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

Contact Dermatitis Clinical Trial

Official title:
A Phase I, Single-Center, Double-Blind, Randomized Safety, Tolerability, and Dermal Reactogenicity Study of PDC-APB in Healthy Volunteers With a History of Contact Dermatitis Due to Poison Ivy Exposure

Clinical Trial 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.

Clinical Trial Description

This is a randomized, double-blind, placebo-controlled, single ascending dose study to assess the safety, tolerability and dermal reactogenicity in subjects shown to be sensitive to urushiol of PDC-APB by intramuscular (IM) injection compared to placebo. In this study, it is anticipated that up to 4 dose levels (5.0 mg, 10 mg, 15 mg, and 20 mg PDC-APB) will be studied in sequential cohorts. Each cohort will enroll 8 subjects, 6 subjects randomized to active treatment and 2 randomized to placebo, in a double-blind manner. Safety will be assessed in each cohort before starting treatment at the next higher dose level. If the study treatment is tolerated and there are no findings that necessitate stopping the study, the next cohort will be treated at the next higher dose level, in the same manner. This process will continue until the highest intended dose is reached, or side effects that limit further dose escalation are observed. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04853823
Study type Interventional
Source Hapten Sciences, Inc.
Contact Amy Longenecker, BSN RN CCRC
Phone 717-531-5136
Email alongenecker@pennstatehealth.psu.edu
Status Not yet recruiting
Phase Phase 1
Start date November 1, 2021
Completion date December 1, 2022
View Details
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