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PA-001 Ph.1 Study in Healthy and Elderly Subjects
Sponsor: PeptiDream Inc.
Summary
This was a double blind, randomized, placebo controlled, single and multiple IV dose study conducted in 2 parts, single ascending dose and multiple ascending doses parts. The principal aim of this study was to obtain safety and tolerability data when PA-001 is administered IV as single and multiple doses to healthy subjects. This information, together with the PK data, will help establish the doses and dosing regimen suitable for future studies in patients. The study also investigated the effects of age on the PK of PA-001 prior to patient studies.
Official title: PA-001 - A Phase 1, Double Blind, Randomized, Placebo Controlled, Single and Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics in Healthy and Elderly Subjects
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
47
Start Date
2024-07-30
Completion Date
2025-06-02
Last Updated
2026-04-09
Healthy Volunteers
Yes
Conditions
Interventions
PA-001
PA-001 or Placebo was infused via IV in accordance with a randomized schedule, after a fast of at least 10 hours
Locations (1)
Fortrea Clinical Research Unit Inc.
Dallas, Texas, United States