Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:15 PM
Ignite Modification Date:
2025-12-24 @ 12:15 PM
NCT ID:
NCT05628961
Eligibility Criteria:
Inclusion Criteria:
* Ability of participant to understand the requirements of the study, provide written informed consent, and agree to abide by the study requirements
* Agree to use contraception from time of screening until 14 days after dosing (Day 14) if female is of childbearing potential or male is with female partner of childbearing potential.
* In good general health based on medical history, physical examination (PE), and screening evaluations.
* Negative urine screen for drugs of abuse (except if participant provides prescription justifying use prior to urine screen).
* Body weight ≥ 50 kilogram (kg) and ≤ 110 kg. If body weight is over 110 kg, then body mass index (BMI) will be considered and must be ≤ 40 kg/m\^2.
Exclusion Criteria:
* Inability or unwillingness of a participant to give written informed consent or comply with study protocol.
* Any hematology, chemistry, coagulation, or urinalysis value on screening labs defined in the United States Food and Drug Administration (FDA) Guidance for Industry Toxicity Grading Scale as Grade 1 or higher.
* Any clinically significant electrocardiogram (ECG) abnormality
* Pregnant or breastfeeding
* Active substance abuse or history of any medical or psychiatric condition that would jeopardize the participant's safety or the participant's ability to comply with the protocol.
* Received an organ transplant (solid or bone marrow).
* Received a blood transfusion within 3 months of dosing.
* Difficulty swallowing tablets or capsules.
* Febrile illness or significant infection within 7 days of dosing.
* Symptoms of hypotension (lightheadedness, syncope, balance disturbances, or extreme fatigue) within 48 hours of dosing.
* Hepatitis B virus surface antigen (HBsAg) positive or serologic (antibody positive) evidence of infection with hepatitis C virus (HCV) or human immunodeficiency virus (HIV).
* Tested positive for SARS-CoV-2 (COVID-19) within 21 days of dosing.
* Chelation therapy (e.g., ethylenediaminetetraacetic acid \[EDTA\], diethylenetriamine pentaacetate \[DTPA\]) in the past year.
* Use of laxatives, antibiotics, and/or antacids within 7 days of dosing.
* Use of investigational drugs within 60 days of dosing or 5 half-lives, whichever is longer.
* Received a vaccination within 30 days of dosing.
* Potential allergic reaction to product (oleic acid or HOPO 14-1 product).
* Past or current medical problems or findings from physical examination (PE) or laboratory testing
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05628961
Study Brief:
Protocol Section:
NCT05628961