NCT05628961

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

An Open-Label, First-In-Human Study of Single Oral Doses of HOPO 14-1 Evaluating Safety, Tolerability, Pharmacokinetics, and Excretion in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: SRI International · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Toxicity;Chemical

Interventions

Type	Name	Description
DRUG	HOPO 14-1	HOPO 14-1 contains the active pharmaceutical ingredient (API) 3, 4, 3-LI(1, 2-HOPO) formulated with a permeability enhancer, sodium oleate, in capsule form.

Timeline

• Start date: 2023-03-15
• Primary completion: 2025-08-04
• Completion: 2025-08-04
• First posted: 2022-11-29
• Last updated: 2025-11-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study