NCT07518771

PA-001 Ph.1 Study in Healthy and Elderly Subjects

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: PeptiDream Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• COVID - 19

Interventions

Type	Name	Description
DRUG	PA-001	PA-001 or Placebo was infused via IV in accordance with a randomized schedule, after a fast of at least 10 hours

Timeline

• Start date: 2024-07-30
• Primary completion: 2025-06-02
• Completion: 2025-06-02
• First posted: 2026-04-09
• Last updated: 2026-04-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study