NCT04853823

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

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Hapten Sciences, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Contact Dermatitis

Interventions

Type	Name	Description
DRUG	PDC-APB	PDC-APB Intra-muscular Injection
OTHER	Placebo	Vehicle

Timeline

• Start date: 2021-11-01
• Primary completion: 2022-11-01
• Completion: 2022-12-01
• First posted: 2021-04-21
• Last updated: 2021-08-27

Regulatory

• FDA-regulated drug study