A Single and Multiple Ascending Dose Trial of KT-474 in Healthy Adult Volunteers and Patients With Atopic Dermatitis (AD) or Hidradenitis Suppurativa (HS)
NCT04772885 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 154
Last updated 2022-10-24
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. This first-in-human (FIH) study will characterize the safety, tolerability and the pharmacokinetics/pharmacodynamics (PK/PD) of a single ascending dose and multiple ascending doses of KT-474 in healthy volunteers and patients with atopic dermatitis (AD) or hidradenitis suppurativa (HS). The effects of food on the absorption of KT-474 will also be evaluated in healthy volunteers.
Conditions
- Healthy Volunteer
- Atopic Dermatitis
- Hidradenitis Suppurativa
Interventions
- DRUG
-
KT-474/Placebo
KT-474 or matching placebo oral tablet(s)
- DRUG
-
KT-474
KT-474 oral tablet(s)
Sponsors & Collaborators
-
Kymera Therapeutics, Inc.
lead INDUSTRY
Principal Investigators
-
Ashwin Gollerkeri, MD · Kymera Therapeutics, Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-02-23
- Primary Completion
- 2022-10-20
- Completion
- 2022-10-20
- FDA Drug
- Yes
Countries
- United States
Study Locations
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