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Relative Bioavailability Study of HNC364 Injectable Suspension

NCT06798519 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-05-12

No results posted yet for this study

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

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

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.

Sponsors & Collaborators

  • Frontage Clinical Services, Inc.

    collaborator UNKNOWN

  • Guangzhou Henovcom Bioscience Co. Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-08
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06798519 on ClinicalTrials.gov