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

NCT02700373 | Completed Phase 1 DMC

• 1 other identifier: PDC-APB-CL01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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)

• 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 (Grade 1-4).

  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 55 years of age.

  24 Weeks

Secondary Outcomes (1)

• Exposure to PDC-APB in study subjects.

  28 days

Study Arms (2)

PDC-APB

EXPERIMENTAL

PDC-APB Intra-Muscular (IM) One single dose will be administered with an inpatient direct observational period of 24 hours following the dose, followed by outpatient follow-up for a total of 28 days. After Day 28, the subject will continue to be followed up for study related AE assessments thru Week 24.

Drug: PDC-APB

Placebo

PLACEBO COMPARATOR

Placebo One single dose will be administered with an inpatient direct observational period of 24 hours following the dose, followed by outpatient follow-up for a total of 28 days. After Day 28, the subject will continue to be followed up for study related AE assessments thru Week 24.

Drug: Placebo

Interventions

PDC-APB DRUG

Also known as: Active

PDC-APB

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects are required to meet the following criteria in order to be included in the study:
• Healthy male and female subjects as determined by medical history and physical examination, from 18 to 55 years of age, inclusive
• History of previous exposure to poison ivy, oak, or sumac without development of significant contact dermatitis. Significant contact dermatitis is defined as a skin reaction that covered more than 10% of body surface area by the subject's estimation, occurred on the face or genitals, was rated by the subject as moderate or severe, or required treatment with topical, oral, or injectable (systemic) steroids for resolution of symptoms. History of exposure will be documented using the Allergic Contact Dermatitis Questionnaire (Appendix 1).
• For female subjects: Surgically sterile or menopausal (at least 1 year absence of vaginal bleeding or spotting) and as confirmed by follicle-stimulating hormone (FSH) ≥ 40 mIU/mL. Females of childbearing age/potential may be included provided that they are using medically acceptable methods of birth control for 1 month prior to and for the duration of the study and for 3 months thereafter. Dual methods must be used, for example a hormonal method used with a barrier method.
• For male subjects and their partners of childbearing potential: Willing to use two methods of contraception, one of which must be a barrier method, for the duration of the study and for 3 months after the last dose of study drug, and agreed not to donate sperm for 3 months after the last dose of study drug
• A body mass index (BMI) between 18 and 32 kg/m2 inclusive
• Able to participate and willing to give written informed consent and to comply with the study restrictions

You may not qualify if:

• Positive breath test for alcohol or urine test for drugs of abuse as per local standard at screening, or a history of alcohol or drug abuse within the past 24 months
• Positive hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV), or HIV clinical laboratory test
• Administration of, or need for, any prescription drug within 21 days, or over-the-counter drugs (except acetaminophen and ibuprofen ≤ 1 g/day or multivitamins, which are permitted)
• Any screening laboratory evaluation outside the laboratory reference range that is judged by the investigator to be clinically significant (including hepatic and renal panels, complete blood count, chemistry panel, and urinalysis)
• History of significant renal or urinary disease or active symptoms of renal or urinary disease. A history of renal stones or of urinary tract infections does not exclude a subject.
• History of 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 of cholecystectomy does not exclude a subject.
• History of significant cardiovascular disease, such as hypertension requiring drug therapy, congestive heart failure, stroke, angina, arrhythmias, or symptoms or signs of active cardiovascular disease, or a clinically significant abnormality on the screening ECG that the Sponsor considers unacceptable
• History of significant psychiatric disease, including but not limited to: bipolar disorder, depression, anxiety, panic attacks, and schizophrenia
• History or symptoms of significant central nervous system (CNS) disease, including but not limited to: transient ischemic attack (TIA), 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 study drug or possible effect of the study drug on the condition or abnormality
• History of significant allergies requiring treatment with steroids (by topical or oral administration), or use in the previous year of any immunosuppressants or immunotherapy, or use of oral or topical antihistamines in the previous 14 days
• Known or suspected allergy or cutaneous sensitivity to any product components, including sesame or sesame oil, benzyl alcohol, or ethanol
• History of asthma, including subjects with asthma who require acute or maintenance inhaled or oral steroid use for control of symptoms, as well as subject with intermittent asthma who do not require corticosteroids.

Sponsors & Collaborators

• Hapten Sciences, Inc.: lead

Study Sites (1)

Clinical Research Solutions

Franklin, Tennessee, 37064, United States

Location

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

• Chad S Boomershine, MD

  Clinical Research Solutions

  PRINCIPAL INVESTIGATOR

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: February 19, 2016
• First Posted: March 7, 2016
• Study Start: March 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: February 23, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)