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

Phase 1

Recruiting

• Conditions: Healthy Volunteers
• Interventions: Drug: ATH-1105; Drug: Placebo

• Registration Number: NCT06432647
• Lead Sponsor: Athira Pharma

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.

Study Timeline

• Study Start: 2024-04-24
• Status Verified: 2024-05
• Study First Submitted: 2024-05-17
• Study First Submitted QC: 2024-05-22
• Last Update Submitted: 2024-05-22
• Study First Posted: 2024-05-29
• Last Update Posted: 2024-05-29
• Primary Completion: 2024-10-15
• Study Completion: 2024-10-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
ATH-1105	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.
Placebo	Placebo	Part A: Placebo administered once as an oral solution Part B: Placebo administered once daily as an oral solution

Primary Outcome Measures

Name	Time	Method
Severity of Treatment-Emergent Adverse Events	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.
Incidence of Treatment-Emergent Adverse Events	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

Secondary Outcome Measures

Name	Time	Method
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	Tmax will be determined from all collected plasma samples from baseline through up to 48 hours post-dose.
IMP Concentration in Cerebrospinal Fluid	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
Accumulation Ratio (AUC) of IMP in Urine	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
Half-life (t1/2)	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.
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	Cmax will be determined from all collected plasma samples from baseline through up to 48 hours post-dose.
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	AUC will be determined from all collected plasma samples from baseline through up to 48 hours post-dose.
Accumulation Ratio (AUC) of IMP in Plasma	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
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	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

Trial Locations

Locations (1)

Fortrea Clinical Research Unit Inc.; 🇺🇸 Dallas, Texas, United States