The goal of this Phase 1 interventional study is to assess the safety, tolerability and pharmacokinetics of ATH-1105 in healthy male and female participants.
The study is a Phase 1, First-In-Human study consisting of two parts (A and B). Part A will comprise a single-dose, double-blind, placebo-controlled, sequential-group design. Part B will comprise a multiple-dose, placebo-controlled, sequential-group design.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
80
Fortrea Clinical Research Unit Inc.
Dallas, Texas, United States
Incidence of Treatment-Emergent Adverse Events
Safety and tolerability of single or multiple ascending doses of ATH-1105 as measured by incidence of AEs, determined by clinical laboratory tests, physical examinations, vital signs measurements, and 12-lead ECG
Time frame: Part A: Up to 7 days post-dose, Part B: Up to 7 days post final dose on day 10
Severity of Treatment-Emergent Adverse Events
Treatment-emergent adverse events will be graded on a 1 through 5 scale, based on severity as determined by the principal investigator.
Time frame: Part A: Up to 7 days post-dose, Part B: Up to 7 days post final dose on day 10
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: Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10
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: Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10
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: Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10
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: Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Amount of IMP excreted unchanged in the urine (Ae)
Amount of IMP excreted unchanged in the urine will be determined from all collected urine samples from baseline through up to 48 hours post-dose
Time frame: Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10
IMP Concentration in Cerebrospinal Fluid
Amount of IMP in the urine will be determined from all collected CSF samples from baseline through up to 48 hours post-dose
Time frame: Will occur at calculated maximum plasma concentration.
Accumulation Ratio (AUC) of IMP in Urine
Accumulation Ratio in urine will be determined from all collected urine samples from baseline through up to 48 hours post-dose
Time frame: Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10
Accumulation Ratio (AUC) of IMP in Plasma
Accumulation Ratio in plasma will be determined from all collected plasma samples from baseline through up to 48 hours post-dose
Time frame: Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10