A Single and Multiple Ascending Dose Trial of KT-474 in Healthy Adult Volunteers and Patients With Atopic Dermatitis (AD) or Hidradenitis Suppurativa (HS)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Atopic Dermatitis
- Healthy Volunteer
- Hidradenitis Suppurativa
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: Single ascending dose escalation and multiple ascending dose escalation study followed by an evaluation of food effects on absorptionMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: randomized double blindPrimary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 55 years
- Gender
- Both males and females
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 after a single dose (Part A) and after repeated dosing first in healthy adult volunteers (Part B) and ...
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 after a single dose (Part A) and after repeated dosing first in healthy adult volunteers (Part B) and then in patients with AD or HS (Part C). Initially, a dose range of KT-474 in single ascending dose (SAD) escalation cohorts will be explored in healthy subjects. Up to two single dose cohorts of healthy subjects is also planned to understand food effects (FE) on the PK of KT-474. Enrollment of healthy subjects into 2-week multiple ascending dose (MAD) escalation cohorts will be initiated once sufficient safety and PK data from multiple SAD cohorts are available to inform the safe starting dose for the 2-week MAD portion of the study. After the MAD portion in healthy subjects is completed, the safety, PK, and PD of a dose of KT-474 that was found to be safe in healthy subjects when administered for 2 weeks will then be evaluated in AD or HS subjects for two weeks of dosing.
Tracking Information
- NCT #
- NCT04772885
- Collaborators
- Not Provided
- Investigators
- Study Director: Ashwin Gollerkeri, MD Kymera Therapeutics, Inc.
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