Relative Bioavailability Study of HNC364 Injectable Suspension (NCT06798519) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Relative Bioavailability Study of HNC364 Injectable Suspension
United States30 participantsStarted 2026-05-08
Plain-language 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.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1 trial measuring how the body absorbs HNC364 injectable suspension, what does that mean for what we actually know so far about whether it helps with Parkinson's symptoms versus just understanding how the drug behaves?
2The trial is actively enrolling but no longer recruiting new participants — is there any chance I could still be considered, or should we focus on finding a different study or treatment path right now?
3This trial is measuring treatment-emergent adverse events as a primary outcome, which suggests they're still learning about the safety profile — what kinds of side effects have been reported so far, and how does that risk compare to my current or standard treatment options?
4Since this involves an injectable suspension rather than a pill, how would the dosing schedule and injection requirements fit into my daily life, and is that something worth weighing against other available Parkinson's treatments?
5Given that this is an early-phase bioavailability study rather than a trial testing whether HNC364 actually improves Parkinson's outcomes, would you recommend I consider this versus a later-phase trial that's already established some evidence of benefit?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Area under the concentration-time curve (AUC) from time 0 to dose interval (AUCτ)
Timeframe: Day 1 to 56 days post dose
2
Number of Participants With Treatment Emergent Adverse Events
. 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.
Exclusion criteria
. 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.
. 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.