Open
Actively Recruiting
Study to Evaluate the Safety and Tolerability of AD-NP1 in Healthy Human Adult Volunteers
About
Brief 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.
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
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:
- 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
Join this Trial
Contact our clinical trial navigators for opportunities that may be suitable for you
Share:
Study Stats
Protocol No.
25-1584
Category
Healthy Volunteers
Principal Investigator
Contact
- Noah Federman
- Koren Kwag
Location
- UCLA Westwood