A Study to Investigate Safety and Efficacy of KB111 for the Treatment of Hailey-Hailey Disease
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age12+
SponsorKrystal Biotech, Inc.
About this trial
An open-label study to evaluate the safety and efficacy of KB111 in pediatric and adult subjects with Hailey-Hailey Disease
Eligibility criteria
Qualifiers
The participant must have read, understood, and signed an Institutional Review Board (IRB)- approved Informed Consent Form and must be willing and able to comply with study procedures and instructions
Aged ≥ 12 years of age at the time of informed consent/assent
Documented clinical diagnosis of HHD with confirmed ATP2C1 variant by genetic testing
A negative pregnancy test prior to initial dose for subjects of child-bearing potential
Disqualifiers
Participation in another clinical study or treatment with an investigational agent 30 days or 5 half-lives, whichever is longer, prior to initial dosing in Week 1
Participant who is pregnant or nursing
Participant who is unwilling to comply with contraception requirements per protocol (for subjects of child-bearing potential)
Participant who is known to be non-compliant or is unlikely to comply with the requirements of the study protocol, in the opinion of the Investigator
Trial design
Treatments tested in this trial
- KB111
Treatment groups
7 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov