Clinical trial NCT06432647: A SAD and MAD Study of the Safety, Tolerability, and Pharmacokinetics of ATH-1105
Official title: ATH-1105 A Phase 1, Double-Blind, Placebo-Controlled, Single-and-Multiple-Oral-Dose, Safety, Tolerability, and Pharmacokinetic Study in Healthy Male and Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: ATH-1105
Lead sponsor: Athira Pharma
Sponsor class: INDUSTRY
Collaborators: name: Fortrea Holdings, Inc.
First posted: 2024-05-29
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: Part A: Up to 7 days post-dose, Part B: Up to 7 days post final dose on day 10
measure: Severity of Treatment-Emergent Adverse Events
timeFrame: Part A: Up to 7 days post-dose, Part B: Up to 7 days post final dose on day 10
Secondary outcomes:
measure: Area under the plasma concentration time curve (AUC)
timeFrame: Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10
measure: Time to maximum observed plasma concentration (Tmax)
timeFrame: Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10
measure: Half-life (t1/2)
timeFrame: Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10
measure: Amount of IMP excreted unchanged in the urine (Ae)
timeFrame: Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10
measure: IMP Concentration in Cerebrospinal Fluid
timeFrame: Will occur at calculated maximum plasma concentration.
measure: Accumulation Ratio (AUC) of IMP in Urine
timeFrame: Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10
measure: Accumulation Ratio (AUC) of IMP in Plasma
timeFrame: Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Fortrea Clinical Research Unit Inc.
state: Texas
Study officials:
References: