This Phase 1 randomized, placebo-controlled, double-blinded, first-in-human study will evaluate safety, tolerability, and pharmacokinetics of single and multiple ascending doses of ATH-1020 in healthy young and elderly subjects.
This is a Phase 1 first-in-human, 2-part adaptive study. Both Part A and Part B will be performed in a randomized, placebo-controlled, and double-blind manner. Part A - Single Ascending Dose (SAD) Part A will be a SAD study investigating multiple dose levels of ATH 1020. Part B - Multiple Ascending Dose (MAD) Part B will be a multiple ascending dose (MAD) study investigating multiple dose levels of ATH-1020. Subjects in Cohort B5 (4 subjects) will additionally undergo CSF sampling pre-dose on Day 4 and up to 3 post dose timepoints to evaluate ATH-1020 blood-brain-barrier penetration
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
32
Biotrial, Inc.
Newark, New Jersey, United States
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Safety and tolerability of single or multiple ascending doses of ATH-1020 as measured by vital signs and clinical laboratory measurements.
Time frame: Up to 12 days post initial dosing (Part A); Up to 19 days post initial dosing (Part B)
Maximum observed plasma concentration (Cmax)
Cmax will be determined from all collected plasma samples from baseline through up to 48 hours post-dose.
Time frame: Cmax will be determined from all collected plasma samples from baseline through up to 48 hours post-dose.
Time to maximum observed plasma concentration (Tmax)
Tmax will be determined from all collected plasma samples from baseline through up to 48 hours post-dose.
Time frame: Samples collected pre-dose and at predetermined timepoints within 48 hours post-dose.
Plasma concentration at the end of the dosing interval (Ctrough)
Ctrough will be determined from the last plasma sample prior to the following dose (cohort B only).
Time frame: Samples collected pre-dose and at predetermined timepoints within 24 hours post-dose.
Area under the plasma concentration time curve (AUC)
AUC will be determined from all collected plasma samples from baseline through up to 48 hours post-dose.
Time frame: Samples collected pre-dose and at predetermined timepoints within 48 hours post-dose.
Half-life (t1/2)
t1/2 will be determined from all collected plasma samples from baseline through up to 48 hours post-dose.
Time frame: Samples collected pre-dose and at predetermined timepoints within 48 hours post-dose.
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Amount of IMP excreted unchanged in the urine (Ae)
Ae will be determined from all collected urine samples from baseline through up to 24 hours post-dose (cohort B1-4 only).
Time frame: Samples collected pre-dose on Day 1 and predetermined timepoints on Day 1, 9, and 10, within 24 hours post-dose.