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Active, not recruitingNCT07762001Updated Aug 14, 2026

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

A Phase 1 interventional study of AD-NP1 and Placebo in Maximum Tolerated Dose and Dose Escalation, sponsored by Arjun Deb, MD. Active, not recruiting at 1 site in United States. Open to participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-14.

Sponsored by Arjun Deb, MD · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
21 Years to 65 Years
Sex
All
01

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.

02

Conditions studied

  • Maximum Tolerated Dose
  • Dose Escalation

Keywords

  • Healthy volunteers
  • Dose toxicity
  • Monoclonal antibody
03

Who can participate

Ages eligible
21 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Body weight ≤ 90kg
  • Ability to understand and the willingness to sign a written informed consent document
  • Study subject must have read, understood, and provided written informed consent and HIPAA authorization after the nature of the study has been fully explained
  • Be in general good health without history of any of the conditions listed in exclusion criteria
  • No use of any tobacco products for at least 6 months
  • Woman/women of childbearing potential (WOCBP) must agree not to become pregnant from the time of study enrollment until at least 6 months after the completion of the monoclonal antibody infusion. If a WOCBP is sexually active and has no history of hysterectomy or tubal ligation, she must agree to use hormonal or barrier birth control with spermicidal gel
  • Sexually active male subjects must use a barrier method of contraception during the study

  • Screening laboratory values must meet the following criteria:

    • WBC (>3,000 - \<11,000/mm\^3)
    • Platelets (>100,000/mm\^3)
    • Hemoglobin (>10.5 gm/dl)
    • Creatinine (\<1.1 x upper limit of normal [ULN])
    • BUN (\<1.25 x ULN)
    • AST (\<1.1 x ULN)
    • ALT (\<1.1 x ULN)
    • Alkaline Phosphatase (\<1.1 x ULN)
    • Bilirubin (\<1.1 x ULN)
    • Glucose-non-fasting (> 60 mg/dl and \< 115 mg/dl)
  • Human immunodeficiency virus (HIV)-infected individuals on effective antiretroviral therapy with undetectable viral load within 6 months are eligible for this trial
  • For subjects with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
  • Individuals with a history of hepatitis C virus (HCV) infection must have been treated and cured. For individuals with HCV infection who are currently on treatment are eligible if they have an undetectable HCV viral load

Exclusion criteria

Exclusion Criteria:

  • Previous exposure to humanized or human monoclonal antibodies whether FDA approved or investigational
  • Weight > 90 kg
  • History of any of the following illnesses or conditions:
  • a. Respiratory condition (such as asthma requiring daily medication)
  • b. Clinically immunocompromised due to any primary immune or autoimmune deficiency, as a result of chronic disease, cancer or medication used to treat these diseases
  • c. Blood dyscrasias
  • d. Psychiatric disorder that precludes compliance with the clinical protocol
  • e. Hepatitis
  • Any chronic condition requiring daily prescription or over-the-counter medicine except for vitamins and birth control products
  • History of drug or alcohol abuse within previous 12 months or a positive urine toxicology screen within 24 hours of initial screening
  • History of a previous severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis
  • Physical finding on examination considered clinically significant such as heart murmur (other than functional), hepatosplenomegaly, lymphadenopathy, or focal neurological deficit
  • Urinalysis positive for > trace protein, >5 RBC/HPF or >5 WBC/HPF
  • Positive serology for HIV antibody, HCV antibody or Hepatitis B surface antigen
  • Positive serum pregnancy test during screening or positive urine pregnancy test within 24 hours of monoclonal antibody administration, or an unwillingness to undergo pregnancy testing
  • Currently breast-feeding
  • Receipt of an FDA approved vaccine or any investigational study agent within previous 30 days
  • Any other condition that in the opinion of the investigator would jeopardize the safety or rights of the subject participating in the study
04

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Single (Participant)
Enrollment
36 participants (estimated)

Study arms

  • Experimental
    Cohort 1 - AD-NP1 (30mg/kg)

    Subjects receive a single intravenous dose of AD-NP1 at 30 mg/kg

    Drug: AD-NP1

  • Placebo comparator
    Cohort 1 - Placebo

    Subjects receive a single intravenous dose of placebo matched in volume to the 30 mg/kg dose of AD-NP1

    Drug: Placebo

  • Experimental
    Cohort 2 - AD-NP1 (40 mg/kg)

    Subjects receive a single intravenous dose of AD-NP1 at 40 mg/kg

    Drug: AD-NP1

  • Placebo comparator
    Cohort 2 - Placebo

    Subjects receive a single intravenous dose of placebo matched in volume to the 40 mg/kg dose of AD-NP1

    Drug: Placebo

  • Experimental
    Cohort 3 - AD-NP1 (60 mg/kg)

    Subjects receive a single intravenous dose of AD-NP1 at 60 mg/kg

    Drug: AD-NP1

  • Placebo comparator
    Cohort 3 - Placebo

    Subjects receive a single intravenous dose of placebo matched in volume to the 60 mg/kg dose of AD-NP1

    Drug: Placebo

  • Experimental
    Cohort 4 - AD-NP1 (100 mg/kg)

    Subjects receive a single intravenous dose of AD-NP1 at 100 mg/kg

    Drug: AD-NP1

  • Placebo comparator
    Cohort 4 - Placebo

    Subjects receive a single intravenous dose of placebo matched in volume to the 100 mg/kg dose of AD-NP1

    Drug: Placebo

Interventions

  • DrugAD-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).

  • DrugPlacebo

    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)

05

What researchers measure

Primary outcomes

  1. Safety and tolerability of escalating doses of a single IV dose of AD-NP1

    Assessed by the incidence of treatment-related Adverse Events (AEs) using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

    Time frame: Day of infusion (Day 0) to 28 days post-dose

Secondary outcomes

  1. Maximum Tolerated Dose of AD-NP1

    To be determined based on dose limiting toxicities (DLTs) and adverse events

    Time frame: Day of infusion (Day 0) to 28 days post-dose

  2. Maximum Plasma Concentration (Cmax) as a pharmacokinetics (PK) parameter

    Peak plasma concentration obtained directly from the experimental data points, to be measured in Nanograms per milliliter (ng/mL)

    Time frame: Baseline (pre-dose) up to Day 60 post-dose

  3. Time to Maximum Plasma Concentration (Tmax) as a pharmacokinetics (PK) parameter

    Tmax presents the time at which Cmax is observed, to be measured in hours (h) and minutes (m)

    Time frame: Baseline (pre-dose) up to Day 60 post-dose

  4. Apparent Volume of Distribution (Vd) as a pharmacokinetics (PK) parameter

    Volume of distribution calculated during the terminal elimination phase following administration, to be measured in Liters (L) or Liters per kilogram (L/kg)

    Time frame: Baseline (pre-dose) up to Day 60 post-dose

  5. Area Under the Plasma Concentration-Time Curve (AUC) as a pharmacokinetics (PK) parameter

    AUC calculated using the linear-log trapezoidal rule from time zero (pre-dose) to the last quantifiable concentration point to be measured in Nanogram x hours per milliliter (ng \* h/mL)

    Time frame: Baseline (Pre-dose), 30 minutes, 1, 2, 4, 6 hours, and Days 1, 3, 7, 14, 28, 60 post-dose.

  6. Terminal Elimination Half-life (T(1/2)) as a pharmacokinetics (PK) parameter

    The rate at which Ad-NP1 is cleared from the systemic plasma circulation, to be measured in Liters per hour (L/h) or Milliliters per minute per kilogram (mL/min/kg)

    Time frame: Baseline (pre-dose) up to Day 60 post-dose

  7. Total Body Clearance (CL) as a pharmacokinetics (PK) parameter

    The rate at which AD-NP1 is cleared from the systemic plasma circulation, to be measured in Liters per hour (L/h) or Milliliters per minute per kilogram (mL/min/kg)

    Time frame: Baseline (pre-dose) up to Day 60 post-dose

  8. Plasma Uridine Concentration

    Plasma concentrations of uridine will be quantified using Liquid Chromatography-Mass Spectrometry (LC/MS).

    Time frame: Baseline (pre-dose), and Days 1, 3, 7, 14, and 28 post-dose.

  9. Plasma Cytidine Concentration

    Plasma concentrations of cytidine will be quantified using Liquid Chromatography-Mass Spectrometry (LC/MS)

    Time frame: Baseline (pre-dose), and Days 1, 3, 7, 14, and 28 post-dose.

  10. Plasma Orotidine Concentration

    Plasma concentrations of orotidine will be quantified using Liquid Chromatography-Mass Spectrometry (LC/MS)

    Time frame: Baseline (pre-dose), and Days 1, 3, 7, 14, and 28 post-dose.

  11. Plasma Adenine Concentration

    Plasma concentrations of adenine will be quantified using Liquid Chromatography-Mass Spectrometry (LC/MS)

    Time frame: Baseline (pre-dose), and Days 1, 3, 7, 14, and 28 post-dose.

  12. Plasma Carbamoyl Aspartate Concentration

    Plasma concentrations of carbamoyl aspartate will be quantified using Liquid Chromatography-Mass Spectrometry (LC/MS).

    Time frame: Baseline (pre-dose), and Days 1, 3, 7, 14, and 28 post-dose.

  13. Immunogenicity of a single IV dose of AD-NP1

    Determined by measuring levels of circulating anti-drug antibody in blood samples

    Time frame: Baseline (pre-dose) and Days 1, 7, 14, 28, 90, and 180 post-dose

06

Study locations

1 site
  • UCLA Clinical and Translational Research Center
    Los Angeles, California 90095, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07762001
Lead sponsor
Arjun Deb, MD
Collaborators
United States Department of Defense
Responsible party
Arjun Deb, MD (Professor of Medicine (Cardiology) and Molecular, Cell & Developmental Biology, University of California, Los Angeles) — Sponsor-investigator
First posted
Aug 13, 2026
Start date
Jun 2, 2026
Primary completion
Jan 1, 2028 (estimated)
Completion
May 1, 2028 (estimated)
Last update
Aug 14, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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