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:
Recruiting
Disease:
Amyotrophic Lateral Sclerosis
Study Type:
Interventional
Type of Intervention:
Drug
Intervention Name:
prosetin, placebo
Placebo:
Yes
Phase:
Phase 1
Study Chair(s)/Principal Investigator(s):
N/A
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
ProJenX Clinical Trials / email hidden; JavaScript is required / (917) 423-6476
United States
Study Sponsor:
ProJenX
Estimated Enrollment:
32
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?
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
Worldwide Clinical Trials Early Phase Services | Recruiting
Principal Investigator : Ingela Danielsson, MD, PhD, MBA
San Antonio, Texas
78217
United States