Status:
COMPLETED
A Single and Multiple Ascending Dose Trial of KT-474 in Healthy Adult Volunteers and Patients With Atopic Dermatitis (AD) or Hidradenitis Suppurativa (HS)
Lead Sponsor:
Kymera Therapeutics, Inc.
Conditions:
Healthy Volunteer
Atopic Dermatitis
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
KT-474 is an oral heterobifunctional small molecule IRAK4 degrader being developed for the treatment of interleukin-1 receptor (IL-1R)/toll-like receptor (TLR)-driven immune-inflammatory diseases. Thi...
Detailed Description
This is a first-in-human (FIH), Phase 1 randomized, placebo-controlled, single and multiple ascending dose trial of KT-474 that will characterize the safety, PK and PD of orally administered KT-474 af...
Eligibility Criteria
Inclusion
- Healthy Volunteer (Parts A and B)
- Male and female subjects, including female subjects of child bearing potential, between the ages of 18 and 55 with a weight at least 50 kg and a body mass index (BMI) between 18.0 and 30.0 kg/m2.
- Subjects confirmed as negative in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection test at Screening and on Day -2.
- Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
- Agreement and ability to comply with all contraception requirements if applicable.
- All subjects must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Healthy Volunteer (Parts A and B)
Exclusion
- Evidence or history of a clinically significant medical condition or other condition that might significantly interfere with the absorption, distribution, metabolism, or excretion of study drug, or place the subject at an unacceptable risk as a participant in this study.
- Healthy volunteers who have a clinically relevant history or presence of respiratory, GI, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, or connective tissue diseases or disorders.
- Healthy volunteers who have any known factor, condition, or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as drug or alcohol dependence or psychiatric disease.
- Female Healthy volunteers who are pregnant, trying to become pregnant or lactating or breastfeeding.
- Healthy volunteers who have participated in any investigational drug or device clinical study within 3 months prior to first dosing on this study.
- Healthy volunteers who have previously participated in a study with an investigational product or device involving the dosing of a biological targeted at any immune pathway within 1 year prior to Screening.
- AD or HS Patient (Part C) Inclusion Criteria:
- Male or female patients aged 18 years to 55 years (inclusive) at the time of Screening, and in generally good health, except for AD or HS, and has a BMI of 17.5 to 35.0 kg/m2; and a total body weight \>50 kg (110 lb).
- Diagnosis of AD or HS for at least 6 months.
- Patients with AD: having at least 10% treatable percentage body surface area at Screening or on Admission (excluding the scalp and designated venous access areas).
- Willingness and ability to comply with all contraception requirements as applicable based on reproductive status.
- Has adequate venous access with venous access sites having AD-unaffected, non-infected skin to permit repeated PK sampling.
- Female patients must have a negative result for the serum pregnancy test at the Screening Visit and on admission.
- Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.
- Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Patients with HS: A total Abscess and Inflammatory Nodule count of ≥4 at baseline
- AD or HS Patient (Parts C)
Key Trial Info
Start Date :
February 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 20 2022
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT04772885
Start Date
February 23 2021
End Date
October 20 2022
Last Update
October 24 2022
Active Locations (14)
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1
Medical Dermatology Specialists
Phoenix, Arizona, United States, 85006
2
Southwest Skin Specialists 32nd St
Phoenix, Arizona, United States, 85018
3
Southwest Skin Specialists Tatum
Phoenix, Arizona, United States, 85028
4
Beatrice Keller Clinic
Sun City West, Arizona, United States, 85375