Clinical Trials Logo

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


NCT number NCT04853823
Study type Interventional
Source Hapten Sciences, Inc.
Contact Amy Longenecker, BSN RN CCRC
Phone 717-531-5136
Email [email protected]
Status Not yet recruiting
Phase Phase 1
Start date July 1, 2021
Completion date June 1, 2022

See also
  Status Clinical Trial Phase
Completed NCT00371163 - Molecular and Cellular Characterization of Spongiotic Dermatitis N/A
Completed NCT02028208 - Clinical Evaluation of Metal Panel Allergens: Mercury, Aluminum and Palladium Dose Response Study Phase 2
Completed NCT02700373 - A Phase I, Single-Center Study of PDC-APB in Healthy Volunteers Phase 1
Completed NCT03089775 - Evaluation of Safety and Efficacy of BBI-2000 in Treating and Preventing Contact Dermatitis Phase 1
Recruiting NCT04438135 - Children With Aluminium Contact Allergy: Cutaneous Exposure Study N/A
Not yet recruiting NCT02026700 - Bariederm Cream in Chronic Contact Dermatitis N/A
Completed NCT02028182 - Clinical Evaluation of Lyral® Dose Response Study Phase 2
Completed NCT00824889 - Exploratory Study of Natural Killer Cells in Human Skin N/A
Completed NCT00646867 - Effect of Tetrix on Alleviation of Burning,Itching Associated With Lesions of Contact Dermatitis N/A
Withdrawn NCT01518348 - Clinical Evaluation of T.R.U.E. TEST Panel 3.2 in Children and Adolescents Phase 3
Recruiting NCT03705182 - Prevention of Dermatitis in Epoxy Exposed Workers N/A
Recruiting NCT03198390 - Linking Epidermal Barrier Function With Anti-Oxidant Defense Mechanisms in Skin Conditions
Completed NCT00614289 - Novel Topical Treatment of Hand Dermatitis (Eczema) Phase 1
Not yet recruiting NCT04772482 - Study on Hypoallergenic Hair Dye
Completed NCT00640614 - Clinical Evaluation of T.R.U.E. TEST® : Safety and Efficacy Phase 3
Completed NCT00640250 - Clinical Evaluation of T.R.U.E. TEST® Panel 3.2 Allergens: Dose Response Phase 2