Clinical trial NCT06798519: Relative Bioavailability Study of HNC364 Injectable Suspension
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Parkinson&#39;s Disease (PD)
Lead sponsor: Guangzhou Henovcom Bioscience Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2025-01-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. 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.
2. Refer to Section 6.4 (all sub-sections) for full details regarding study restrictions and requirements.
3. Be able to complete the study according to the requirements of the study protocol.
4. Healthy adult subjects aged 18-55 (including boundary value), both male and female.
5. 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).
6. Vital signs, physical examination, laboratory tests, and electrocardiogram, etc. are normal, or abnormal results are judged by the Investigator to be clinically insignificant.
7. 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.
8. 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.

Exclusion Criteria:

1. 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.
2. Any history of suicide or at high risk for suicide assessment at screening.
3. The subject has a history of severe allergy or allergy to the study drug and any of its components or related excipients.
4. 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).
5. 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.
6. 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.
7. 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.
8. Positive blood screen for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
9. 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.
10. Any prescription drug, over-the-counter drug, any vitamin product or Chinese herbal medicine used within 2 weeks before the study drug administration.
11. 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.
12. Had consumed chocolate, any food or beverage containing caffeine or xanthine-rich within 72 hours before the study drug administration.
13. Taking any alcoholic product within 48 hours before the administration.
14. 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.
15. Participated in other clinical trials within 30 days prior to study drug administration.
16. Acute disease or concomitant medication from the signing of informed consent form to the study drug administration.
17. Lactating women or those with positive serum pregnancy results.
18. The researchers believe that subjects with other factors that are not suitable to participate in this study.

Primary outcomes:
measure: Area under the concentration-time curve (AUC) from time 0 to dose interval (AUCτ)
timeFrame: Day 1 to 56 days post dose
measure: Number of Participants With Treatment Emergent Adverse Events
timeFrame: Day 1 to 56 days post dose
Secondary outcomes:
measure: maximum observed concentration (Cmax)
timeFrame: Day 1 to 56 days post dose
measure: time to maximum concentration (Tmax)
timeFrame: Day 1 to 56 days post dose
measure: Time at which half the drug has been eliminated (t½)
timeFrame: Day 1 to 56 days post dose
measure: Mean residence time (MRT)
timeFrame: Day 1 to 56 days post dose
measure: Apparent total clearance for extravascular administration (CL/F)
timeFrame: Day 1 to 56 days post dose
measure: Apparent volume of distribution during terminal phase (Vz/F)
timeFrame: Day 1 to 56 days post dose
measure: Elimination rate constant (Kel)
timeFrame: Day 1 to 56 days post dose
measure: Steady-state trough concentration (Css_min)
timeFrame: Day 1 to 56 days post dose
measure: Average steady-state blood drug concentration (Css-av)
timeFrame: Day 1 to 56 days post dose
measure: Steady-state peak concentration (Css_min)
timeFrame: Day 1 to 56 days post dose
measure: Platelet MAO-B activity
timeFrame: Day 1 to 56 days post dose
Other outcomes:
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