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

Amyotrophic Lateral Sclerosis Clinical Trial

— PRO-101  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05279755
• Other study ID #: 5027513
• Status: Recruiting
• Phase: Phase 1
• Start date: February 26, 2022
• Est. completion date: July 2022

Study information

• Verified date: March 2022
• Source: ProJenX
• Contact: ProJenX Clinical Trials
• Phone: (917) 423-6476
• Email: trials[@]projenx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: July 2022
• Est. primary completion date: May 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease

Intervention

Drug:
• prosetin
oral solution
• placebo
oral solution

Locations

Country	Name	City	State
United States	Worldwide Clinical Trials Early Phase Services	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
ProJenX	Worldwide Clinical Trials

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of adverse events (AEs)		Up to 42 days
Primary	Incidence of significant clinical laboratory test abnormalities		Up to 42 days
Primary	Incidence of significant vital signs abnormalities		Up to 42 days
Primary	Incidence of significant electrocardiogram (ECG) abnormalities		Up to 42 days
Primary	Incidence of significant physical, neurological, and/or ophthalmic examination abnormalities		Up to 42 days
Secondary	Maximum concentration (Cmax) of prosetin in plasma		Up to 42 days
Secondary	Maximum concentration (Cmax) of prosetin in cerebrospinal fluid (CSF)		Up to 42 days
Secondary	Area under the concentration versus time curve (AUC) of prosetin in plasma		Up to 42 days
Secondary	Area under the concentration versus time curve (AUC) of prosetin in CSF		Up to 42 days