A phase 1, randomized, double-blind, placebo-controlled, single-dose escalation, multiple-dose escalation, and food effect study of RPT193 in healthy subjects and patients with moderate to severe atopic dermatitis
- Conditions
- atopische dermatitisasthmaAtopic dermititis
- Registration Number
- NL-OMON49945
- Lead Sponsor
- RAPT Therapeutics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 76
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Part A<br /><br>- To evaluate the safety and tolerability of single oral ascending doses of<br /><br>RPT193 administered to healthy male and female subjects.<br /><br>Part B<br /><br>- To evaluate safety and tolerability of multiple oral ascending doses of<br /><br>RPT193 administered for 7 days to healthy male and female subjects.<br /><br>Part C<br /><br>- To evaluate the safety and tolerability of RPT193 administered orally for 28<br /><br>days to patients with moderate to severe AD.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Part A<br /><br>* To evaluate the PK of RPT193 following administration of single oral<br /><br>ascending doses of<br /><br>RPT193 administered to healthy male and female subjects.<br /><br>* To assess the FE on the PK of RPT193 following administration of a single<br /><br>oral dose of<br /><br>RPT193 administered to healthy male and female subjects.<br /><br>* Part B<br /><br>* To evaluate the PK of RPT193 following administration of multiple oral<br /><br>ascending doses of<br /><br>RPT193 administered for 7 days to healthy male and female subjects.<br /><br>* Part C<br /><br>* To evaluate the PK of RPT193 following administration of multiple oral doses<br /><br>of RPT193<br /><br>administered orally for 28 days to patients with moderate to severe AD.</p><br>