Contact DermatitisPhase 1NCT02700373
A Phase I, Single-Center Study of PDC-APB in Healthy Volunteers
A Phase 1 study testing PDC-APB in people with Contact Dermatitis, run by Hapten Sciences, Inc. at 1 site in United States.
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 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Contact Dermatitis
- What is being tested?
- PDC-APB
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Jan 2018
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- History of significant contact dermatitis secondary to exposure to poison ivy, poison oak, or poison sumac, as defined in Inclusion Criteria #2 (above)
- 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.
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- 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.
- History of any acute or chronic skin condition (except contact dermatitis as noted in Inclusion Criteria #2) or the presence of any rashes at screening or baseline.
- Participation in an investigational drug or device study within 30 days prior to screening
- 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
- Unwillingness or inability to comply with the study protocol for any reason
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Research Solutions
Franklin, Tennessee, 37064
About this study
Official title: A Phase I, Single-Center, Double-Blind, Randomized, Single Ascending Dose Study of PDC-APB in Healthy Volunteers
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 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
- 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
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 Weeks
Secondary outcomes (1)
Exposure to PDC-APB in study subjects.
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.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionJan 2018
- Study completionJan 2018
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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hapten Sciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chad S Boomershine, MD, Principal investigator, Clinical Research Solutions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02700373
- Sponsor's protocol ID
- PDC-APB-CL01
- Status last verified
- Feb 2018
- First submitted
- 19 Feb 2016
- Last updated
- 23 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single-Center, Double-Blind, Randomized, Single Ascending Dose Study of PDC-APB in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02700373
- Acronym / sponsor ID
- PDC-APB-CL01
- Conditions
- Contact Dermatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hapten Sciences, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2016 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 7 Mar 2016 (estimated)
- 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 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.
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-APBPDC-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. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (20 listed)
- History of significant contact dermatitis secondary to exposure to poison ivy, poison oak, or poison sumac, as defined in Inclusion Criteria #2 (above)
- 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)
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: Active | Drug | PDC-APB |
| Placebo | Drug | Placebo |
Primary outcome
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: 24 Weeks
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.
1 secondary outcome
Exposure to PDC-APB in study subjects.
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2018.
- Individual participant dataSharing planned: Yes
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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.
Chad S Boomershine, MD principal investigator
Clinical Research Solutions
1 site in 1 country: see every site and its status.
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. at 1 site in United States.
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 7 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: finished, as of the sponsor's last update on 23 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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: 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 23 Feb 2018.