Safety, Tolerability, and Pharmacokinetics Study of ATH-1020

NCT05169671 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: ATH-1020-0101
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Pharmacokinetics; HGF/MET

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

  Safety and tolerability of single or multiple ascending doses of ATH-1020 as measured by vital signs and clinical laboratory measurements.

  Up to 12 days post initial dosing (Part A); Up to 19 days post initial dosing (Part B)

Secondary Outcomes (6)

• Maximum observed plasma concentration (Cmax)

  Cmax will be determined from all collected plasma samples from baseline through up to 48 hours post-dose.

• Time to maximum observed plasma concentration (Tmax)

  Samples collected pre-dose and at predetermined timepoints within 48 hours post-dose.

• Plasma concentration at the end of the dosing interval (Ctrough)

  Samples collected pre-dose and at predetermined timepoints within 24 hours post-dose.

• Area under the plasma concentration time curve (AUC)

  Samples collected pre-dose and at predetermined timepoints within 48 hours post-dose.

• Half-life (t1/2)

  Samples collected pre-dose and at predetermined timepoints within 48 hours post-dose.

Study Arms (2)

ATH-1020

EXPERIMENTAL

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).

Drug: ATH-1020

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

ATH-1020 DRUG

ATH-1020 in oral capsule form

ATH-1020

Placebo DRUG

Placebo in oral capsule form

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Gender Eligibility Details: Part A and Part B cohorts B1-3 and B5-7: Healthy young male subjects, aged 18-50 years Part B cohort B4: Healthy male subjects and female subjects with non-childbearing potential aged 65 to 85 years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All Subjects
• Body mass index (BMI) of ≥ 18.0 and ≤ 32.0 kg/m2 at Screening, with minimum weight of 60 kg.
• Subjects in generally good health per the investigator's discretion.
• Male subjects and their partners must be willing to comply with the contraceptive requirements of the study.
• Subjects must have adequate venous access.
• Part A (SAD)
• Male subjects aged 18 to 50 years at the time of signing the informed consent.
• Part B (MAD)
• 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.

You may not qualify if:

• History of significant drug allergies (including to any excipients) or of anaphylactic reaction.
• Any condition per the investigator's discretion, which while not requiring chronic medication use, is likely to require intermittent/acute therapeutic intervention.
• Any history of seizures or loss of consciousness for an unknown reason.
• History of or positive results of serology screening for hepatitis B, hepatitis C or human immunodeficiency virus (HIV).
• Abnormal liver tests
• Impaired renal function.
• History of having taken another investigational drug within 30 days prior to Admission (Day -1).
• Major surgery within 90 days prior to Admission (Day -1) or anticipated surgery during the study.
• Part A (SAD)
• Female subjects are not permitted.
• Any medical condition that requires chronic medication use.
• Part B (MAD)
• 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.
• Reported changes in cognition and reported history of declines in everyday life in the last year.
• Part B (MAD) CSF Sampling (Cohort B5)

Sponsors & Collaborators

• Athira Pharma: lead
• Biotrial Inc.: collaborator
• Alturas Analytics, Inc.: collaborator

Study Sites (1)

Biotrial, Inc.

Newark, New Jersey, 07103, United States

Location

Study Design

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

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: December 27, 2021
• Study Start: March 30, 2022
• Primary Completion: September 9, 2022
• Study Completion: September 9, 2022
• Last Updated: April 8, 2024

Record last verified: 2024-04

Locations

US (1)