Eligibility Details:
Inclusion Criteria:
Cohort A:
- Subject is in good general health, according to the investigator's judgment based on
vital signs, medical history, physical examination, and laboratory tests performed.
For woman of childbearing potential, has had a negative urine pregnancy test at
screening and on Day 1 (baseline).
- Subjects has acceptable reaction to selected antigens.
- Subject is willing to participate and is capable of giving informed consent. Note:
Consent must be obtained prior to any study-related procedures.
- Subjects must be willing to comply with all study procedures and must be available for
the duration of the study.
Cohort B:
- Subject is in good general health, according to the investigator's judgment based on
vital signs, medical history, physical examination, and laboratory tests performed.
- For subject (woman) involved in any sexual intercourse that could lead to pregnancy,
subject agrees that an effective contraceptive method will be used, from at least 4
weeks prior to screening until at least 4 weeks after the last study product
administration. Effective contraceptive methods include hormonal contraceptives
(combined oral contraceptive, patch, vaginal ring, injectable, or implant),
intrauterine devices or intrauterine systems, vasectomized partner(s), tubal ligation,
or a barrier method of contraception (male condom, female condom, cervical cap,
diaphragm, contraceptive sponge) in conjunction with spermicide.
Note: Hormonal contraceptives must have been on a stable dose for at least 4 weeks before
screening.
Note: The above list of contraceptive methods does not apply to subjects who are abstinent
for at least 4 weeks before Day 1 and will continue to be abstinent from penile-vaginal
intercourse throughout the study. The reliability of sexual abstinence needs to be
evaluated in relation to the duration of the clinical trial and the preferred and usual
lifestyle of the participant.
Note: Women of nonchildbearing potential are defined as follows:
- Female who has had surgical sterilization (hysterectomy, bilateral oophorectomy, or
bilateral salpingectomy) or;
- Female who has had a cessation of menses for at least 12 months prior to screening
without an alternative medical cause, and a follicle-stimulating hormone (FSH) test
confirming nonchildbearing potential (refer to laboratory reference ranges for
confirmatory levels).
- For woman of childbearing potential, has had a negative urine and serum pregnancy
test at screening and negative urine pregnancy test at Day 1 (baseline).
- Subject is willing to participate and is capable of giving informed consent.
Note: Consent must be obtained prior to any study-related procedures.
- Subjects must be willing to comply with all study procedures and must be
available for the duration of the study.
Exclusion Criteria:
Cohort A:
- Subject is a female who is breastfeeding, pregnant, or who is planning to become
pregnant during the study.
- Subject has a known history of severe allergic reaction (local or systemic) to the
tested hapten.
- Subject has a history of skin disease or presence of skin condition that, in the
opinion of the investigator, would interfere with the study assessments including
active urticaria, psoriasis, atopic dermatitis, active contact dermatitis and excited
(angry back) skin syndrome.
- Medical history of dermatographism.
- History of contact dermatitis to medical adhesive bandages or glue.
- Presence of any scar tissue, tattoos, scratches, open sores, excessive hair, or skin
damages at tested/injection sites that in the opinion of the investigator may
interfere with study evaluations.
- Subject is known to have immune deficiency or is immunocompromised.
- Subject has a known history of chronic infectious disease (e.g., hepatitis B,
hepatitis C, or infection with human immunodeficiency virus).
- Subject has evidence or suspicion of active or latent TB or a clear history of
treatment for TB disease or infection
- Subject has a hypersensitivity to any of the components of the patch test matrix or
the hapten excipients.
- Subject has a known hypersensitivity to Tuberculin Purified Protein Derivative or to
any components of the formulation or container. .
- Subject previously had a severe reaction (e.g., necrosis, blistering, anaphylactic
shock or ulcerations) to a previous tuberculin skin test
Cohort B:
- Subject is a female who is breastfeeding, pregnant, or who is planning to become
pregnant during the study.
- Subject has a known history of severe allergic reaction (local or systemic) to the
tested hapten.
- Subject has a history of skin disease or presence of skin condition that, in the
opinion of the investigator, would interfere with the study assessments including
active urticaria, psoriasis, atopic dermatitis, active contact dermatitis and excited
(angry back) skin syndrome.
- Medical history of dermatographism.
- History of contact dermatitis to medical adhesive bandages or glue.
- Presence of any scar tissue, tattoos, scratches, open sores, excessive hair, or skin
damages at tested/injection sites that in the opinion of the investigator may
interfere with study evaluations.
- Subject is known to have immune deficiency or is immunocompromised.
- Subject has a known history of chronic infectious disease (e.g., hepatitis B,
hepatitis C, or infection with human immunodeficiency virus).
- Subject has a contra-indication, or who would be at increased risk of adverse effects
to systemic corticosteroid (e.g. active systemic fungal infection, extensive viral
disease (such as measles, chickenpox and herpes simplex on the eye), diabetes, heart
problems, peptic ulcer, inflammatory bowel disease, diverticulitis, active depression
or psychosis, osteoporosis, cataracts, glaucoma, bleeding or clotting problems, high
blood pressure, neurological problems, hypothyroidism, myasthenia, kidney diseases,
liver diseases, history of low potassium or calcium in blood) that in the opinion of
the investigator may put the subject at risk during the trial.
- Subject had a treated or non-treated systemic infection (bacterial or viral) within 4
weeks prior to screening until Day 1 (baseline).
- Subject has evidence or suspicion of active or latent TB or a clear history of
treatment for TB disease or infection
- Subject received a live or live/attenuated vaccination within 4 weeks prior screening
or intends to receive a live or live/attenuated vaccination during the course of the
study.
- Subject has a positive result to the QuantiFERON-TB Gold test or Tuberculin Purified
Protein Derivative (Mantoux) test (if applicable) at the screening visit.
- Subject has any clinically significant medical condition or physical/laboratory/ vital
signs abnormality that would, in the opinion of the investigator, put the subject at
undue risk or interfere with interpretation of study results.
- Use of any other concurrent medications known or suspected to interfere with study
evaluations or that may pose a safety risk.
- Subject has a hypersensitivity to any of the components of the patch test matrix or
the hapten excipients.
- Subject has a known hypersensitivity to Tuberculin Purified Protein Derivative or to
any components of the formulation or container.
- Subject previously had a severe reaction (e.g., necrosis, blistering, anaphylactic
shock or ulcerations) to a previous tuberculin skin test
- Subject has a known or suspected allergy or intolerance to excipients of the placebo.
- Subject has a known or suspected allergy to prednisone or any of its excipients or any
other corticosteroids.
common.study.methods.has-drugs-yes
common.study.methods.is-healthy-no
