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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 belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ screening, and at either 1 hour, 4 hours, 24 hours, 48 hours, 72 hours, or 168 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening, and at either 1 hour, 4 hours, 24 hours, 48 hours, 72 hours, or 168 hours
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 moreTrial 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.
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