A Study to Evaluate, Safety, Tolerability, and PK of AP-101 in Participants With ALS

ClinicalTrials.gov ID: NCT05039099

Open the official record

This page only displays public information reproduced from the official ClinicalTrials.gov record NCT05039099. It adds no medical advice, opinions, or eligibility judgments. The official record remains the source of truth for eligibility criteria, enrollment, and contact information.

View official ClinicalTrials.gov record → Back to search

ClinicalTrials.gov public records Last synced Nov 14, 2026, 6:48 PM EST

All trial information on this site comes from the official ClinicalTrials.gov public API (clinicaltrials.gov/api/v2), run by the U.S. National Library of Medicine. We only display that public information; we do not add opinions, endorsements, or any other intent. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of AP-101 in Participants With Sporadic or SOD1-Associated ALS

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this study is to evaluate the safety, tolerability, PK, and PD of AP-101 in participants with fALS and sALS.

Study identification

NCT ID: NCT05039099
Recruitment status: Completed
Study type: Interventional
Phase: Phase 2
Lead sponsor: AL-S Pharma; Industry
Enrollment: 73 participants

Conditions and interventions

Conditions

Amyotrophic Lateral Sclerosis

Interventions

AP-101 Drug
Placebo Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Sep 2, 2021 (Actual)
Primary completion: Aug 13, 2025 (Actual)
Completion: Aug 13, 2025 (Actual)
Last update posted: Sep 30, 2026

2021 – 2025

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
UC San Diego, ACTRI	La Jolla	California	92037	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 12 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05039099, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Sep 30, 2026 · Synced Nov 14, 2026