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.

Study Status:



Amyotrophic Lateral Sclerosis

Study Type:


Type of Intervention:


Intervention Name:

prosetin, placebo




Phase 1

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


Clinicaltrials.gov ID:


Neals Affiliated?


Coordinating Center Contact Information

ProJenX Clinical Trials / email hidden; JavaScript is required / (917) 423-6476

United States

Study Sponsor:


Estimated Enrollment:


Estimated Study Start Date:

02 / 26 / 2022

Estimated Study Completion Date:

07 / 01 / 2022

Posting Last Modified Date:

03 / 15 / 2022

Date Study Added to neals.org:

03 / 15 / 2022

Minimum Age:

18 Years

Maximum Age:

65 Years

Can participants use Riluzole?


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

Worldwide Clinical Trials Early Phase Services | Recruiting

Principal Investigator : Ingela Danielsson, MD, PhD, MBA

San Antonio, Texas 78217
United States