Phase 1 Single-blind Placebo-controlled Dose Escalation Safety Study of AD-NP1 (NCT07762001) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Phase 1 Single-blind Placebo-controlled Dose Escalation Safety Study of AD-NP1
United States36 participantsStarted 2026-06-02
Plain-language 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.
Who can participate
Age range
21 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety and tolerability of escalating doses of a single IV dose of AD-NP1
Timeframe: Day of infusion (Day 0) to 28 days post-dose