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

Conditions

• COVID - 19

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Jul 30, 2024

Status verified

Apr 2026

Primary completion

Jun 2, 2025

Completion

Jun 2, 2025

Study Design

Enrollment

47 participants (actual)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: SAD
  Single-dose, sequential-group of PA-001
• Experimental: MAD
  Multiple-dose, sequential-group of PA-001

Primary Outcome Measure

Incidence and severity of adverse events after single and multiple IV dosed of PA-001 in healthy subjects [ Time Frame: For approx. 8 weeks ]

Locations (1)

Find similar trials in Dallas, TX