NCT06798519

Relative Bioavailability Study of HNC364 Injectable Suspension

A Relative Bioavailability Study of HNC364 Following Intramuscular Injections Vs. AZILECT® (Rasagiline Tablet) Following Oral Administration At the Steady-State in Healthy Adult Subjects

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Guangzhou Henovcom Bioscience Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

HNC364 is a new pro-drug of rasagiline as a long-acting injection for deep IM deltoid injection, for the treatment of Parkinson"s disease (PD). As a pro-drug of rasagiline, HNC364 will readily and completely convert to rasagiline after the IM administration. This is a non-randomized, open-label, Phase 1 study to evaluate the relative bioavailability of HNC364 injectable suspension relative to AZILECT® (rasagiline tablets), to assess the safety and tolerability of multiple IM dose HNC364 injectable suspension dose administration in healthy adult subjects.

Conditions

• Parkinson's Disease (PD)

Interventions

Type	Name	Description
DRUG	HNC364 Injectable Suspension	Subjects in HNC364 cohort will receive a deep IM injection of HNC364 injectable suspension in the deltoid muscle at a dose of 60 mg every 4 weeks for 4 repeated doses. Subjects will be allowed to leave the clinical site the next day after receiving each dose and return to clinical site on 7 days, 14 days and 28 days (before next administration) after each dose for safety and tolerability assessments. Besides, subjects will return to the clinical site on 4 days after the first dose and the last dose due to PK and PD blood sample collections.
DRUG	Rasagiline Tablets	Subjects in rasagiline tablets cohort will receive 1 mg of rasagiline tablets orally once daily for 20 days, followed by 2 mg once daily for 5 days. Subjects will remain domiciled at the clinic stay until Day 26 and have a follow-up visit on Day 29 due to PK and PD blood sample collections

Timeline

• Start date: 2025-05-01
• Primary completion: 2026-05-31
• Completion: 2026-06-30
• First posted: 2025-01-29
• Last updated: 2025-01-29

Regulatory

• FDA-regulated drug study