atopische dermatitis asthma Atopic dermititis
Conditions
Interventions
Part A:
RPT193 or placebo will be taken once (in each period for Group A3) as oral
capsules with 240 mL of (tap) water, without chewing on the capsules. The hands
and mouth will be checked after th
Sponsors
RAPT Therapeutics, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Part A and B: - Sex: male or female - Age: 18-55 years, inclusive, at the time of consent. - Body mass index (BMI): 18.0*30.0 kg/m2 at screening. - Weight: *50 kg. - Status: healthy subjects (Note: For Groups A5 and A6, the age range will be 18-54 years, inclusive, at the time of consent to mitigate Coronavirus Disease 2019 [COVID-19] risks). Part C: - Male or female patient aged 18 to 65 years, inclusive, at the time of consent. - Patient has a body mass index *18 and *35 kg/m2 at screening. - Patient has at least a 12-month history of AD and had no significant flares in AD for at least 4 weeks before screening, as determined by the Investigator through patient interview at the screening visit or information obtained from medical chart or patient*s physician. - Patient has clinically confirmed diagnosis of active AD, according to the revised Hanifin and Rajka criteria
Exclusion criteria
Exclusion criteria: Part A and B: Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. Participation in a drug study within 60 days prior to (the first) drug administration in the current study. Participation in more than 4 other drug studies in the 12 months prior to (the first) drug administration in the current study. Donation or loss of more than 100 mL of blood within 60 days prior to (the first) drug administration. Donation or loss of more than 1.5 liters of blood (for male subjects) / more than 1.0 liters of blood (for female subjects) in the 10 months prior to (the first) drug administration in the current study. Part C: Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. - Patient has a history of skin disease or presence of skin condition that, in the opinion of the Investigator, would interfere with the study assessments. Note: Fungal infection of nail beds is allowed. - Patient who is still participating in a clinical trial or who has participated in a clinical trial within 1 month prior to the Screening visit. - Patient has used tanning beds or phototherapy (narrowband UVB [NBUVB], UV-B, ultraviolet A1 [UVA1], or psoralen-UV-A [PUVA]) within 4 weeks prior to the Baseline visit. - Patient has received treatment with systemic immunosuppressive/ immunomodulating drugs (eg, methotrexate, cyclosporine A, or systemic Janus kinase [JAK] inhibitors), immunoglobulins, blood products and/or systemic corticosteroids (eg, oral, intravenous, intraarticular, rectal) within 4 weeks prior to the Baseline visit. Note: Intranasal corticosteroids and inhaled corticosteroids are allowed. Eye and ear drops containing corticosteroids are also allowed. - Patient has used any topical medicated treatment that could affect AD within 2 weeks prior to the Baseline visit, including, but not limited to, topical corticosteroids, crisaborole, calcineurin inhibitors, tars, antimicrobials, medical devices, and bleach baths.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A - To evaluate the safety and tolerability of single oral ascending doses of RPT193 administered to healthy male and female subjects. Part B - To evaluate safety and tolerability of multiple oral ascending doses of RPT193 administered for 7 days to healthy male and female subjects. Part C - To evaluate the safety and tolerability of RPT193 administered orally for 28 days to patients with moderate to severe AD. | — |
Secondary
| Measure | Time frame |
|---|---|
| Part A * To evaluate the PK of RPT193 following administration of single oral ascending doses of RPT193 administered to healthy male and female subjects. * To assess the FE on the PK of RPT193 following administration of a single oral dose of RPT193 administered to healthy male and female subjects. * Part B * To evaluate the PK of RPT193 following administration of multiple oral ascending doses of RPT193 administered for 7 days to healthy male and female subjects. * Part C * To evaluate the PK of RPT193 following administration of multiple oral doses of RPT193 administered orally for 28 days to patients with moderate to severe AD. | — |
Countries
Netherlands
Outcome results
None listed