We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Evaluate the Safety and Pharmacokinetics of Single and Multiple Doses of Prosetin in Healthy Volunteers (PRO-101)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05279755
Recruitment Status : Recruiting
First Posted : March 15, 2022
Last Update Posted : March 15, 2022
Sponsor:
Collaborator:
Worldwide Clinical Trials
Information provided by (Responsible Party):
ProJenX

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Drug: prosetin Drug: placebo Phase 1

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : February 26, 2022
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Prosetin
Part A: single-ascending dose; Part B: multiple doses (7 days)
 Drug: prosetin
oral solution
Placebo Comparator: Placebo
Part A: single-ascending dose; Part B: multiple doses (7 days)
 Drug: placebo
oral solution


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Incidence and severity of adverse events (AEs) [ Time Frame: Up to 42 days ]
  2. Incidence of significant clinical laboratory test abnormalities [ Time Frame: Up to 42 days ]
  3. Incidence of significant vital signs abnormalities [ Time Frame: Up to 42 days ]
  4. Incidence of significant electrocardiogram (ECG) abnormalities [ Time Frame: Up to 42 days ]
  5. Incidence of significant physical, neurological, and/or ophthalmic examination abnormalities [ Time Frame: Up to 42 days ]

Secondary Outcome Measures :
  1. Maximum concentration (Cmax) of prosetin in plasma [ Time Frame: Up to 42 days ]
  2. Maximum concentration (Cmax) of prosetin in cerebrospinal fluid (CSF) [ Time Frame: Up to 42 days ]
  3. Area under the concentration versus time curve (AUC) of prosetin in plasma [ Time Frame: Up to 42 days ]
  4. Area under the concentration versus time curve (AUC) of prosetin in CSF [ Time Frame: Up to 42 days ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05279755


Contacts
Layout table for location contacts
Contact: ProJenX Clinical Trials (917) 423-6476 trials@projenx.com

Locations
Layout table for location information
United States, Texas
Worldwide Clinical Trials Early Phase Services Recruiting
San Antonio, Texas, United States, 78217
Principal Investigator: Ingela Danielsson, MD, PhD, MBA         
Sponsors and Collaborators
ProJenX
Worldwide Clinical Trials
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: ProJenX
ClinicalTrials.gov Identifier: NCT05279755    
Other Study ID Numbers: 5027513
First Posted: March 15, 2022    Key Record Dates
Last Update Posted: March 15, 2022
Last Verified: March 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
 Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases