Healthy Volunteers
Conditions
Keywords
ATH-1105
Brief summary
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.
Detailed description
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.
Interventions
DRUGATH-1105
ATH-1105 in oral form. Participants will be administered ATH-1105 once in Part A and once daily for 10 days in Part B.
DRUGPlacebo
Placebo in oral form. Participants will be administered Placebo once in Part A and once daily for 10 days in Part B.
Sponsors
Fortrea Holdings, Inc.
Athira Pharma
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Body mass index between 18.0 and 32.0 kg/m2 inclusive. * In good health, determined by no clinically significant findings from medical history, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations at screening and check-in or predose on Day 1 * Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception * Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
Exclusion criteria
Medical Conditions: * Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder * History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance * History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs * Any of the following: 1. QTcF \>450 ms in males or \>470 ms in females 2. QRS duration \>110 ms 3. PR interval \>220 ms 4. Findings which would make QTc measurements difficult or QTc data uninterpretable. 5. History of additional risk factors for torsades de pointes * Confirmed systolic blood pressure \>140 or \<90 mmHg, diastolic blood pressure \>90 or \<50 mmHg, and pulse rate \>100 or \<40 beats per minute. * Positive hepatitis panel and/or positive human immunodeficiency virus test * Part B only: Current psychiatric disorder, suicidal ideation in the previous 2 years (as assessed by the Columbia-Suicide Severity Rating Scale \[C-SSRS\]), or a lifetime suicide attempt. Prior/concomitant therapy: * Administration of any vaccine in the 30 days prior to dosing. * Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes * Use or intend to use any prescription medications/products other than hormone replacement therapy, oral, implantable, transdermal, injectable, or intrauterine contraceptives within 14 days prior to dosing * Use or intend to use slow-release medications/products considered to still be active within 14 days prior to check-in * Use or intend to use any nonprescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations within 7 days prior to check-in
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | Part A: Up to 7 days post-dose, Part B: Up to 7 days post final dose on day 10 | 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 |
| Severity of Treatment-Emergent Adverse Events | Part A: Up to 7 days post-dose, Part B: Up to 7 days post final dose on day 10 | Treatment-emergent adverse events will be graded on a 1 through 5 scale, based on severity as determined by the principal investigator. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to maximum observed plasma concentration (Tmax) | Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10 | Tmax will be determined from all collected plasma samples from baseline through up to 48 hours post-dose. |
| Half-life (t1/2) | Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10 | t1/2 will be determined from all collected plasma samples from baseline through up to 48 hours post-dose. |
| Amount of IMP excreted unchanged in the urine (Ae) | Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10 | 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 |
| Area under the plasma concentration time curve (AUC) | Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10 | AUC will be determined from all collected plasma samples from baseline through up to 48 hours post-dose. |
| Accumulation Ratio (AUC) of IMP in Urine | Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10 | Accumulation Ratio in urine will be determined from all collected urine samples from baseline through up to 48 hours post-dose |
| Accumulation Ratio (AUC) of IMP in Plasma | Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10 | Accumulation Ratio in plasma will be determined from all collected plasma samples from baseline through up to 48 hours post-dose |
| IMP Concentration in Cerebrospinal Fluid | Will occur at calculated maximum plasma concentration. | Amount of IMP in the urine will be determined from all collected CSF samples from baseline through up to 48 hours post-dose |
| Maximum observed plasma concentration (Cmax) | Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10 | Cmax will be determined from all collected plasma samples from baseline through up to 48 hours post-dose. |
Countries
United States
Outcome results
None listed