Safety, Tolerability, and Pharmacokinetics Study of ATH-1020

NCT ID: NCT05169671

Last Updated: 2024-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-30
• Study Completion Date: 2022-09-09

Brief Summary

This Phase 1 randomized, placebo-controlled, double-blinded, first-in-human study will evaluate safety, tolerability, and pharmacokinetics of single and multiple ascending doses of ATH-1020 in healthy young and elderly subjects.

Detailed Description

This is a Phase 1 first-in-human, 2-part adaptive study. Both Part A and Part B will be performed in a randomized, placebo-controlled, and double-blind manner.

Part A - Single Ascending Dose (SAD) Part A will be a SAD study investigating multiple dose levels of ATH 1020.

Part B - Multiple Ascending Dose (MAD) Part B will be a multiple ascending dose (MAD) study investigating multiple dose levels of ATH-1020.

Subjects in Cohort B5 (4 subjects) will additionally undergo CSF sampling pre-dose on Day 4 and up to 3 post dose timepoints to evaluate ATH-1020 blood-brain-barrier penetration

Conditions

Healthy Volunteers

Study Design

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

Study Groups

ATH-1020

ATH-1020 in oral form. Participants in the single ascending dose cohort (Cohort A) will receive a single dose of ATH-1020. Participants in the multiple ascending dose cohort (Cohort B) will receive up to nine doses of ATH-1020 (up to 4 for cohort B5).

Group Type: EXPERIMENTAL

ATH-1020

Intervention Type: DRUG

ATH-1020 in oral capsule form

Placebo

Placebo in oral form. Participants in the single ascending dose cohort (Cohort A) will receive a single dose of Placebo. Participants in the multiple ascending dose cohort (Cohort B) will receive up to nine doses of placebo.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo in oral capsule form

Interventions

ATH-1020

ATH-1020 in oral capsule form

Intervention Type: DRUG

Placebo

Placebo in oral capsule form

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

All Subjects

1. Body mass index (BMI) of ≥ 18.0 and ≤ 32.0 kg/m2 at Screening, with minimum weight of 60 kg.

2. Subjects in generally good health per the investigator's discretion.

3. Male subjects and their partners must be willing to comply with the contraceptive requirements of the study.

4. Subjects must have adequate venous access.

Part A (SAD)

5. Male subjects aged 18 to 50 years at the time of signing the informed consent.

Part B (MAD)

6. Male subjects aged 18 to 50 years (Cohorts B1, B2, B3, and B5); male and post-menopausal female subjects aged 65 to 85 years (Cohort B4) at the time of signing the informed consent.

Exclusion Criteria

1. History of significant drug allergies (including to any excipients) or of anaphylactic reaction.

2. Any condition per the investigator's discretion, which while not requiring chronic medication use, is likely to require intermittent/acute therapeutic intervention.

3. Any history of seizures or loss of consciousness for an unknown reason.

4. History of or positive results of serology screening for hepatitis B, hepatitis C or human immunodeficiency virus (HIV).

5. Abnormal liver tests

6. Impaired renal function.

7. History of having taken another investigational drug within 30 days prior to Admission (Day -1).

8. Major surgery within 90 days prior to Admission (Day -1) or anticipated surgery during the study.

Part A (SAD)

9. Female subjects are not permitted.

10. Any medical condition that requires chronic medication use.

Part B (MAD)

11. A history of intermittent benzodiazepine (short-acting only) or other treatments for insomnia and anxiety are allowed, provided that the subject is able to abstain from their use during the Screening period, and from Admission until discharge from the study.

12. Reported changes in cognition and reported history of declines in everyday life in the last year.

Part B (MAD) CSF Sampling (Cohort B5)

13. Subject history of or current contraindication to lumbar puncture/spinal catheterization.

14. Clinically significant abnormalities in coagulation parameters.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Biotrial Inc.

UNKNOWN

Sponsor Role: collaborator

Alturas Analytics, Inc.

UNKNOWN

Sponsor Role: collaborator

Athira Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Biotrial, Inc.

Newark, New Jersey, United States

Countries

United States

Other Identifiers

ATH-1020-0101

Identifier Type: -

Identifier Source: org_study_id