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AP-101: Dose Level 1 for Amyotrophic Lateral Sclerosis

Phase 1
Waitlist Available
Research Sponsored by AL-S Pharma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All participants must adhere to contraception restrictions
Menopause: spontaneous amenorrhea for at least 12 months not induced by a medical conditions such as anorexia nervosa and not taking medications that induced the amenorrhea (e.g., oral contraceptives, hormones, gonadotropin releasing hormones, anti-estrogens, selective estrogen receptor modulators, or chemotherapy)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening, and at either 1 hour, 4 hours, 24 hours, 48 hours, 72 hours, or 168 hours
Awards & highlights

Study Summary

Single ascending doses of AP-101 will be administered by intravenous (IV) infusion

Eligible Conditions
  • Amyotrophic Lateral Sclerosis

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening, and at either 1 hour, 4 hours, 24 hours, 48 hours, 72 hours, or 168 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and screening, and at either 1 hour, 4 hours, 24 hours, 48 hours, 72 hours, or 168 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With One or More Non-Serious Adverse Events (AEs) or Any Serious AEs (SAEs)
Number of participants with abnormalities in vital signs, clinical laboratory assessments, physical or neurological examinations, or electrocardiograms (ECGs)
Secondary outcome measures
Area Under the Concentration Time Curve (AUC)
Maximum Observed Drug Concentration (Cmax)
Pharmacokinetic Concentrations in Cerebrospinal Fluid (CSF)
+1 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: AP-101: Dose Level 3Experimental Treatment1 Intervention
Single dose of AP-101
Group II: AP-101: Dose Level 2Experimental Treatment1 Intervention
Single dose of AP-101
Group III: AP-101: Dose Level 1Experimental Treatment1 Intervention
Single dose of AP-101

Find a Location

Who is running the clinical trial?

AL-S PharmaLead Sponsor
1 Previous Clinical Trials
63 Total Patients Enrolled
1 Trials studying Amyotrophic Lateral Sclerosis
63 Patients Enrolled for Amyotrophic Lateral Sclerosis
Study DirectorStudy DirectorAL-S Pharma SA
1,208 Previous Clinical Trials
489,677 Total Patients Enrolled
1 Trials studying Amyotrophic Lateral Sclerosis
63 Patients Enrolled for Amyotrophic Lateral Sclerosis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate AP-101 in Familial and Sporadic Amyotrophic Lateral Sclerosis (ALS)
2019. "A Study to Evaluate AP-101 in Familial and Sporadic Amyotrophic Lateral Sclerosis (ALS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03981536.
All > Lou Gehrigs Disease > Als
~3 spots leftby Apr 2025
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