## Protocol Section
### Identification Module
**NCT ID:** NCT06432647

**Brief Title:** 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

#### Organization Study ID Info
**ID:** ATH-1105-0101
#### Organization
**Class:** INDUSTRY
**Full Name:** Athira Pharma
### Status Module
#### Completion Date
**Date:** 2024-10-15

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-10-15

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-04-24

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** Fortrea Holdings, Inc.

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Athira Pharma

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Healthy Volunteers

**Keywords:**

- ATH-1105

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** SEQUENTIAL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 80

**Type:** ESTIMATED

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Part A: ATH-1105 administered once as an oral solution.

Part B: ATH-1105 administered once daily as an oral solution for 10 days.

**Intervention Names:**

- Drug: ATH-1105

**Label:** ATH-1105

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Part A: Placebo administered once as an oral solution

Part B: Placebo administered once daily as an oral solution

**Intervention Names:**

- Drug: Placebo

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- ATH-1105

**Description:** ATH-1105 in oral form. Participants will be administered ATH-1105 once in Part A and once daily for 10 days in Part B.

**Name:** ATH-1105

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Placebo

**Description:** Placebo in oral form. Participants will be administered Placebo once in Part A and once daily for 10 days in Part B.

**Name:** Placebo

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** 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

**Measure:** Incidence of Treatment-Emergent Adverse Events

**Time Frame:** Part A: Up to 7 days post-dose, Part B: Up to 7 days post final dose on day 10

**Description:** Treatment-emergent adverse events will be graded on a 1 through 5 scale, based on severity as determined by the principal investigator.

**Measure:** Severity of Treatment-Emergent Adverse Events

**Time Frame:** Part A: Up to 7 days post-dose, Part B: Up to 7 days post final dose on day 10

#### Secondary Outcomes

**Description:** AUC will be determined from all collected plasma samples from baseline through up to 48 hours post-dose.

**Measure:** Area under the plasma concentration time curve (AUC)

**Time Frame:** Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10

**Description:** Cmax will be determined from all collected plasma samples from baseline through up to 48 hours post-dose.

**Measure:** Maximum observed plasma concentration (Cmax)

**Time Frame:** Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10

**Description:** Tmax will be determined from all collected plasma samples from baseline through up to 48 hours post-dose.

**Measure:** Time to maximum observed plasma concentration (Tmax)

**Time Frame:** Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10

**Description:** t1/2 will be determined from all collected plasma samples from baseline through up to 48 hours post-dose.

**Measure:** Half-life (t1/2)

**Time Frame:** Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10

**Description:** 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

**Measure:** Amount of IMP excreted unchanged in the urine (Ae)

**Time Frame:** Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10

**Description:** Amount of IMP in the urine will be determined from all collected CSF samples from baseline through up to 48 hours post-dose

**Measure:** IMP Concentration in Cerebrospinal Fluid

**Time Frame:** Will occur at calculated maximum plasma concentration.

**Description:** Accumulation Ratio in urine will be determined from all collected urine samples from baseline through up to 48 hours post-dose

**Measure:** Accumulation Ratio (AUC) of IMP in Urine

**Time Frame:** Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10

**Description:** Accumulation Ratio in plasma will be determined from all collected plasma samples from baseline through up to 48 hours post-dose

**Measure:** Accumulation Ratio (AUC) of IMP in Plasma

**Time Frame:** Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10

### Eligibility Module

**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

**Healthy Volunteers:** True

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** info@athira.com

**Name:** Javier San Martin, MD

**Phone:** 425-620-8501

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Dallas

**Contacts:**

***Contact 1:***

- **Email:** jhande.gardiner@fortrea.com

- **Name:** Jhande Gardiner

- **Phone:** 214-647-9399

- **Role:** CONTACT

***Contact 2:***

- **Name:** Adeyemi Gbohunmi, MD, PhD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** Fortrea Clinical Research Unit Inc.

**State:** Texas

**Status:** RECRUITING

**Zip:** 75247

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Intervention Browse Module - Browse Branches

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
