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

NCT07762001 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-08-14

No results posted yet for this study

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.

Conditions

  • Maximum Tolerated Dose
  • Dose Escalation

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)

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Arjun Deb, MD

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-02
Primary Completion
2028-01-01
Completion
2028-05-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07762001 on ClinicalTrials.gov