NCT02700373

A Phase I, Single-Center Study of PDC-APB in Healthy Volunteers

A Phase I, Single-Center, Double-Blind, Randomized, Single Ascending Dose Study of PDC-APB in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Hapten Sciences, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 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 and tolerability of PDC-APB by intramuscular (IM) injection compared to placebo. In this First-in-Human study it is anticipated that up to 5 dose levels (2.5 mg, 10 mg, 0.125 mg, .375 mg and 1.0 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. A sentinel group of 2 subjects in each cohort will be randomized to active (1 subject) or placebo (1 subject). If the dose is tolerated in the sentinel group, the remaining 6 subjects in the cohort will be treated (5 active and 1 placebo). 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 (1 mL) is reached, or side effects that limit further dose escalation are observed.

Conditions

• Contact Dermatitis

Interventions

Type	Name	Description
DRUG	PDC-APB
DRUG	Placebo

Timeline

• Start date: 2016-03-01
• Primary completion: 2018-01-01
• Completion: 2018-01-01
• First posted: 2016-03-07
• Last updated: 2018-02-23

Locations

1 site across 1 country: United States