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

NCT05279755 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2026-04-27

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

prosetin

oral solution

DRUG

placebo

oral solution

Sponsors & Collaborators

  • Congressionally Directed Medical Research Programs

    collaborator FED

  • ProJenX

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-26
Primary Completion
2026-06-30
Completion
2026-10-31
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Netherlands

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05279755 on ClinicalTrials.gov