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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06432647
• Other study ID #: ATH-1105-0101
• Status: Recruiting
• Phase: Phase 1
• Start date: April 24, 2024
• Est. completion date: October 15, 2024

Study information

• Verified date: May 2024
• Source: Athira Pharma
• Contact: Javier San Martin, MD
• Phone: 425-620-8501
• Email: info[@]athira.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 15, 2024
• Est. primary completion date: October 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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

Locations

Country	Name	City	State
United States	Fortrea Clinical Research Unit Inc.	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Athira Pharma	Fortrea Holdings, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Area under the plasma concentration time curve (AUC)	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
Secondary	Maximum observed plasma concentration (Cmax)	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
Secondary	Time to maximum observed plasma concentration (Tmax)	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
Secondary	Half-life (t1/2)	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
Secondary	Amount of IMP excreted unchanged in the urine (Ae)	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
Secondary	IMP Concentration in Cerebrospinal Fluid	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.
Secondary	Accumulation Ratio (AUC) of IMP in Urine	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
Secondary	Accumulation Ratio (AUC) of IMP in Plasma	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