A SAD and MAD Study of the Safety, Tolerability, and Pharmacokinetics of ATH-1105

NCT ID: NCT06432647

Last Updated: 2025-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-24
• Study Completion Date: 2024-11-25

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

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

ATH-1105

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

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

Group Type: EXPERIMENTAL

ATH-1105

Intervention Type: DRUG

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

Placebo

Part A: Placebo administered once as an oral solution

Part B: Placebo administered once daily as an oral solution

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

ATH-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.

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fortrea Holdings, Inc.

UNKNOWN

Sponsor Role: collaborator

Athira Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fortrea Clinical Research Unit Inc.

Dallas, Texas, United States

Countries

United States

Other Identifiers

ATH-1105-0101

Identifier Type: -

Identifier Source: org_study_id