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

NCT04853823 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: PDC-APB CL-04
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events [Safety and tolerability]

  The Primary outcome measure for this study will be the overall safety profile observed during the post-treatment observation period in the study population. AEs will be classified by organ class using the coding system and by severity (Grades 1-4, Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials). The primary objective of the study is to assess the safety and tolerability of PDC-APB following single doses administered intramuscularly to healthy subjects between 18 and 65 years of age.

  24 Weeks

Secondary Outcomes (1)

• Urushiol Sensitivity [scored +/-, 0-4]

  15 Weeks

Study Arms (2)

PDC-APB

EXPERIMENTAL

Study duration for each subject is approximately 15 weeks (105 days) for Screening including patch testing, Treatment, and the initial 30-day post-treatment periods. Approximately 6 weeks after treatment, subjects will receive a second patch test. In addition, each subject will be followed from T1 for 6 months by monthly telephone follow-up to monitor adverse events. Subjects in Cohorts 2, 3 and 4 and, if applicable, additional cohorts, will not be dosed until all subjects from the prior cohort have completed the assessments after IP dosing and the Safety Review Committee has reviewed the results prior to Day T14. All subjects will be followed for 6 months after IP dosing for safety assessments, which will be carried out at monthly intervals via telephone.

Drug: PDC-APB

Vehicle

PLACEBO COMPARATOR

Study duration for each subject is approximately 15 weeks (105 days) for Screening including patch testing, Treatment, and the initial 30-day post-treatment periods. Approximately 6 weeks after treatment, subjects will receive a second patch test. In addition, each subject will be followed from T1 for 6 months by monthly telephone follow-up to monitor adverse events. Subjects in Cohorts 2, 3 and 4 and, if applicable, additional cohorts, will not be dosed until all subjects from the prior cohort have completed the assessments after IP dosing and the Safety Review Committee has reviewed the results prior to Day T14. All subjects will be followed for 6 months after IP dosing for safety assessments, which will be carried out at monthly intervals via telephone.

Other: Placebo

Interventions

PDC-APB DRUG

PDC-APB Intra-muscular Injection

Also known as: Active

PDC-APB

Placebo OTHER

Vehicle

Also known as: Vehicle

Vehicle

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male and female subjects, as determined by medical history and physical examination, from 18 to 65 years of age, inclusive.
• Documented history of urushiol exposure on the Allergic Contact Dermatitis Questionnaire.
• For female subjects: Surgically sterile or menopausal (at least 1-year absence of vaginal bleeding or spotting). Females of childbearing age/potential may be included provided they are using medically acceptable methods of birth control for 1 month prior to and for the duration of the study and 3 months thereafter. Dual methods, for example, a hormonal method used with a barrier method, must be used.
• For male subjects and their partners of childbearing potential: Willing to use 2 methods of contraception, 1 of which must be a barrier method, for the duration of the study and 3 months after the last dose of IP, and agree to not donate sperm for 3 months after the last dose of IP.
• Has sufficient normal skin area on the back to accommodate two patch applications (no scarring, acne, excessive hair, or tattooing)
• Able to participate and willing to give written informed consent and to comply with the study restrictions.

You may not qualify if:

• History of alcohol or drug abuse within the past 24 months or related concerns of the investigator.
• Positive human immunodeficiency (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) clinical laboratory test.
• Administration of, or need for, any prescription drug within 30 days, or over-the-counter (OTC) drugs on a regular basis. Hormonal contraceptive drugs, hormone replacement therapy (stable dose for at least 3 months), acetaminophen and ibuprofen ≤ 1 g/day, blood pressure and cholesterol medication, anti-acids, and multivitamins are permitted.
• Any screening laboratory evaluation for liver function outside the laboratory reference range or any other laboratory value \> 1.5 × the reference range not approved in writing by the Medical Monitor.
• Body temperature \> 37.5°C (99.5°F), systolic blood pressure (SBP) \< 90 or \> 139 mmHg, diastolic blood pressure (DBP) \< 50 or \> 89 mmHg, or presence of any other abnormal vital signs measurement considered by the Investigator to be clinically significant.
• History of clinically significant renal or urinary disease or active symptoms of renal or urinary disease. A history of renal stones or urinary tract infections does not exclude a subject.
• History of clinically significant hepatic disease or impairment, or any active symptoms of hepatic disease.
• Presence of clinically significant gastrointestinal (GI) disorder or symptoms of active GI disease. A history of appendectomy or cholecystectomy does not exclude a subject.
• History of significant cardiovascular disease, congestive heart failure, stroke, angina, arrhythmias, or symptoms or signs of active cardiovascular disease, or a clinically significant abnormality on the screening ECG considered by the Sponsor and the Investigator to be unacceptable. Hypertension and hypercholesterolemia if well-controlled are not excluded.
• History of clinically significant psychiatric disease, including but not limited to bipolar disorder, depression, anxiety, panic attacks, and schizophrenia.
• History or symptoms of clinically significant central nervous system disease, including but not limited to transient ischemic attack, stroke, seizure disorder, history of loss of consciousness or head trauma, or behavioral disturbances.
• History of suicide attempt or report of suicidal ideation.
• Concomitant disease or any organ system condition or abnormality that could pose an unacceptable risk to the subject in this study, in the opinion of the Investigator, based on possible interference with absorption, distribution, metabolism, or elimination of the IP or possible effect of the IP on the condition or abnormality.
• History of clinically significant allergies requiring treatment with steroids (by topical or oral administration) in the previous 90 days, use in the previous year of any immunosuppressants or immunotherapy, or use of oral or topical antihistamines in the previous 30 days.
• Known or suspected allergy or cutaneous sensitivity to any product components, including sesame or sesame oil, benzyl alcohol, or ethanol.

Sponsors & Collaborators

• Hapten Sciences, Inc.: lead
• Milton S. Hershey Medical Center: collaborator

MeSH Terms

Conditions

Dermatitis, Contact

Interventions

Exercise

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• James Marks, MD

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy Longenecker, BSN RN CCRC

CONTACT

717-531-5136; alongenecker@pennstatehealth.psu.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 21, 2021
• Study Start: November 1, 2021
• Primary Completion: November 1, 2022
• Study Completion: December 1, 2022
• Last Updated: August 27, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share