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A Safety, Tolerability, and Dermal Reactogenicity Study of PDC-APB

NCT04853823 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2021-08-27

No results posted yet for this study

Summary

This is a randomized, double-blind, placebo-controlled, single ascending dose study to assess the safety and tolerability of PDC-APB by intramuscular (IM) injection compared to placebo.

Conditions

  • Contact Dermatitis

Interventions

DRUG

PDC-APB

PDC-APB Intra-muscular Injection

OTHER

Placebo

Vehicle

Sponsors & Collaborators

  • Milton S. Hershey Medical Center

    collaborator OTHER

  • Hapten Sciences, Inc.

    lead INDUSTRY

Principal Investigators

  • James Marks, MD · Milton S. Hershey Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-11-01
Primary Completion
2022-11-01
Completion
2022-12-01
FDA Drug
Yes

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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 NCT04853823 on ClinicalTrials.gov