Study to Evaluate the Safety and Tolerability of AD-NP1 in Healthy Human Adult Volunteers

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2026
This is a Phase 1 single‐blind, placebo‐controlled, dose‐escalation study designed toevaluate the safety of AD‐NP1, a humanized monoclonal antibody targeting humanectonucleotide pyrophosphatase/phosphodiesterase‐1 (ENPP1). The study aims to assess themaximum tolerated dose (MTD), pharmacokinetics (PK), pharmacodynamics (PD), andimmunogenicity of AD‐NP1 in healthy volunteers. Participants will be randomized toreceive either AD‐NP1 or placebo, with safety and efficacy monitored in accordance withGood Clinical Practice (GCP) guidelines. The study also seeks to explore changes inhealth‐related quality of life (HRQOL) during the trial.
Epistemonikos ID: 5ae5d5119179607c2358f84638e7ac39e39f857e
First added on: Aug 14, 2026