A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating Study to Evaluate the Safety and Pharmacokinetics of Single Ascending and Multiple Doses of Prosetin in Healthy Volunteers

Study Purpose:

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.

Disease:

Healthy Volunteer, Healthy Volunteer with a Family History of ALS

Study Type:

Interventional Trial

Study Category:

Drug Trial

Study Status:

Enrolling

Phase:

Phase I

Study Chair(s)/Principal Investigator(s):

Clinicaltrials.gov ID (11 digit #):

NCT05279755

Neals Affiliated?

No

Coordinating Center Contact Information


ProJenX Clinical Trials / .(JavaScript must be enabled to view this email address) / 917-423-6476
.(JavaScript must be enabled to view this email address) United States

Full Study Summary:

Study Sponsor:

ProJenX

Participant Duration:

Estimated Enrollment:

32

Estimated Study Start Date:

02/26/2022

Estimated Study Completion Date:

07/31/2022

Posting Last Modified Date:

05/13/2022

Date Study Added to alsconsortium.org:

05/13/2022
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    18

    Maximum Age:

    65

    Time since Symptom Onset:

    Time since Diagnosis:

    Can participants use Riluzole?

    Yes


    Key Inclusion Criteria:

    • Adults between 18 and 65 years of age, inclusive
    • BMI within 18.0 to 32.0 kg/m2, inclusive
    • In good health, in the opinion of the Investigator, as determined by a physical examination, vital signs, 12-lead ECG, and clinical laboratory assessments
    • Females of childbearing potential must agree to an approved method of contraception

    Key Exclusion Criteria:

    • History or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, musculoskeletal, neurological, or psychiatric disorder
    • Any episodes of vertigo in the previous 12 months prior to screening or any medical history of seizures
    • Active autoimmune conditions such as systemic lupus erythematosus
    • A diagnosis of cancer or evidence of continued disease within five years before screening

  • Site Contact Information

    Worldwide Clinical Trials Early Phase Services
    San Antonio, Texas 78217
    United States