Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2026-01-01 @ 1:50 AM
Study NCT ID:
NCT06584058
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-09-04
First Post:
2024-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HPP737 Substance Balance Study in Human
Sponsor:
Newsoara Biopharma Co., Ltd.
Organization:
Study Overview
Official Title:
[14C] A Single-center, Nonrandomized, Open, Single-dose Substance Balance Study of HPP737 in Healthy Subjects
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
Main research purpose
1. Quantitative analysis of the total amount of radioactivity in excreta (urine and feces) of male healthy subjects after oral administration of \[14C\]HPP737, to obtain the cumulative excretion rate and main excretion routes of human radioactivity;
2. To identify the main metabolites in the offspring of \[14C\]HPP737 in healthy male subjects, and to determine the main biotransformation pathway and main metabolite structure;
3. To investigate the distribution of total radioactivity in whole blood and plasma and the pharmacokinetics of total plasma radioactivity in healthy male subjects after a single oral administration of \[14C\]HPP737.
Participants will:
1. Take Investigational product once
2. Stay in the clinic about 7 days for checkups and tests
3. Report their symptoms
1. Quantitative analysis of the total amount of radioactivity in excreta (urine and feces) of male healthy subjects after oral administration of \[14C\]HPP737, to obtain the cumulative excretion rate and main excretion routes of human radioactivity;
2. To identify the main metabolites in the offspring of \[14C\]HPP737 in healthy male subjects, and to determine the main biotransformation pathway and main metabolite structure;
3. To investigate the distribution of total radioactivity in whole blood and plasma and the pharmacokinetics of total plasma radioactivity in healthy male subjects after a single oral administration of \[14C\]HPP737.
Participants will:
1. Take Investigational product once
2. Stay in the clinic about 7 days for checkups and tests
3. Report their symptoms
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: