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

NCT07518771 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2026-04-09

No results posted yet for this study

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

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

Sponsors & Collaborators

  • PeptiAID Inc.

    collaborator UNKNOWN

  • PeptiDream Inc.

    lead INDUSTRY

Principal Investigators

  • Masato Murakami, MD · PeptiAID Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-30
Primary Completion
2025-06-02
Completion
2025-06-02
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07518771 on ClinicalTrials.gov