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Completed Phase 1 Interventional Accepts healthy volunteers

Safety and Tolerability of PNT001 in Healthy Adults

ClinicalTrials.gov ID: NCT04096287

Public ClinicalTrials.gov record NCT04096287. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 6, 2026, 5:33 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single-Ascending-Dose Trial to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of Intravenous PNT001 in Healthy Volunteers

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This first in human study is a multi-center, randomized, double-blind, placebo-controlled single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of intravenous PNT001 in healthy adult participants.

Study identification

NCT ID
NCT04096287
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Pinteon Therapeutics, Inc
Industry
Enrollment
49 participants

Conditions and interventions

Conditions

Interventions

Biological · Drug

Eligibility (public fields only)

Age range
21 Years to 65 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 16, 2019
Primary completion
Feb 14, 2021
Completion
Feb 14, 2021
Last update posted
Feb 22, 2021

2019 – 2021

United States locations

U.S. sites
4
U.S. states
4
U.S. cities
4
Facility City State ZIP Site status
Woodland Research Northwest Rogers Arkansas 72758
Pacific Research Network, Inc. San Diego California 92103
Hassman Research Institute Marlton New Jersey 08053
Worldwide Clinical Trials San Antonio Texas 78217

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04096287, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 22, 2021 · Synced Sep 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04096287 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →