Clinical trial NCT05628961: Study of Single Oral Doses of HOPO 14-1 Evaluating Safety, Tolerability, Pharmacokinetics
Official title: An Open-Label, First-In-Human Study of Single Oral Doses of HOPO 14-1 Evaluating Safety, Tolerability, Pharmacokinetics, and Excretion in Healthy Participants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Toxicity;Chemical
Keywords: Internal Radionuclide Contamination
Lead sponsor: SRI International
Sponsor class: INDUSTRY
First posted: 2022-11-29
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

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 or blood 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

Primary outcomes:
measure: Number of Participants with One or More Adverse Events
timeFrame: Up to 14 days
measure: Number of Participants with One or More Drug-Related Adverse Events
timeFrame: Up to 14 days
measure: Number of Participants with One or More Adverse Events by Maximum Severity
timeFrame: Up to 14 days
measure: Number of Participants with One or More Serious Adverse Events
timeFrame: Up to 14 days
Secondary outcomes:
measure: Observed Maximum Plasma Concentration (Cmax)
timeFrame: Up to Day 7
measure: Observed Time to Reach Cmax (Tmax)
timeFrame: Up to Day 7
measure: Area Under the Plasma Concentration Time Curve up to the Last Blood Collection Time with a Measurable Concentration (AUClast)
timeFrame: Up to Day 7
measure: Extrapolated to Infinity (AUC0-inf)
timeFrame: Up to Day 7
measure: Terminal Half-Life (t 1/2)
timeFrame: Up to Day 7
measure: Apparent Volume of Distribution after Oral Administration (V/F)
timeFrame: Up to Day 7
measure: Oral Systemic Clearance Rate (CL/F)
timeFrame: Up to Day 7
measure: Cumulative Amount Excreted in Urine
timeFrame: Up to Day 7
measure: Cumulative Amount Excreted in Feces
timeFrame: Up to Day 7
Other outcomes:
Locations:
city: Plymouth
country: United States
facility: SRI Biosciences Clinical Trials Unit
state: Michigan
Study officials:
affiliation: SRI International
name: Principal Investigator
role: PRINCIPAL_INVESTIGATOR
References: