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Safety and Tolerability of PNT001 in Healthy Adults

NCT04096287 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2021-02-23

No results posted yet for this study

Summary

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.

Conditions

  • Healthy

Interventions

BIOLOGICAL

PNT001

PNT001 diluted in 5% dextrose

DRUG

Placebo

5% dextrose

Sponsors & Collaborators

  • Pinteon Therapeutics, Inc

    lead INDUSTRY

Principal Investigators

  • Larry D. Altstiel, MD, PhD · Pinteon Therapeutics, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-17
Primary Completion
2021-02-15
Completion
2021-02-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT04096287 on ClinicalTrials.gov