Prosetin for ALS
(PRO-101 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests prosetin, a new treatment for amyotrophic lateral sclerosis (ALS), a disease affecting nerves and muscles. The main goal is to assess the safety and tolerability of prosetin in both healthy volunteers and people with ALS. The trial includes several parts, administering single and multiple doses of prosetin to different groups. People with ALS, diagnosed using specific criteria and able to manage daily tasks like swallowing liquids, might be suitable candidates. Participants must not have other significant health issues or have participated in other drug trials recently. As a Phase 1 trial, this research focuses on understanding how prosetin works in people, offering participants the chance to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
If you are taking riluzole or other standard ALS treatments, you must be on a stable dose for at least 30 days before the trial and continue it throughout the study. The protocol does not specify about other medications, so it's best to discuss with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that prosetin was safe in earlier studies. Healthy volunteers tolerated both single and multiple doses well compared to a placebo, with no major safety issues reported. Prosetin is also considered safe for long-term use, suggesting suitability for extended treatment. These results support further testing in people with ALS. However, since this trial is in an early phase, it will focus more on assessing safety and tolerance.12345
Why do researchers think this study treatment might be promising for ALS?
Prosetin is unique because it offers a fresh approach to treating ALS (amyotrophic lateral sclerosis). Unlike traditional treatments like riluzole and edaravone, which primarily focus on slowing disease progression, prosetin targets a novel mechanism. It acts on the cellular stress response system, aiming to protect neurons from the damage caused by ALS. Researchers are excited about prosetin's potential to not only slow down the disease but also improve the quality of life for patients by preserving motor function longer.
What evidence suggests that prosetin might be an effective treatment for ALS?
Research suggests that prosetin might help treat ALS by targeting a key process involved in the disease. ALS, or amyotrophic lateral sclerosis, causes nerve cells to break down, leading to loss of muscle control. Prosetin aims to protect these nerve cells from damage. Early studies have shown that prosetin can reduce ALS symptoms and protect nerve cells. In this trial, participants with ALS will receive either multiple ascending doses of prosetin or a placebo to evaluate its effectiveness. Although more research is needed, these findings offer hope that prosetin could be a promising treatment for people with ALS.35678
Are You a Good Fit for This Trial?
Adults aged 18-65 with a BMI of 18.0 to 32.0, in good health as determined by medical exams, and willing to use contraception can join this trial. It's for healthy volunteers and those with ALS.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive multiple ascending doses of prosetin or placebo for 14 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension
Participants with ALS may opt into continuation of treatment with prosetin for up to 52 weeks
What Are the Treatments Tested in This Trial?
Interventions
- placebo
- prosetin
Trial Overview
The study is testing the safety of Prosetin, a potential treatment for ALS. Participants will receive either Prosetin or a placebo to compare effects.
How Is the Trial Designed?
7
Treatment groups
Experimental Treatment
Placebo Group
Participants will be administered a once-daily dose of prosetin for up to 52 weeks.
Participants will be administered a once-daily dose of prosetin at multiple ascending dose levels for 14 days.
Healthy volunteers were administered a once-daily dose of prosetin at 0.06 or 0.10 mg/kg for 14 days.
Healthy volunteers were administered a single dose of prosetin oral solution at 0.03, 0.06, 0.12, or 0.24 mg/kg.
Healthy volunteers were administered a single dose of prosetin-matched placebo oral solution.
Healthy volunteers were administered a once-daily dose of prosetin-matched placebo for 14 days.
Participants are administered a once-daily dose of prosetin-matched placebo for 14 days.
Find a Clinic Near You
Who Is Running the Clinical Trial?
ProJenX
Lead Sponsor
Congressionally Directed Medical Research Programs
Collaborator
Worldwide Clinical Trials
Collaborator
Citations
NCT05279755 | A Study to Evaluate the Safety and ...
The primary purpose of this study is to evaluate the safety and tolerability of prosetin in healthy volunteers and participants with ALS. Detailed Description.
ProJenX Announces Removal of Partial Clinical Hold for ...
The United States Food and Drug Administration (FDA) has removed a partial clinical hold on Study PRO-101, a hybrid Phase 1 clinical trial evaluating prosetin.
Genetic and Mechanistic Insights Inform Amyotrophic ...
Real-world evidence of riluzole effectiveness in treating amyotrophic lateral sclerosis. Amyotroph Lateral Scler Frontotemporal Degener.
4.
neurologylive.com
neurologylive.com/view/fda-removes-partial-clinical-hold-phase-1-trial-map4k-inhibitor-prosetin-alsFDA Removes Partial Clinical Hold on Phase 1 Trial ...
The phase 1 study, dubbed PRO-101, assesses the safety, tolerability, pharmacokinetics, and pharmacodynamics of prosetin in both patients with ALS and healthy ...
Phase 1 trial of prosetin to create digital twins of ALS patients
A treatment goal is to ease ALS symptoms. The AI-based model will draw on data collected from patients at trial entry to forecast outcomes for ...
6.
projenx.com
projenx.com/projenx-receives-european-authorization-for-first-study-of-prosetin-in-people-living-with-als/ProJenX Receives European Authorization for First Study ...
Prosetin is a selective, oral, brain-penetrant, MAP4K inhibitor developed by ProJenX co-founders at Columbia University for the treatment of ALS ...
2022 Amyotrophic Lateral Sclerosis Highlight
It should be noted that prosetin is orally bioavailable, metabolically stable, CNS-penetrant, and well-tolerated in long-term administration ...
NCT05279755 | A Study to Evaluate the Safety and ...
The primary purpose of this study is to evaluate the safety and tolerability of prosetin in healthy volunteers and participants with ALS. ... PRO-101 is a four- ...
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