NCT06852092

Study on Mass Balance of [14C]HSK39297 in Healthy Chinese Adult Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Haisco Pharmaceutical Group Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

To evaluate the absorption, metabolism and excretion in healthy Chinese male subjects after a single oral dose of \[14C\]HSK39297

Detailed description

1. To quantitatively analyze the total radioactivity in excreta after oral administration of \[14C\]HHSK39297 in healthy subjects, obtain the data on human radioactivity excretion rate and determine the main excretion pathways 2. To quantitatively analyze the total radioactivity in whole blood and plasma in healthy subjects after oral administration of \[14C\]HSK39297, to obtain the pharmacokinetics of total radioactivity in plasma and to investigate the distribution of total radioactivity in whole blood and plasma 3. To obtain the radioactive metabolite profile in plasma, urine, and feces after oral administration of \[14C\]HSK39297 in healthy subjects, to identify the main metabolites and to determine the metabolism and elimination pathways

Conditions

• Paroxysmal Nocturnal Hemoglobinuria (PNH)

Interventions

Type	Name	Description
DRUG	Carbon-14 labeled HSK39297	Dose A

Timeline

• Start date: 2024-09-09
• Primary completion: 2024-09-27
• Completion: 2024-12-10
• First posted: 2025-02-28
• Last updated: 2025-02-28

Locations

1 site across 1 country: China