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COMPLETED
NCT07518771
PHASE1

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

Sponsor: PeptiDream Inc.

View on ClinicalTrials.gov

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

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

Locations (1)

Fortrea Clinical Research Unit Inc.

Dallas, Texas, United States