Parkinson's Disease (PD)Phase 1NCT06798519
Relative Bioavailability Study of HNC364 Injectable Suspension
A Phase 1 study testing HNC364 Injectable Suspension and Rasagiline Tablets in people with Parkinson's Disease (PD), run by Guangzhou Henovcom Bioscience Co. Ltd. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease (PD)
- What is being tested?
- HNC364 Injectable Suspension and Rasagiline Tablets
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2026to 31 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Capable of understanding the written informed consent document; willingly provides valid, signed written informed consent; willing and able to comply with the schedule, requirements, and restrictions of the study. Are capable of giving informed consent and complying with study procedures.
- Refer to Section 6.4 (all sub-sections) for full details regarding study restrictions and requirements.
- Be able to complete the study according to the requirements of the study protocol.
- Healthy adult subjects aged 18-55 (including boundary value), both male and female.
- The body weight of male subjects shall not be less than 50 kg and that of female subjects shall not be less than 45 kg. BMI = body weight (kg)/height2 (M2), and the body mass index is in the range of 18 ~ 32 kg/m2 (including the critical value).
- Vital signs, physical examination, laboratory tests, and electrocardiogram, etc. are normal, or abnormal results are judged by the Investigator to be clinically insignificant.
- Nonsmoker, those who did not use other nicotine-containing products, those who quit smoking or stopped using other nicotine-containing products 3 months before the study drug administration.
- Female or male subjects with potential fertility must agree to use an effective contraceptive method from the start of signing informed consent form until 6 months after the study drug administration to avoid pregnancy or make their partner pregnant.
Who cannot join
- Prior to screening, subjects had clinically significant disease history as determined by the Investigator, including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, neoplastic, pulmonary, immunological, psychiatric, cardio cerebrovascular disease or any reported history of sleep disorder.
- Any history of suicide or at high risk for suicide assessment at screening.
- The subject has a history of severe allergy or allergy to the study drug and any of its components or related excipients.
- Prior to screening, those who have a history of gastrointestinal, liver and kidney diseases or surgery that potentially affect the absorption, distribution, metabolism and excretion of the study drug (except for uncomplicated appendectomy and hernia repair).
- A history of alcoholism (alcoholism is defined as drinking 14 units of alcohol per week: 1 unit = 285 mL of beer, 25 mL of spirits, or 100 mL of wine) or positive alcohol breath test during the screening period.
- Those who had a history of drug abuse or used drugs within 2 years before screening or those who were positive for urinary drug screening during the screening period.
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- Subjects who had a history of smoking or used other nicotine-containing products within 3 months before the study drug administration, or who were positive for urine nicotine test during screening.
- Positive blood screen for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
- Strong inhibitors and/or inducers of liver metabolizing enzymes (CYP1A2, 2A6, 2C8, 2C19, 3A4 and 3A5), strong inhibitors of liver metabolizing enzymes such as ciprofloxacin, clopidogrel, itraconazole, ketoconazole, ritonavir, acerbicin, etc., and strong inducers of liver metabolizing enzymes such as rifampicin, carbamazepine, phenytoin sodium, St. John's wort, etc. were used within 4 weeks before the study drug administration.
- Any prescription drug, over-the-counter drug, any vitamin product or Chinese herbal medicine used within 2 weeks before the study drug administration.
- Had consumed a special diet (including pitaya, mango, grapefruit, or certain foods containing high amounts of tyramine, etc.) or had vigorous exercise, or other factors affecting drug absorption, distribution, metabolism, excretion, etc., within 2 weeks before the administration.
- Had consumed chocolate, any food or beverage containing caffeine or xanthine-rich within 72 hours before the study drug administration.
- Taking any alcoholic product within 48 hours before the administration.
- Donation of plasma within 30 days, or donation of blood or massive blood loss (≥ 400 mL) within 60 days, or donation of bone marrow or peripheral stem cells within 90 days before the study drug administration.
- Participated in other clinical trials within 30 days prior to study drug administration.
- Acute disease or concomitant medication from the signing of informed consent form to the study drug administration.
- Lactating women or those with positive serum pregnancy results.
- The researchers believe that subjects with other factors that are not suitable to participate in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Frontage Clinical Services, Inc.
Secaucus, New Jersey, 07094
About this study
Official title: A Relative Bioavailability Study of HNC364 Following Intramuscular Injections vs. AZILECT® (Rasagiline Tablet) Following Oral Administration at the Steady-State in Healthy Adult Subjects
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)
- Being tested
- HNC364 Injectable Suspension, Rasagiline Tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HNC364 Injectable SuspensionDrug
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.
Rasagiline TabletsDrug
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
| Study group | Role | What they receive |
|---|---|---|
| HNC364 Injectable Suspension | Experimental | 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. Receives: Drug: HNC364 Injectable Suspension |
| Rasagiline Tablets | Active comparator | 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 Receives: Drug: Rasagiline Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve (AUC) from time 0 to dose interval (AUCτ)
The relative bioavailability of HNC364 injectable suspension and rasagiline tablets at the steady-state will be calculated by comparing the following PK parameters of rasagiline in both formulations.
Due to the negligible plasma concentrations of HNC364 observed following intramuscular injection, the relative bioavailability calculations will be based on the assumption of complete conversion of HNC364 to rasagiline in vivo. To facilitate this comparison, the administered dose of HNC364 (60 mg) will be converted to an equivalent dose of rasagiline based on their respective molecular weights: 60 mg * 171.24 / 624.91 = 16.44 mg.
Measured: Day 1 to 56 days post dose
Number of Participants With Treatment Emergent Adverse Events
The following assessments will be used to evaluate the safety of HNC364 and rasagiline: monitoring and assessment of adverse events (AEs) and concomitant medications; 12-lead electrocardiograms (ECGs); vital sign measurements (including blood pressure, heart rate, respiratory rate, and oral temperature); clinical laboratory test results (including serum chemistry, hematology, coagulation, and urinalysis); physical examinations and injection site reactions.
Measured: Day 1 to 56 days post dose
Secondary outcomes (11)
maximum observed concentration (Cmax)
HNC364 cohorts Dose 1: Pre dose (within 60 min); post dose at 4 (±5 min) and 24 (±60 min) hour; post dose at Days 4, 7, 10 and 14.
Dose 2 and 3: Pre dose (within 60 min) Dose 4: Pre dose (within 60 min); post dose at 24 hour (±60 min); post dose at Days 4, 7, 10, 14, 29 and 56.
rasagiline tablets cohort Study Day 1: pre dose (up to 30 min) and 0.5, 1 hour (±1 min), 2, 4 hours (±2 min), 6, 12 hours (±5 min) and 24 hours (±30 min) post dose. The 24 hour post dose blood PK samples for Days 1 should be taken before dosing on Days 2.
Study Day 4: pre dose (up to 30 min); Study Day 7: pre dose (up to 30 min) and 1 hours (±1 min) post dose Study Days 10 and 14: pre dose (up to 30 min); Study Day 20: pre dose (up to 30 min) and 0.5, 1 hour (±1 min), 2, 4 hours (±2 min), 6, 12 hours (±5 min) and 24 hours (±30 min) post dose. The 24 hour post dose blood PK samples for Days 20 should be taken before dosing on Days 21.
Study Day 21: 1 hours (±1 min) post dose Study Day 25: pre dose (up to 30 min)
Measured: Day 1 to 56 days post dose
time to maximum concentration (Tmax)
HNC364 cohorts Dose 1: Pre dose (within 60 min); post dose at 4 (±5 min) and 24 (±60 min) hour; post dose at Days 4, 7, 10 and 14. Dose 2 and 3: Pre dose (within 60 min) Dose 4: Pre dose (within 60 min); post dose at 24 hour (±60 min); post dose at Days 4, 7, 10, 14, 29 and 56. rasagiline tablets cohort Study Day 1: pre dose (up to 30 min) and 0.5, 1 hour (±1 min), 2, 4 hours (±2 min), 6, 12 hours (±5 min) and 24 hours (±30 min) post dose. The 24 hour post dose blood PK samples for Days 1 should be taken before dosing on Days 2. Study Day 4: pre dose (up to 30 min); Study Day 7: pre dose (up to 30 min) and 1 hours (±1 min) post dose Study Days 10 and 14: pre dose (up to 30 min); Study Day 20: pre dose (up to 30 min) and 0.5, 1 hour (±1 min), 2, 4 hours (±2 min), 6, 12 hours (±5 min) and 24 hours (±30 min) post dose. The 24 hour post dose blood PK samples for Days 20 should be taken before dosing on Days 21. Study Day 21: 1 hours (±1 min) post dose Study Day 25: pre dose (up to 30 min)
Measured: Day 1 to 56 days post dose
Time at which half the drug has been eliminated (t½)
HNC364 cohorts Dose 1: Pre dose (within 60 min); post dose at 4 (±5 min) and 24 (±60 min) hour; post dose at Days 4, 7, 10 and 14. Dose 2 and 3: Pre dose (within 60 min) Dose 4: Pre dose (within 60 min); post dose at 24 hour (±60 min); post dose at Days 4, 7, 10, 14, 29 and 56. rasagiline tablets cohort Study Day 1: pre dose (up to 30 min) and 0.5, 1 hour (±1 min), 2, 4 hours (±2 min), 6, 12 hours (±5 min) and 24 hours (±30 min) post dose. The 24 hour post dose blood PK samples for Days 1 should be taken before dosing on Days 2. Study Day 4: pre dose (up to 30 min); Study Day 7: pre dose (up to 30 min) and 1 hours (±1 min) post dose Study Days 10 and 14: pre dose (up to 30 min); Study Day 20: pre dose (up to 30 min) and 0.5, 1 hour (±1 min), 2, 4 hours (±2 min), 6, 12 hours (±5 min) and 24 hours (±30 min) post dose. The 24 hour post dose blood PK samples for Days 20 should be taken before dosing on Days 21. Study Day 21: 1 hours (±1 min) post dose Study Day 25: pre dose (up to 30 min)
Measured: Day 1 to 56 days post dose
Mean residence time (MRT)
HNC364 cohorts Dose 1: Pre dose (within 60 min); post dose at 4 (±5 min) and 24 (±60 min) hour; post dose at Days 4, 7, 10 and 14. Dose 2 and 3: Pre dose (within 60 min) Dose 4: Pre dose (within 60 min); post dose at 24 hour (±60 min); post dose at Days 4, 7, 10, 14, 29 and 56. rasagiline tablets cohort Study Day 1: pre dose (up to 30 min) and 0.5, 1 hour (±1 min), 2, 4 hours (±2 min), 6, 12 hours (±5 min) and 24 hours (±30 min) post dose. The 24 hour post dose blood PK samples for Days 1 should be taken before dosing on Days 2. Study Day 4: pre dose (up to 30 min); Study Day 7: pre dose (up to 30 min) and 1 hours (±1 min) post dose Study Days 10 and 14: pre dose (up to 30 min); Study Day 20: pre dose (up to 30 min) and 0.5, 1 hour (±1 min), 2, 4 hours (±2 min), 6, 12 hours (±5 min) and 24 hours (±30 min) post dose. The 24 hour post dose blood PK samples for Days 20 should be taken before dosing on Days 21. Study Day 21: 1 hours (±1 min) post dose Study Day 25: pre dose (up to 30 min)
Measured: Day 1 to 56 days post dose
Apparent total clearance for extravascular administration (CL/F)
HNC364 cohorts Dose 1: Pre dose (within 60 min); post dose at 4 (±5 min) and 24 (±60 min) hour; post dose at Days 4, 7, 10 and 14. Dose 2 and 3: Pre dose (within 60 min) Dose 4: Pre dose (within 60 min); post dose at 24 hour (±60 min); post dose at Days 4, 7, 10, 14, 29 and 56. rasagiline tablets cohort Study Day 1: pre dose (up to 30 min) and 0.5, 1 hour (±1 min), 2, 4 hours (±2 min), 6, 12 hours (±5 min) and 24 hours (±30 min) post dose. The 24 hour post dose blood PK samples for Days 1 should be taken before dosing on Days 2. Study Day 4: pre dose (up to 30 min); Study Day 7: pre dose (up to 30 min) and 1 hours (±1 min) post dose Study Days 10 and 14: pre dose (up to 30 min); Study Day 20: pre dose (up to 30 min) and 0.5, 1 hour (±1 min), 2, 4 hours (±2 min), 6, 12 hours (±5 min) and 24 hours (±30 min) post dose. The 24 hour post dose blood PK samples for Days 20 should be taken before dosing on Days 21. Study Day 21: 1 hours (±1 min) post dose Study Day 25: pre dose (up to 30 min)
Measured: Day 1 to 56 days post dose
Apparent volume of distribution during terminal phase (Vz/F)
HNC364 cohorts Dose 1: Pre dose (within 60 min); post dose at 4 (±5 min) and 24 (±60 min) hour; post dose at Days 4, 7, 10 and 14. Dose 2 and 3: Pre dose (within 60 min) Dose 4: Pre dose (within 60 min); post dose at 24 hour (±60 min); post dose at Days 4, 7, 10, 14, 29 and 56. rasagiline tablets cohort Study Day 1: pre dose (up to 30 min) and 0.5, 1 hour (±1 min), 2, 4 hours (±2 min), 6, 12 hours (±5 min) and 24 hours (±30 min) post dose. The 24 hour post dose blood PK samples for Days 1 should be taken before dosing on Days 2. Study Day 4: pre dose (up to 30 min); Study Day 7: pre dose (up to 30 min) and 1 hours (±1 min) post dose Study Days 10 and 14: pre dose (up to 30 min); Study Day 20: pre dose (up to 30 min) and 0.5, 1 hour (±1 min), 2, 4 hours (±2 min), 6, 12 hours (±5 min) and 24 hours (±30 min) post dose. The 24 hour post dose blood PK samples for Days 20 should be taken before dosing on Days 21. Study Day 21: 1 hours (±1 min) post dose Study Day 25: pre dose (up to 30 min)
Measured: Day 1 to 56 days post dose
Elimination rate constant (Kel)
HNC364 cohorts Dose 1: Pre dose (within 60 min); post dose at 4 (±5 min) and 24 (±60 min) hour; post dose at Days 4, 7, 10 and 14. Dose 2 and 3: Pre dose (within 60 min) Dose 4: Pre dose (within 60 min); post dose at 24 hour (±60 min); post dose at Days 4, 7, 10, 14, 29 and 56. rasagiline tablets cohort Study Day 1: pre dose (up to 30 min) and 0.5, 1 hour (±1 min), 2, 4 hours (±2 min), 6, 12 hours (±5 min) and 24 hours (±30 min) post dose. The 24 hour post dose blood PK samples for Days 1 should be taken before dosing on Days 2. Study Day 4: pre dose (up to 30 min); Study Day 7: pre dose (up to 30 min) and 1 hours (±1 min) post dose Study Days 10 and 14: pre dose (up to 30 min); Study Day 20: pre dose (up to 30 min) and 0.5, 1 hour (±1 min), 2, 4 hours (±2 min), 6, 12 hours (±5 min) and 24 hours (±30 min) post dose. The 24 hour post dose blood PK samples for Days 20 should be taken before dosing on Days 21. Study Day 21: 1 hours (±1 min) post dose Study Day 25: pre dose (up to 30 min)
Measured: Day 1 to 56 days post dose
Steady-state trough concentration (Css_min)
HNC364 cohorts Dose 1: Pre dose (within 60 min); post dose at 4 (±5 min) and 24 (±60 min) hour; post dose at Days 4, 7, 10 and 14. Dose 2 and 3: Pre dose (within 60 min) Dose 4: Pre dose (within 60 min); post dose at 24 hour (±60 min); post dose at Days 4, 7, 10, 14, 29 and 56. rasagiline tablets cohort Study Day 1: pre dose (up to 30 min) and 0.5, 1 hour (±1 min), 2, 4 hours (±2 min), 6, 12 hours (±5 min) and 24 hours (±30 min) post dose. The 24 hour post dose blood PK samples for Days 1 should be taken before dosing on Days 2. Study Day 4: pre dose (up to 30 min); Study Day 7: pre dose (up to 30 min) and 1 hours (±1 min) post dose Study Days 10 and 14: pre dose (up to 30 min); Study Day 20: pre dose (up to 30 min) and 0.5, 1 hour (±1 min), 2, 4 hours (±2 min), 6, 12 hours (±5 min) and 24 hours (±30 min) post dose. The 24 hour post dose blood PK samples for Days 20 should be taken before dosing on Days 21. Study Day 21: 1 hours (±1 min) post dose Study Day 25: pre dose (up to 30 min)
Measured: Day 1 to 56 days post dose
Average steady-state blood drug concentration (Css-av)
HNC364 cohorts Dose 1: Pre dose (within 60 min); post dose at 4 (±5 min) and 24 (±60 min) hour; post dose at Days 4, 7, 10 and 14. Dose 2 and 3: Pre dose (within 60 min) Dose 4: Pre dose (within 60 min); post dose at 24 hour (±60 min); post dose at Days 4, 7, 10, 14, 29 and 56. rasagiline tablets cohort Study Day 1: pre dose (up to 30 min) and 0.5, 1 hour (±1 min), 2, 4 hours (±2 min), 6, 12 hours (±5 min) and 24 hours (±30 min) post dose. The 24 hour post dose blood PK samples for Days 1 should be taken before dosing on Days 2. Study Day 4: pre dose (up to 30 min); Study Day 7: pre dose (up to 30 min) and 1 hours (±1 min) post dose Study Days 10 and 14: pre dose (up to 30 min); Study Day 20: pre dose (up to 30 min) and 0.5, 1 hour (±1 min), 2, 4 hours (±2 min), 6, 12 hours (±5 min) and 24 hours (±30 min) post dose. The 24 hour post dose blood PK samples for Days 20 should be taken before dosing on Days 21. Study Day 21: 1 hours (±1 min) post dose Study Day 25: pre dose (up to 30 min)
Measured: Day 1 to 56 days post dose
Steady-state peak concentration (Css_min)
HNC364 cohorts Dose 1: Pre dose (within 60 min); post dose at 4 (±5 min) and 24 (±60 min) hour; post dose at Days 4, 7, 10 and 14. Dose 2 and 3: Pre dose (within 60 min) Dose 4: Pre dose (within 60 min); post dose at 24 hour (±60 min); post dose at Days 4, 7, 10, 14, 29 and 56. rasagiline tablets cohort Study Day 1: pre dose (up to 30 min) and 0.5, 1 hour (±1 min), 2, 4 hours (±2 min), 6, 12 hours (±5 min) and 24 hours (±30 min) post dose. The 24 hour post dose blood PK samples for Days 1 should be taken before dosing on Days 2. Study Day 4: pre dose (up to 30 min); Study Day 7: pre dose (up to 30 min) and 1 hours (±1 min) post dose Study Days 10 and 14: pre dose (up to 30 min); Study Day 20: pre dose (up to 30 min) and 0.5, 1 hour (±1 min), 2, 4 hours (±2 min), 6, 12 hours (±5 min) and 24 hours (±30 min) post dose. The 24 hour post dose blood PK samples for Days 20 should be taken before dosing on Days 21. Study Day 21: 1 hours (±1 min) post dose Study Day 25: pre dose (up to 30 min)
Measured: Day 1 to 56 days post dose
Platelet MAO-B activity
HNC364 cohorts Dose 1: Pre dose (within 60 min); post dose at 4 (±5 min) and 24 (±60 min) hour; post dose at Days 4, 7, 10 and 14. Dose 2 and 3: Pre dose (within 60 min) Dose 4: Pre dose (within 60 min); post dose at 24 hour (±60 min); post dose at Days 4, 7, 10, 14, 29 and 56. rasagiline tablets cohort Study Day 1: pre dose (up to 30 min) and 0.5, 1 hour (±1 min), 2, 4 hours (±2 min), 6, 12 hours (±5 min) and 24 hours (±30 min) post dose. The 24 hour post dose blood PK samples for Days 1 should be taken before dosing on Days 2. Study Day 4: pre dose (up to 30 min); Study Day 7: pre dose (up to 30 min) and 1 hours (±1 min) post dose Study Days 10 and 14: pre dose (up to 30 min); Study Day 20: pre dose (up to 30 min) and 0.5, 1 hour (±1 min), 2, 4 hours (±2 min), 6, 12 hours (±5 min) and 24 hours (±30 min) post dose. The 24 hour post dose blood PK samples for Days 20 should be taken before dosing on Days 21. Study Day 21: 1 hours (±1 min) post dose Study Day 25: pre dose (up to 30 min)
Measured: Day 1 to 56 days post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start8 May 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's Disease (PD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Henovcom Bioscience Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Frontage Clinical Services, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06798519
- Sponsor's protocol ID
- HNC364-A102
- Status last verified
- May 2026
- First submitted
- 17 Jan 2025
- Last updated
- 2 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Relative Bioavailability Study of HNC364 Following Intramuscular Injections vs. AZILECT® (Rasagiline Tablet) Following Oral Administration at the Steady-State in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT06798519
- Acronym / sponsor ID
- HNC364-A102
- Conditions
- Parkinson's Disease (PD)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Guangzhou Henovcom Bioscience Co. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Frontage Clinical Services, Inc.
- Study start
- 8 May 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HNC364 Injectable Suspension | Experimental | Drug: HNC364 Injectable SuspensionSubjects 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. |
| Rasagiline Tablets | Active comparator | Drug: Rasagiline TabletsSubjects 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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Capable of understanding the written informed consent document; willingly provides valid, signed written informed consent; willing and able to comply with the schedule, requirements, and restrictions of the study. Are capable of giving informed consent and complying with study procedures.
- Refer to Section 6.4 (all sub-sections) for full details regarding study restrictions and requirements.
- Be able to complete the study according to the requirements of the study protocol.
- Healthy adult subjects aged 18-55 (including boundary value), both male and female.
- The body weight of male subjects shall not be less than 50 kg and that of female subjects shall not be less than 45 kg. BMI = body weight (kg)/height2 (M2), and the body mass index is in the range of 18 ~ 32 kg/m2 (including the critical value).
Key exclusion criteria (18 listed)
- Prior to screening, subjects had clinically significant disease history as determined by the Investigator, including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, neoplastic, pulmonary, immunological, psychiatric, cardio cerebrovascular disease or any reported history of sleep disorder.
- Any history of suicide or at high risk for suicide assessment at screening.
- The subject has a history of severe allergy or allergy to the study drug and any of its components or related excipients.
- Prior to screening, those who have a history of gastrointestinal, liver and kidney diseases or surgery that potentially affect the absorption, distribution, metabolism and excretion of the study drug (except for uncomplicated appendectomy and hernia repair).
- A history of alcoholism (alcoholism is defined as drinking 14 units of alcohol per week: 1 unit = 285 mL of beer, 25 mL of spirits, or 100 mL of wine) or positive alcohol breath test during the screening period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HNC364 Injectable SuspensionSubjects 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 | HNC364 Injectable Suspension |
| Rasagiline TabletsSubjects 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 | Rasagiline Tablets |
Primary outcome
Area under the concentration-time curve (AUC) from time 0 to dose interval (AUCτ)
Time frame: Day 1 to 56 days post dose
The relative bioavailability of HNC364 injectable suspension and rasagiline tablets at the steady-state will be calculated by comparing the following PK parameters of rasagiline in both formulations. Due to the negligible plasma concentrations of HNC364 observed following intramuscular injection, the relative bioavailability calculations will be based on the assumption of complete conversion of HNC364 to rasagiline in vivo. To facilitate this comparison, the administered dose of HNC364 (60 mg) will be converted to an equivalent dose of rasagiline based on their respective molecular weights: 60 mg * 171.24 / 624.91 = 16.44 mg.
Number of Participants With Treatment Emergent Adverse Events
Time frame: Day 1 to 56 days post dose
The following assessments will be used to evaluate the safety of HNC364 and rasagiline: monitoring and assessment of adverse events (AEs) and concomitant medications; 12-lead electrocardiograms (ECGs); vital sign measurements (including blood pressure, heart rate, respiratory rate, and oral temperature); clinical laboratory test results (including serum chemistry, hematology, coagulation, and urinalysis); physical examinations and injection site reactions.
11 secondary outcomes
maximum observed concentration (Cmax)
Time frame: Day 1 to 56 days post dose
time to maximum concentration (Tmax)
Time frame: Day 1 to 56 days post dose
Time at which half the drug has been eliminated (t½)
Time frame: Day 1 to 56 days post dose
Mean residence time (MRT)
Time frame: Day 1 to 56 days post dose
Apparent total clearance for extravascular administration (CL/F)
Time frame: Day 1 to 56 days post dose
Apparent volume of distribution during terminal phase (Vz/F)
Time frame: Day 1 to 56 days post dose
Elimination rate constant (Kel)
Time frame: Day 1 to 56 days post dose
Steady-state trough concentration (Css_min)
Time frame: Day 1 to 56 days post dose
Average steady-state blood drug concentration (Css-av)
Time frame: Day 1 to 56 days post dose
Steady-state peak concentration (Css_min)
Time frame: Day 1 to 56 days post dose
Platelet MAO-B activity
Time frame: Day 1 to 56 days post dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HNC364 Injectable Suspension and Rasagiline Tablets in people with Parkinson's Disease (PD), run by Guangzhou Henovcom Bioscience Co. Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the concentration-time curve (AUC) from time 0 to dose interval (AUCτ) (time frame: Day 1 to 56 days post dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.