Ignite Creation Date:
2025-12-24 @ 12:15 PM
Ignite Modification Date:
2026-01-07 @ 5:12 PM
Study NCT ID:
NCT05628961
Status:
COMPLETED
Last Update Posted:
2025-11-14
First Post:
2022-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Single Oral Doses of HOPO 14-1 Evaluating Safety, Tolerability, Pharmacokinetics
Sponsor:
SRI International
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: