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Pharmacokinetics, Efficacy, and Safety of Encaleret in Pediatric Participants With Autosomal Dominant Hypocalcemia Type 1 (ADH1)

Study acronym: CALIBRATE-PEDS
StatusRecruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 5 to 6v7
  2. Study sites: 4 to 5v6
  3. Study sites: 3 to 4v5
  4. Study sites: 2 to 3v4
  5. Study sites: 1 to 2
    • Start date changed from estimate of Feb 10, 2026 to Jan 30, 2026
    v3
  6. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Aug 2025 to Feb 10, 2026
    • Study sites: 0 to 1
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07080385
Lead Sponsor Calcilytix Therapeutics, Inc., a BridgeBio company
Conditions
(from sponsor)		 Autosomal Dominant Hypocalcemia Type 1 (ADH1)
Enrollment 28 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov