RECRUITING

A Study to Evaluate the Safety and Pharmacokinetics of Single and Multiple Doses of Prosetin in Healthy Volunteers and Participants with ALS

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The primary purpose of this study is to evaluate the safety and tolerability of prosetin in healthy volunteers and participants with ALS.

Official Title

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Dose Escalating Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending and Multiple Ascending Doses of Prosetin in Healthy Volunteers and Participants with Amyotrophic Lateral Sclerosis (ALS) with an Optional Open-Label Extended Treatment Period for ALS Participants Who Complete 14 Days of Blinded Treatment

Quick Facts

Study Start:2022-02-26
Study Completion:2026-10-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05279755

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

ProJenX Clinical Trials
CONTACT
(917) 423-6476
trials@projenx.com

Study Locations (Sites)

Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Worldwide Clinical Trials Early Phase Services
San Antonio, Texas, 78217
United States

Collaborators and Investigators

Sponsor: ProJenX

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-26
Study Completion Date2026-10-31

Study Record Updates

Study Start Date2022-02-26
Study Completion Date2026-10-31

Terms related to this study

Keywords Provided by Researchers

  • ALS
  • Amyotrophic lateral sclerosis
  • MAP4K
  • prosetin

Additional Relevant MeSH Terms

  • Amyotrophic Lateral Sclerosis