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Prosetin for Amyotrophic Lateral Sclerosis (PRO-101 Trial)

Phase 1
Waitlist Available
Research Sponsored by ProJenX
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 42 days
Awards & highlights

PRO-101 Trial Summary

This trial is a Phase 1a/1b, randomized, double-blind, placebo-controlled study designed to assess the safety, tolerability, and pharmacokinetics of single and multiple ascending oral doses of prosetin administered to healthy adult subjects.

Eligible Conditions
  • Amyotrophic Lateral Sclerosis

PRO-101 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 42 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 42 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence and severity of adverse events (AEs)
Incidence of significant clinical laboratory test abnormalities
Incidence of significant electrocardiogram (ECG) abnormalities
+2 more
Secondary outcome measures
Area under the concentration versus time curve (AUC) of prosetin in CSF
Area under the concentration versus time curve (AUC) of prosetin in plasma
Cerebrospinal fluid shunts procedure
+1 more

PRO-101 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ProsetinExperimental Treatment1 Intervention
Part A: single-ascending dose; Part B: multiple doses (7 days)
Group II: PlaceboPlacebo Group1 Intervention
Part A: single-ascending dose; Part B: multiple doses (7 days)

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

ProJenXLead Sponsor
Worldwide Clinical TrialsOTHER
61 Previous Clinical Trials
14,355 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
South Carolina
What site did they apply to?
Worldwide Clinical Trials Early Phase Services
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Safety and Pharmacokinetics of Single and Multiple Doses of Prosetin in Healthy Volunteers
2022. "A Study to Evaluate the Safety and Pharmacokinetics of Single and Multiple Doses of Prosetin in Healthy Volunteers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05279755.
~10 spots leftby Apr 2025
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