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

January 21, 2025 updated by: Athira Pharma

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Javier San Martin, MD
  • Phone Number: 425-620-8501
  • Email: info@athira.com

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75247
        • Fortrea Clinical Research Unit Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Drug: 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.
Placebo Comparator: Placebo

Part A: Placebo administered once as an oral solution

Part B: Placebo administered once daily as an oral solution
Drug: Placebo
Placebo in oral form. Participants will be administered Placebo once in Part A and once daily for 10 days in Part B.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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
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
Time Frame: 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.
Part A: Up to 7 days post-dose, Part B: Up to 7 days post final dose on day 10

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
AUC will be determined from all collected plasma samples from baseline through up to 48 hours post-dose.
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)
Time Frame: 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.
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)
Time Frame: 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.
Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10
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
t1/2 will be determined from all collected plasma samples from baseline through up to 48 hours post-dose.
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 (Ae)
Time Frame: 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
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
Time Frame: 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
Will occur at calculated maximum plasma concentration.
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
Accumulation Ratio in urine will be determined from all collected urine samples from baseline through up to 48 hours post-dose
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
Time Frame: 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
Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Athira Pharma

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fortrea Holdings, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 24, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 25, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 25, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 17, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 29, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ATH-1105-0101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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