Ignite Creation Date:
2025-12-24 @ 1:59 PM
Ignite Modification Date:
2026-02-27 @ 8:27 AM
Study NCT ID:
NCT03325595
Status:
COMPLETED
Last Update Posted:
2018-03-13
First Post:
2017-10-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Ascending Dose to Study the Safety, Tolerability, PK and PD Effects of AEF0117
Sponsor:
Aelis Farma
Organization:
Study Overview
Official Title:
A Phase 1, Single Center, Double-blind, Placebo-controlled, Dose Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Effects of Single Oral Doses of AEF0117 in Healthy Male and Female Subjects
Status:
COMPLETED
Status Verified Date:
2018-03
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:
The study is designed to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of escalating single oral doses of AEF0117 in healthy adult male and female subjects.
Detailed Description:
The overall goal of this protocol is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of escalating single oral doses of AEF0117 in healthy adult male and female subjects. This will be a single center study in healthy adult male and female subjects. The study design will be a double-blind, randomized, placebo-controlled, single period, parallel group, single dose escalation with AEF0117.
Four dose levels are planned for the study with 8 subjects (6 active and 2 placebo, 3:1 ratio) per dose level:
Dose Level I - 0.2 mg single oral dose of AEF0117 given on the morning of Day 1 Dose Level II - 0.6 mg single oral dose of AEF0117given on the morning of Day 1 Dose Level III - 2 mg single oral dose of AEF0117 given on the morning of Day 1 Dose Level IV - 6 mg single oral dose of AEF0117 given on the morning of Day 1 The planned dose escalation schema may be amended based on the emerging PK and safety data. Each subject will participate in only one dose group.
In each dosing cohort, 2 sentinel subjects (randomized 1 AEF0117: 1placebo) will be dosed and observed for safety monitoring for 24 hours prior to initiating dosing in the remaining 6 subjects (randomized 5 AEF0117: 1 placebo).
The first cohort will be administered 0.2mg. Administration of AEF0117 to the subsequent dose cohorts,0.6 mg(Cohort II), 2 mg (Cohort III), and 6 mg (Cohort IV) doses should not occur before participants in the previous dose cohort have been treated and data i.e. safety results from those participants are reviewed in accordance with the protocol.
Serial blood sample collections will be performed for 144 hours after dose administration for PK analysis, and for 48 hours after dose administration for PD analysis.
Subjects will be admitted to the research clinic at midday prior to dosing (Day -1) and remain in-house until Day 8. Randomized subjects will receive a single dose of AEF0117 on Day 1. PK samples and safety assessments will be performed pre-dose and at different times post dose. Safety monitoring (physical examinations, vital sign measurement, 12-lead electrocardiograms \[ECGs\], clinical safety laboratory tests, and adverse event monitoring) will be performed throughout the study. Psychometrics (Bond \& Lader VAS, ARCI, POMS) and C-SSRS tests will be performed.
Four dose levels are planned for the study with 8 subjects (6 active and 2 placebo, 3:1 ratio) per dose level:
Dose Level I - 0.2 mg single oral dose of AEF0117 given on the morning of Day 1 Dose Level II - 0.6 mg single oral dose of AEF0117given on the morning of Day 1 Dose Level III - 2 mg single oral dose of AEF0117 given on the morning of Day 1 Dose Level IV - 6 mg single oral dose of AEF0117 given on the morning of Day 1 The planned dose escalation schema may be amended based on the emerging PK and safety data. Each subject will participate in only one dose group.
In each dosing cohort, 2 sentinel subjects (randomized 1 AEF0117: 1placebo) will be dosed and observed for safety monitoring for 24 hours prior to initiating dosing in the remaining 6 subjects (randomized 5 AEF0117: 1 placebo).
The first cohort will be administered 0.2mg. Administration of AEF0117 to the subsequent dose cohorts,0.6 mg(Cohort II), 2 mg (Cohort III), and 6 mg (Cohort IV) doses should not occur before participants in the previous dose cohort have been treated and data i.e. safety results from those participants are reviewed in accordance with the protocol.
Serial blood sample collections will be performed for 144 hours after dose administration for PK analysis, and for 48 hours after dose administration for PD analysis.
Subjects will be admitted to the research clinic at midday prior to dosing (Day -1) and remain in-house until Day 8. Randomized subjects will receive a single dose of AEF0117 on Day 1. PK samples and safety assessments will be performed pre-dose and at different times post dose. Safety monitoring (physical examinations, vital sign measurement, 12-lead electrocardiograms \[ECGs\], clinical safety laboratory tests, and adverse event monitoring) will be performed throughout the study. Psychometrics (Bond \& Lader VAS, ARCI, POMS) and C-SSRS tests will be performed.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01DA038875 | NIH | None | https://reporter.nih.gov/quic… | View |