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Trial record 3 of 86 for:    PDC

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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Hapten Sciences, Inc.
ClinicalTrials.gov Identifier:
NCT02700373
First received: February 19, 2016
Last updated: May 31, 2016
Last verified: May 2016
  Purpose
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.

Condition Intervention Phase
Contact Dermatitis
Drug: PDC-APB
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase I, Single-Center, Double-Blind, Randomized, Single Ascending Dose Study of PDC-APB in Healthy Volunteers

Further study details as provided by Hapten Sciences, Inc.:

Primary Outcome Measures:
  • 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). [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Exposure to PDC-APB in study subjects. [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    The exploratory objective of the study is to document exposure of PDC-APB in study subjects by obtaining a small number of plasma samples following administration of PDC-APB by the IM route.


Estimated Enrollment: 32
Study Start Date: March 2016
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PDC-APB

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 14 days.

Drug: PDC-APB
Other Name: Active
Placebo Comparator: Placebo

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 14 days.

Drug: 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 4 dose levels (0.1, 0.4, 1, and 2 mL 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 (2 mL) is reached, or side effects that limit further dose escalation are observed.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Subjects are required to meet the following criteria in order to be included in the study:

  1. Healthy male and female subjects as determined by medical history and physical examination, from 18 to 55 years of age, inclusive
  2. 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).
  3. 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
  4. 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
  5. A body mass index (BMI) between 18 and 32 kg/m2 inclusive
  6. Able to participate and willing to give written informed consent and to comply with the study restrictions

Exclusion Criteria:

  1. History of significant contact dermatitis secondary to exposure to poison ivy, poison oak, or poison sumac, as defined in Inclusion Criteria #2 (above)
  2. 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
  3. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV), or HIV clinical laboratory test
  4. 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)
  5. 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)
  6. 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.
  7. History of significant hepatic disease or impairment, or any active symptoms of hepatic disease
  8. Presence of clinically significant gastrointestinal (GI) disorder or symptoms of active GI disease. A history of appendectomy of cholecystectomy does not exclude a subject.
  9. 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
  10. History of significant psychiatric disease, including but not limited to: bipolar disorder, depression, anxiety, panic attacks, and schizophrenia
  11. 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
  12. History of suicide attempt or report of suicidal ideation
  13. 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
  14. History of significant allergies requiring treatment with steroids (by topical or oral administration), or use in the previous year of any immunosuppressants, antihistamines, or immunotherapy
  15. Participation in an investigational drug or device study within 30 days prior to screening
  16. Donation of blood over 400 mL within 60 days prior to screening and/or hemoglobin <7 mmol/L, or any plasma donation within 7 days prior to screening
  17. Unwillingness or inability to comply with the study protocol for any reason
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02700373

Locations
United States, Tennessee
Clinical Research Solutions
Franklin, Tennessee, United States, 37064
Sponsors and Collaborators
Hapten Sciences, Inc.
Investigators
Principal Investigator: Chad S Boomershine, MD Clinical Research Solutions
  More Information

Responsible Party: Hapten Sciences, Inc.
ClinicalTrials.gov Identifier: NCT02700373     History of Changes
Other Study ID Numbers: PDC-APB-CL01 
Study First Received: February 19, 2016
Last Updated: May 31, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: Yes

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Contact
Skin Diseases
Skin Diseases, Eczematous

ClinicalTrials.gov processed this record on September 29, 2016