention scheduled on Day 71 The provisional doses planned in Part 2 MAD are 75 20 and 50 mgkg administered every 2 weeks The starting dose for the MAD part will be based on both safety and PK results from the Part 1 SAD The starting dose will be selected so that anticipated repeated-dose exposure to ADEL-Y01 Cmax and AUC does not exceed the exposure at the highest dose determined to be safe and well tolerated in the SAD Depending on the Q2W ADEL-Y01 dose selected the Part 2 MAD may commence prior to completion of the SAD study part Dose escalation to the next dose levels will not proceed until the safety and tolerability of ADEL-Y01 over an at least 6-week assessment period 3 doses have been evaluated by the SRC
Part 1 SAD Part 1 will recruit up to 40 healthy participants age 18 to 65 years inclusive Up to 5 cohorts of 8 participants 6 active and 2 placebo participants per cohort will be enrolled with each participant receiving ADEL-Y01 or placebo Participants will be screened within 28 days of dose administration The participants who will meet the inclusionexclusion criteria for the study will be enrolled into the study after providing the informed consent form ICF The eligible participants will be randomized on Day -1 to receive either single dose of ADEL-Y01 or placebo on Day 1 Participants will be admitted on Day -1 and remain in the clinical research unit for at least 4 days Day 4 following completion of all schedule procedures Participants will return to the clinical research unit for additional safety and PK assessments on 7 occasions over a total of 12-weeks Each dose level will include 2 sentinel participants 1 active and 1 placebo who will be dosed first and monitored by the Investigator for at least 24 hours to check safety and tolerability Once the safety of the study intervention is ensured remaining participants will be dosed 5 active and 1 placebo The starting dose for the Part 1 SAD will be 25 mgkg Subsequent dose levels are tentatively assigned to be 75 20 50 and 100 mgkg Dose escalation to the next dose levels will not proceed until the safety and tolerability of ADEL-Y01 results over an at least 14-day assessment period have been evaluated by the Safety Review Committee SRC A randomization list will be prepared for each cohort separately No participant will be dosed more than once
Part 2 MAD Part 2 will evaluate multiple IV doses of ADEL-Y01 administered every 2 weeks Q2W for 12 weeks in participants with MCI due to AD or mild AD Thirty-three participants aged 50 to 80 years will be enrolled into 3 cohorts of 11 participants per cohort 8 active 3 placebo with each participant assigned to receive 6 doses of either ADEL-Y01 or placebo Participants will be screened within 28 days of dose administration The participants who will meet the inclusionexclusion criteria for the study will be enrolled into the study after providing the ICF The eligible participants will be randomized on Day -1 to receive either single dose of ADEL-Y01 or placebo on Day 1 Participants will be admitted on Day -1 and remain in the clinical research unit for at least 24 hours post infusion Day 2 following completion of all schedule procedures Participants will return to the clinical research unit for ADEL-Y01placebo administration andor additional safety and PK assessments on 12 occasions over a total of up to 22 weeks ie 12-weeks relative to the administration of the last dose of study intervention scheduled on Day 71 The provisional doses planned in Part 2 MAD are 75 20 and 50 mgkg administered every 2 weeks The starting dose for the MAD part will be based on both safety and PK results from the Part 1 SAD The starting dose will be selected so that anticipated repeated-dose exposure to ADEL-Y01 Cmax and AUC does not exceed the exposure at the highest dose determined to be safe and well tolerated in the SAD Depending on the Q2W ADEL-Y01 dose selected the Part 2 MAD may commence prior to completion of the SAD study part Dose escalation to the next dose levels will not proceed until the safety and tolerability of ADEL-Y01 over an at least 6-week assessment period 3 doses have been evaluated by the SRC
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