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ACTIVE NOT RECRUITING
NCT07762001
PHASE1

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

Sponsor: Arjun Deb, MD

View on ClinicalTrials.gov

Summary

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.

Official title: A Phase 1 Single-blind, Placebo-controlled, Dose Escalation Study to Evaluate the Safety of AD-NP1, a Humanized Monoclonal Antibody Targeting Human ENPP1

Key Details

Gender

All

Age Range

21 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2026-06-02

Completion Date

2028-05-01

Last Updated

2026-08-14

Healthy Volunteers

Yes

Interventions

DRUG

AD-NP1

AD-NP1 is a humanized monoclonal antibody targeting the catalytic domain of human ENPP1. It is administered intravenously at escalating doses (30 mg/kg, 40 mg/kg, 60 mg/kg, and 100 mg/kg).

DRUG

Placebo

Placebo is a normal saline solution administered intravenously in volumes matched to the corresponding AD-NP1 doses (30 mg/kg, 40 mg/kg, 60 mg/kg, and 100 mg/kg)

Locations (1)

UCLA Clinical and Translational Research Center

Los Angeles, California, United States