NCT05523570

A Study to Evaluate the Safety, Tolerability, PK and PD of HNC364 Injectable Suspension

Phase 1, Non-randomized, Single Ascending Doses (SAD) Study Following Single Injection in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HNC364 Injectable Suspension

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Guangzhou Henovcom Bioscience Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a non-randomized, dose-escalation first-in-human study to evaluate the safety, tolerability, PK, and PD of HNC364 following intramuscular administration of single ascending doses.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	HNC364	2 subjects (both male and female) to receive 20 mg HNC364 intramuscular administration to evaluate the safety and tolerability of HNC364 injectable suspension. Then 8 subjects are planned for enrollment in each cohort (the ratio of male to female is as close as possible) to receive 20 mg HNC364 intramuscular administration. The proposed dose levels for use were determined to be appropriate based on the collective nonclinical data (pharmacology and toxicology) for HNC364 and the nonclinical and clinical data of the marketed drug rasagiline.
DRUG	HNC364	8 subjects are planned for enrollment in each cohort (the ratio of male to female is as close as possible) to receive 40 mg HNC364 intramuscular administration. The proposed dose levels for use were determined to be appropriate based on the collective nonclinical data (pharmacology and toxicology) for HNC364 and the nonclinical and clinical data of the marketed drug rasagiline.
DRUG	HNC364	8 subjects are planned for enrollment in each cohort (the ratio of male to female is as close as possible) to receive 60 mg HNC364 intramuscular administration. The proposed dose levels for use were determined to be appropriate based on the collective nonclinical data (pharmacology and toxicology) for HNC364 and the nonclinical and clinical data of the marketed drug rasagiline.
DRUG	HNC364	8 subjects are planned for enrollment in each cohort (the ratio of male to female is as close as possible) to receive 80 mg HNC364 intramuscular administration. The proposed dose levels for use were determined to be appropriate based on the collective nonclinical data (pharmacology and toxicology) for HNC364 and the nonclinical and clinical data of the marketed drug rasagiline.

Timeline

• Start date: 2022-08-22
• Primary completion: 2024-04-15
• Completion: 2024-04-15
• First posted: 2022-08-31
• Last updated: 2024-09-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study