Contact DermatitisPhase 1NCT04853823
A Safety, Tolerability, and Dermal Reactogenicity Study of PDC-APB
A Phase 1 study testing PDC-APB in people with Contact Dermatitis, run by Hapten Sciences, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Contact Dermatitis
- What is being tested?
- PDC-APB
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2021to 1 Dec 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- History of asthma, including subjects with asthma who require acute or maintenance inhaled or oral steroid use for control of symptoms, as well as subjects with intermittent asthma who do not require corticosteroids.
- History of any acute or chronic skin condition (except acne or contact dermatitis as noted in Inclusion Criteria #2) or the presence of any rashes on the back at screening or baseline that would interfere with patch assessments.
- Presence of tattoos or skin disease at the intended patch application sites.
- Participation in an investigational drug or device study within 30 days prior to screening.
- Unwillingness or inability to comply with the study protocol for any reason.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
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.
Read the 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
- Being tested
- PDC-APB, Placebo
- Medical subject headings
- Dermatitis, Contact
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PDC-APBDrug
Also called Active
PDC-APB Intra-muscular Injection
PlaceboOther
Also called Vehicle
Vehicle
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 Weeks
Secondary outcomes (1)
Urushiol Sensitivity [scored +/-, 0-4]
Secondary assessments will evaluate the effect of PDC-APB injection on urushiol sensitivity (scored +/-, 0-4). Local reactogenicity to the second urushiol patch applied 6 weeks after IP injection will be compared to the reactogenicity scores following application of the first patch 6 weeks prior to injection of IP.
Measured: 15 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start1 Nov 2021 (estimated)
- Primary completion1 Nov 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contact DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hapten Sciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Milton S. Hershey Medical Center
- Responsible party
- Sponsor
- Investigators
- James Marks, MD, Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04853823
- Sponsor's protocol ID
- PDC-APB CL-04
- Status last verified
- Apr 2021
- First submitted
- 13 Apr 2021
- Last updated
- 27 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04853823
- Acronym / sponsor ID
- PDC-APB CL-04
- Conditions
- Contact Dermatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Hapten Sciences, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Milton S. Hershey Medical Center
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 21 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PDC-APB | Experimental | Drug: PDC-APBStudy 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. |
| Vehicle | Placebo comparator | Other: PlaceboStudy 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PDC-APBAlso: ActivePDC-APB Intra-muscular Injection | Drug | PDC-APB |
| PlaceboAlso: VehicleVehicle | Other | Vehicle |
Primary outcome
Incidence of Adverse Events [Safety and tolerability]
Time frame: 24 Weeks
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.
1 secondary outcome
Urushiol Sensitivity [scored +/-, 0-4]
Time frame: 15 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Marks, MD principal investigator
Milton S. Hershey Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PDC-APB in people with Contact Dermatitis, run by Hapten Sciences, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amy Longenecker, BSN RN CCRC (717-531-5136, alongenecker@pennstatehealth.psu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events [Safety and tolerability] (time frame: 24 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2021.