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Pharmacokinetics, Efficacy, and Safety of Encaleret in Pediatric Participants With Autosomal Dominant Hypocalcemia Type 1 (ADH1)
Sponsor: Calcilytix Therapeutics, Inc., a BridgeBio company
Summary
The overall objective of this study is to evaluate the pharmacokinetics (PK), efficacy, and safety of encaleret in pediatric participants from birth to 17 years of age with ADH1.
Official title: A Phase 2/3, Multicenter, Single-Arm, Open-Label Study Evaluating the Pharmacokinetics, Efficacy, and Safety of Encaleret in Pediatric Participants With Autosomal Dominant Hypocalcemia Type 1 (ADH1)
Key Details
Gender
All
Age Range
0 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
28
Start Date
2026-01-30
Completion Date
2030-12
Last Updated
2026-03-11
Healthy Volunteers
No
Interventions
Encaleret
Oral tablets, age-appropriate pediatric formulation (currently under development).
Locations (5)
Yale University
New Haven, Connecticut, United States
Nemours Children's Health
Jacksonville, Florida, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Royal London Hospital
London, United Kingdom
Royal Manchester Children's Hospital
Manchester, United Kingdom