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

PHASE1CompletedINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

August 22, 2022

Primary Completion Date

April 15, 2024

Study Completion Date

April 15, 2024

Conditions
Parkinson's Disease
Interventions
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.

Trial Locations (1)

07094

Frontage Clinical Services, Inc., Secaucus

All Listed Sponsors
lead

Guangzhou Henovcom Bioscience Co. Ltd.

INDUSTRY