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

This is a Phase 1 single-blind, placebo-controlled, dose-escalation study designed to evaluate the safety of AD-NP1, a humanized monoclonal antibody targeting human ectonucleotide pyrophosphatase/phosphodiesterase-1 (ENPP1). The study aims to assess the maximum tolerated dose (MTD), pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of AD-NP1 in healthy volunteers. Participants will be randomized to receive either AD-NP1 or placebo, with safety and efficacy monitored in accordance with Good Clinical Practice (GCP) guidelines. The study also seeks to explore changes in health-related quality of life (HRQOL) during the trial.

NCT Number	NCT07762001
Lead Sponsor	Arjun Deb, MD Collaborators: United States Department of Defense
Conditions	Maximum Tolerated Dose, Dose Escalation
Enrollment	36 participants
Start Date	2026-06-02
Primary Completion	2028-01-01 (estimated)
Study Completion	2028-05-01 (estimated)
Updated on ClinicalTrials.gov	2026-08-14