Ignite Creation Date:
2024-05-06 @ 6:19 PM
Last Modification Date:
2024-10-26 @ 2:46 PM
Study NCT ID:
NCT05628961
Status:
RECRUITING
Last Update Posted:
2023-05-24
First Post:
2022-11-17
Brief Title:
Study of Single Oral Doses of HOPO 14-1 Evaluating Safety Tolerability Pharmacokinetics
Sponsor:
SRI International
Organization:
SRI International
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:
RECRUITING
Status Verified Date:
2023-05
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:
None
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?:
None