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

NCT06432647 | Completed Phase 1 FDA Drug

• 1 other identifier: ATH-1105-0101
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

ATH-1105

Outcome Measures

Primary Outcomes (2)

• Incidence of Treatment-Emergent Adverse Events

  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

  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 Outcomes (8)

• 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

• 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

• 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

• Half-life (t1/2)

  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)

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

Study Arms (2)

ATH-1105

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Part A: Placebo administered once as an oral solution Part B: Placebo administered once daily as an oral solution

Drug: Placebo

Interventions

ATH-1105 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.

ATH-1105

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• QTcF \>450 ms in males or \>470 ms in females
• QRS duration \>110 ms
• PR interval \>220 ms
• Findings which would make QTc measurements difficult or QTc data uninterpretable.
• 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.

Sponsors & Collaborators

• Athira Pharma: lead
• Fortrea Holdings, Inc.: collaborator

Study Sites (1)

Fortrea Clinical Research Unit Inc.

Dallas, Texas, 75247, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: May 29, 2024
• Study Start: April 24, 2024
• Primary Completion: November 25, 2024
• Study Completion: November 25, 2024
• Last Updated: January 23, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)