Maximum Tolerated DosePhase 1NCT07762001
Study to Evaluate the Safety and Tolerability of AD-NP1 in Healthy Human Adult Volunteers
A Phase 1 study testing AD-NP1 in people with Maximum Tolerated Dose and Dose Escalation, run by Arjun Deb, MD at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Maximum Tolerated Dose, Dose Escalation
- What is being tested?
- AD-NP1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2026to 1 May 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Clinical and Translational Research Center
Los Angeles, California, 90095
About this study
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
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
- Being tested
- AD-NP1, Placebo
- Keywords
- Healthy volunteers, Dose toxicity, Monoclonal antibody
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AD-NP1Drug
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).
PlaceboDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 - AD-NP1 (30mg/kg) | Experimental | Subjects receive a single intravenous dose of AD-NP1 at 30 mg/kg Receives: Drug: AD-NP1 |
| Cohort 1 - Placebo | Placebo comparator | Subjects receive a single intravenous dose of placebo matched in volume to the 30 mg/kg dose of AD-NP1 Receives: Drug: Placebo |
| Cohort 2 - AD-NP1 (40 mg/kg) | Experimental | Subjects receive a single intravenous dose of AD-NP1 at 40 mg/kg Receives: Drug: AD-NP1 |
| Cohort 2 - Placebo | Placebo comparator | Subjects receive a single intravenous dose of placebo matched in volume to the 40 mg/kg dose of AD-NP1 Receives: Drug: Placebo |
| Cohort 3 - AD-NP1 (60 mg/kg) | Experimental | Subjects receive a single intravenous dose of AD-NP1 at 60 mg/kg Receives: Drug: AD-NP1 |
| Cohort 3 - Placebo | Placebo comparator | Subjects receive a single intravenous dose of placebo matched in volume to the 60 mg/kg dose of AD-NP1 Receives: Drug: Placebo |
| Cohort 4 - AD-NP1 (100 mg/kg) | Experimental | Subjects receive a single intravenous dose of AD-NP1 at 100 mg/kg Receives: Drug: AD-NP1 |
| Cohort 4 - Placebo | Placebo comparator | Subjects receive a single intravenous dose of placebo matched in volume to the 100 mg/kg dose of AD-NP1 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day of infusion (Day 0) to 28 days post-dose
Secondary outcomes (13)
Maximum Tolerated Dose of AD-NP1
To be determined based on dose limiting toxicities (DLTs) and adverse events
Measured: Day of infusion (Day 0) to 28 days post-dose
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)
Measured: Baseline (pre-dose) up to Day 60 post-dose
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)
Measured: Baseline (pre-dose) up to Day 60 post-dose
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)
Measured: Baseline (pre-dose) up to Day 60 post-dose
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)
Measured: Baseline (Pre-dose), 30 minutes, 1, 2, 4, 6 hours, and Days 1, 3, 7, 14, 28, 60 post-dose.
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)
Measured: Baseline (pre-dose) up to Day 60 post-dose
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)
Measured: Baseline (pre-dose) up to Day 60 post-dose
Plasma Uridine Concentration
Plasma concentrations of uridine will be quantified using Liquid Chromatography-Mass Spectrometry (LC/MS).
Measured: Baseline (pre-dose), and Days 1, 3, 7, 14, and 28 post-dose.
Plasma Cytidine Concentration
Plasma concentrations of cytidine will be quantified using Liquid Chromatography-Mass Spectrometry (LC/MS)
Measured: Baseline (pre-dose), and Days 1, 3, 7, 14, and 28 post-dose.
Plasma Orotidine Concentration
Plasma concentrations of orotidine will be quantified using Liquid Chromatography-Mass Spectrometry (LC/MS)
Measured: Baseline (pre-dose), and Days 1, 3, 7, 14, and 28 post-dose.
Plasma Adenine Concentration
Plasma concentrations of adenine will be quantified using Liquid Chromatography-Mass Spectrometry (LC/MS)
Measured: Baseline (pre-dose), and Days 1, 3, 7, 14, and 28 post-dose.
Plasma Carbamoyl Aspartate Concentration
Plasma concentrations of carbamoyl aspartate will be quantified using Liquid Chromatography-Mass Spectrometry (LC/MS).
Measured: Baseline (pre-dose), and Days 1, 3, 7, 14, and 28 post-dose.
Immunogenicity of a single IV dose of AD-NP1
Determined by measuring levels of circulating anti-drug antibody in blood samples
Measured: Baseline (pre-dose) and Days 1, 7, 14, 28, 90, and 180 post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start2 Jun 2026
- Primary completion1 Jan 2028 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maximum Tolerated DoseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arjun Deb, MD
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor-investigator, Arjun Deb, MD, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07762001
- Sponsor's protocol ID
- 25-1584
- Other IDs
- PR250528
- Status last verified
- Aug 2026
- First submitted
- 6 Aug 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07762001
- Acronym / sponsor ID
- 25-1584
- Conditions
- Maximum Tolerated Dose, Dose Escalation
- Keywords
- Healthy volunteers, Dose toxicity, Monoclonal antibody
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Arjun Deb, MDUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 2 Jun 2026 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 13 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 - AD-NP1 (30mg/kg) | Experimental | Drug: AD-NP1Subjects receive a single intravenous dose of AD-NP1 at 30 mg/kg |
| Cohort 1 - Placebo | Placebo comparator | Drug: PlaceboSubjects receive a single intravenous dose of placebo matched in volume to the 30 mg/kg dose of AD-NP1 |
| Cohort 2 - AD-NP1 (40 mg/kg) | Experimental | Drug: AD-NP1Subjects receive a single intravenous dose of AD-NP1 at 40 mg/kg |
| Cohort 2 - Placebo | Placebo comparator | Drug: PlaceboSubjects receive a single intravenous dose of placebo matched in volume to the 40 mg/kg dose of AD-NP1 |
| Cohort 3 - AD-NP1 (60 mg/kg) | Experimental | Drug: AD-NP1Subjects receive a single intravenous dose of AD-NP1 at 60 mg/kg |
| Cohort 3 - Placebo | Placebo comparator | Drug: PlaceboSubjects receive a single intravenous dose of placebo matched in volume to the 60 mg/kg dose of AD-NP1 |
| Cohort 4 - AD-NP1 (100 mg/kg) | Experimental | Drug: AD-NP1Subjects receive a single intravenous dose of AD-NP1 at 100 mg/kg |
| Cohort 4 - Placebo | Placebo comparator | Drug: PlaceboSubjects receive a single intravenous dose of placebo matched in volume to the 100 mg/kg dose of AD-NP1 |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AD-NP1AD-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 | Cohort 1 - AD-NP1 (30mg/kg), Cohort 2 - AD-NP1 (40 mg/kg), Cohort 3 - AD-NP1 (60 mg/kg), Cohort 4 - AD-NP1 (100 mg/kg) |
| PlaceboPlacebo 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) | Drug | Cohort 1 - Placebo, Cohort 2 - Placebo, Cohort 3 - Placebo, Cohort 4 - Placebo |
Primary outcome
Safety and tolerability of escalating doses of a single IV dose of AD-NP1
Time frame: Day of infusion (Day 0) to 28 days post-dose
Assessed by the incidence of treatment-related Adverse Events (AEs) using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
13 secondary outcomes
Maximum Tolerated Dose of AD-NP1
Time frame: Day of infusion (Day 0) to 28 days post-dose
Maximum Plasma Concentration (Cmax) as a pharmacokinetics (PK) parameter
Time frame: Baseline (pre-dose) up to Day 60 post-dose
Time to Maximum Plasma Concentration (Tmax) as a pharmacokinetics (PK) parameter
Time frame: Baseline (pre-dose) up to Day 60 post-dose
Apparent Volume of Distribution (Vd) as a pharmacokinetics (PK) parameter
Time frame: Baseline (pre-dose) up to Day 60 post-dose
Area Under the Plasma Concentration-Time Curve (AUC) as a pharmacokinetics (PK) parameter
Time frame: Baseline (Pre-dose), 30 minutes, 1, 2, 4, 6 hours, and Days 1, 3, 7, 14, 28, 60 post-dose.
Terminal Elimination Half-life (T(1/2)) as a pharmacokinetics (PK) parameter
Time frame: Baseline (pre-dose) up to Day 60 post-dose
Total Body Clearance (CL) as a pharmacokinetics (PK) parameter
Time frame: Baseline (pre-dose) up to Day 60 post-dose
Plasma Uridine Concentration
Time frame: Baseline (pre-dose), and Days 1, 3, 7, 14, and 28 post-dose.
Plasma Cytidine Concentration
Time frame: Baseline (pre-dose), and Days 1, 3, 7, 14, and 28 post-dose.
Plasma Orotidine Concentration
Time frame: Baseline (pre-dose), and Days 1, 3, 7, 14, and 28 post-dose.
Plasma Adenine Concentration
Time frame: Baseline (pre-dose), and Days 1, 3, 7, 14, and 28 post-dose.
Plasma Carbamoyl Aspartate Concentration
Time frame: Baseline (pre-dose), and Days 1, 3, 7, 14, and 28 post-dose.
Immunogenicity of a single IV dose of AD-NP1
Time frame: Baseline (pre-dose) and Days 1, 7, 14, 28, 90, and 180 post-dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AD-NP1 in people with Maximum Tolerated Dose and Dose Escalation, run by Arjun Deb, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of escalating doses of a single IV dose of AD-NP1 (time frame: Day of infusion (Day 0) to 28 days post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.