Study of Single Oral Doses of HOPO 14-1 Evaluating Safety, Tolerability, Pharmacokinetics

Stanford Research Institute (SRI) International

Status and phase

Completed

Phase 1

Conditions

Toxicity;Chemical

Treatments

Drug: HOPO 14-1

Study type

Interventional

Funder types

Industry

Identifiers

NCT05628961

SRI-HOPO-01

Details and patient eligibility

About

The study objectives are to define the safety and tolerability profile of oral, single ascending dose (SAD) levels of HOPO 14-1 capsules in cohorts of healthy participants and to assess the pharmacokinetic (PK) and excretion profile of HOPO 14-1. The study hypothesis is that a single dose of HOPO 14-1 will be safe and tolerable up to 7500 mg.

Full description

The currently available therapy for radionuclide internal contamination is suboptimal. Pharmacological and toxicological data support the clinical development of HOPO 14-1 for decorporation of radionuclides.

Enrollment

42 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

42 participants in 7 patient groups

Cohort 1: 100 mg

Experimental group

Description: