Actively Recruiting
Relative Bioavailability Study of HNC364 Injectable Suspension
Led by Guangzhou Henovcom Bioscience Co. Ltd. · Updated on 2026-05-12
30
Participants Needed
1
Research Sites
33 weeks
Total Duration
On this page
Sponsors
G
Guangzhou Henovcom Bioscience Co. Ltd.
Lead Sponsor
F
Frontage Clinical Services, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Relative Bioavailability Study of HNC364 Injectable Suspension
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and willingly sign informed consent
- Willing and able to follow study schedule and requirements
- Able to complete the study according to protocol
- Healthy adults aged 18 to 55 years, male or female
- Male body weight at least 50 kg; female body weight at least 45 kg; BMI between 18 and 32 kg/m2
- Normal vital signs, physical exam, lab tests, and ECG or abnormalities deemed not clinically significant
- Nonsmokers or those who quit nicotine use at least 3 months before dosing
- Agree to use effective contraception from consent until 6 months after dosing
You will not qualify if you...
- History of significant diseases including gastrointestinal, renal, hepatic, neurological, hematological, endocrine, neoplastic, pulmonary, immunological, psychiatric, cardio cerebrovascular disease, or sleep disorders
- History of suicide or high suicide risk
- Severe allergy or allergy to study drug or its components
- History of gastrointestinal, liver, or kidney diseases or surgeries affecting drug metabolism (except uncomplicated appendectomy and hernia repair)
- History of alcoholism or positive alcohol breath test at screening
- History of drug abuse or recent drug use within 2 years, or positive drug screening
- Smoking or nicotine use within 3 months before dosing or positive urine nicotine test
- Positive blood test for HIV, hepatitis B, or hepatitis C
- Use of strong liver enzyme inhibitors or inducers within 4 weeks before dosing
- Use of any prescription, OTC drugs, vitamins, or herbal medicines within 2 weeks before dosing
- Special diet, vigorous exercise, or other factors affecting drug metabolism within 2 weeks before dosing
- Consumption of chocolate, caffeine, or xanthine-rich foods/beverages within 72 hours before dosing
- Alcohol intake within 48 hours before dosing
- Blood or plasma donation or major blood loss within specified timeframes before dosing
- Participation in other clinical trials within 30 days before dosing
- Acute disease or medication use from consent signing to dosing
- Lactating women or positive pregnancy test
- Other factors deemed unsuitable by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Frontage Clinical Services, Inc.
Secaucus, New Jersey, United States, 07094
Actively Recruiting
Research Team
Y
Yan Liu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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