Parkinson's DiseasePhase 1NCT05523570
A Study to Evaluate the Safety, Tolerability, PK and PD of HNC364 Injectable Suspension
A Phase 1 study testing HNC364 in people with Parkinson's Disease, run by Guangzhou Henovcom Bioscience Co. Ltd. at 1 site in United States.
Trial summary
This is a non-randomized, dose-escalation first-in-human study to evaluate the safety, tolerability, PK, and PD of HNC364 following intramuscular administration of single ascending doses. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- HNC364
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2022to 15 Apr 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects who meet any of the following criteria must be excluded from the study:
- 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 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.
Show all 22Show fewer
- 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.
- Prohibitions and Restrictions：
- Subjects must be willing to adhere to the following prohibitions and restrictions during the study (until final discharge from the clinic):
- Use of tobacco- or nicotine-containing products, in any form, is prohibited within 3 months prior to study drug administration on Day 1 until after the EOS visit.
- Within 4 weeks prior to study drug administration until 30 days post dose, any drugs known to strongly inhibit and/or induce metabolizing enzymes (CYP1A2, 2A6, 2c8, 2c19, 3A4 and 3A5) are contraindicated for use with HNC364, strong inhibitors of liver metabolizing enzymes
- Within 4 weeks prior to study drug administration until 30 days post dose, dextromethorphan is contraindicated for use with HNC364.
- Within 2 weeks prior to study drug administration until 44 days post dose, Meperidine, tramadol, methadone, propoxyphene, and MAO inhibitors (MAOIs), including other selective MAO-B inhibitors are contraindicated for use with HNC364.
Who cannot join
None listed.
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: Phase 1, Non-randomized, Single Ascending Doses (SAD) Study Following Single Injection in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HNC364 Injectable Suspension
This is a non-randomized, dose-escalation first-in-human study to evaluate the safety, tolerability, PK, and PD of HNC364 following intramuscular administration of single ascending doses.
- Conditions
- Parkinson's Disease
- Being tested
- HNC364
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HNC364Drug
Also called HNC364 injectable suspension
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.
HNC364Drug
Also called HNC364 injectable suspension
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.
HNC364Drug
Also called HNC364 injectable suspension
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.
HNC364Drug
Also called HNC364 injectable suspension
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.
| Study group | Role | What they receive |
|---|---|---|
| 20 mg HNC364 | Experimental | pre-study will recruit 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 will be admitted to the clinical study center on Day -1 and receive a single intramuscular dose of 20 mg HNC364 on Day 1, and undergo timed safety, PK, and PD assessments for 80 days post dose. Receives: Drug: HNC364 |
| 40 mg HNC364 | Experimental | 8 subjects will be admitted to the clinical study center on Day -1 and receive a single intramuscular dose of 40 mg HNC364 on Day 1, and undergo timed safety, PK, and PD assessments for 29 days post dose. Receives: Drug: HNC364 |
| 60 mg HNC364 | Experimental | 8 subjects will be admitted to the clinical study center on Day -1 and receive a single intramuscular dose of 60 mg HNC364 on Day 1, and undergo timed safety, PK, and PD assessments for 60 days post dose. Receives: Drug: HNC364 |
| 80 mg HNC364 | Experimental | 8 subjects will be admitted to the clinical study center on Day -1 and receive a single intramuscular dose of 80 mg HNC364 on Day 1, and undergo timed safety, PK, and PD assessments for 60days post dose. Receives: Drug: HNC364 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Emergent Adverse Events
This safety outcome lists the number of subjects experiencing adverse events (AEs), whether not related, possibly or unlikely related to the study treatment.
Measured: Day 1 to 80 days post dose
Secondary outcomes (10)
Maximum observed concentration (Cmax)
PK blood samples will be collected at the following timepoints: pre dose (within 60 min); post dose at 1, 4, 8, 12 (±5 min), 24, 48, 72, 96, 120 and 144 h (±60 min); Days 9, 11, 13, 15, 17, 20, 23, 26, 29, 34, 39, 46, 53, 60, 70 and 80.
Measured: Day 1 to 80 days post dose
Time to maximum concentration (Tmax)
PK blood samples will be collected at the following timepoints: pre dose (within 60 min); post dose at 1, 4, 8, 12 (±5 min), 24, 48, 72, 96, 120 and 144 h (±60 min); Days 9, 11, 13, 15, 17, 20, 23, 26, 29, 34, 39, 46, 53, 60, 70 and 80.
Measured: Day 1 to 80 days post dose
Time at which half the drug has been eliminated (t½)
PK blood samples will be collected at the following timepoints: pre dose (within 60 min); post dose at 1, 4, 8, 12 (±5 min), 24, 48, 72, 96, 120 and 144 h (±60 min); Days 9, 11, 13, 15, 17, 20, 23, 26, 29, 34, 39, 46, 53, 60, 70 and 80.
Measured: Day 1 to 80 days post dose
Area under the concentration-time curve (AUC) from time 0 to the last measurable concentration (AUC0-last)
PK blood samples will be collected at the following timepoints: pre dose (within 60 min); post dose at 1, 4, 8, 12 (±5 min), 24, 48, 72, 96, 120 and 144 h (±60 min); Days 9, 11, 13, 15, 17, 20, 23, 26, 29, 34, 39, 46, 53, 60, 70 and 80.
Measured: Day 1 to 80 days post dose
AUC extrapolated to infinity (AUC0-inf)
PK blood samples will be collected at the following timepoints: pre dose (within 60 min); post dose at 1, 4, 8, 12 (±5 min), 24, 48, 72, 96, 120 and 144 h (±60 min); Days 9, 11, 13, 15, 17, 20, 23, 26, 29, 34, 39, 46, 53, 60, 70 and 80.
Measured: Day 1 to 80 days post dose
Mean residence time (MRT)
PK blood samples will be collected at the following timepoints: pre dose (within 60 min); post dose at 1, 4, 8, 12 (±5 min), 24, 48, 72, 96, 120 and 144 h (±60 min); Days 9, 11, 13, 15, 17, 20, 23, 26, 29, 34, 39, 46, 53, 60, 70 and 80.
Measured: Day 1 to 80 days post dose
Apparent total clearance for extravascular administration (CL/F)
PK blood samples will be collected at the following timepoints: pre dose (within 60 min); post dose at 1, 4, 8, 12 (±5 min), 24, 48, 72, 96, 120 and 144 h (±60 min); Days 9, 11, 13, 15, 17, 20, 23, 26, 29, 34, 39, 46, 53, 60, 70 and 80.
Measured: Day 1 to 80 days post dose
Apparent volume of distribution during terminal phase (Vz/F)
PK blood samples will be collected at the following timepoints: pre dose (within 60 min); post dose at 1, 4, 8, 12 (±5 min), 24, 48, 72, 96, 120 and 144 h (±60 min); Days 9, 11, 13, 15, 17, 20, 23, 26, 29, 34, 39, 46, 53, 60, 70 and 80.
Measured: Day 1 to 80 days post dose
Elimination rate constant (Kel)
PK blood samples will be collected at the following timepoints: pre dose (within 60 min); post dose at 1, 4, 8, 12 (±5 min), 24, 48, 72, 96, 120 and 144 h (±60 min); Days 9, 11, 13, 15, 17, 20, 23, 26, 29, 34, 39, 46, 53, 60, 70 and 80.
Measured: Day 1 to 80 days post dose
Platelet MAO-B activity
Blood samples for PD analysis will be collected at the same following timepoints: pre dose (within 60 min); post dose at 4, 12 (±5 min), 24, 48, 72, 96, 120 and 144 h (±60 min); Days 9, 11, 13, 15, 17, 20, 23, 26, 29, 34, 39, 46, 53, 60, 70 and 80.
Measured: Day 1 to 80 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 posted31 Aug 2022
- Study start22 Aug 2022
- Primary completion15 Apr 2024
- Study completion15 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou Henovcom Bioscience Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frank Lee, MD, Principal investigator, Frontage Clinical Services, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05523570
- Sponsor's protocol ID
- HNC364-A101
- Status last verified
- Sep 2024
- First submitted
- 24 Aug 2022
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Non-randomized, Single Ascending Doses (SAD) Study Following Single Injection in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HNC364 Injectable Suspension
- ClinicalTrials.gov ID
- NCT05523570
- Acronym / sponsor ID
- HNC364-A101
- Conditions
- Parkinson's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Guangzhou Henovcom Bioscience Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Aug 2022 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 31 Aug 2022 (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.
This is a non-randomized, dose-escalation first-in-human study to evaluate the safety, tolerability, PK, and PD of HNC364 following intramuscular administration of single ascending doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 20 mg HNC364 | Experimental | Drug: HNC364pre-study will recruit 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 will be admitted to the clinical study center on Day -1 and receive a single intramuscular dose of 20 mg HNC364 on Day 1, and undergo timed safety, PK, and PD assessments for 80 days post dose. |
| 40 mg HNC364 | Experimental | Drug: HNC3648 subjects will be admitted to the clinical study center on Day -1 and receive a single intramuscular dose of 40 mg HNC364 on Day 1, and undergo timed safety, PK, and PD assessments for 29 days post dose. |
| 60 mg HNC364 | Experimental | Drug: HNC3648 subjects will be admitted to the clinical study center on Day -1 and receive a single intramuscular dose of 60 mg HNC364 on Day 1, and undergo timed safety, PK, and PD assessments for 60 days post dose. |
| 80 mg HNC364 | Experimental | Drug: HNC3648 subjects will be admitted to the clinical study center on Day -1 and receive a single intramuscular dose of 80 mg HNC364 on Day 1, and undergo timed safety, PK, and PD assessments for 60days post dose. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (22 listed)
- 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 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.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| HNC364Also: HNC364 injectable suspension2 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 | 20 mg HNC364 |
| HNC364Also: HNC364 injectable suspension8 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 | 40 mg HNC364 |
| HNC364Also: HNC364 injectable suspension8 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 | 60 mg HNC364 |
| HNC364Also: HNC364 injectable suspension8 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. | Drug | 80 mg HNC364 |
Primary outcome
Number of Participants With Treatment Emergent Adverse Events
Time frame: Day 1 to 80 days post dose
This safety outcome lists the number of subjects experiencing adverse events (AEs), whether not related, possibly or unlikely related to the study treatment.
10 secondary outcomes
Maximum observed concentration (Cmax)
Time frame: Day 1 to 80 days post dose
Time to maximum concentration (Tmax)
Time frame: Day 1 to 80 days post dose
Time at which half the drug has been eliminated (t½)
Time frame: Day 1 to 80 days post dose
Area under the concentration-time curve (AUC) from time 0 to the last measurable concentration (AUC0-last)
Time frame: Day 1 to 80 days post dose
AUC extrapolated to infinity (AUC0-inf)
Time frame: Day 1 to 80 days post dose
Mean residence time (MRT)
Time frame: Day 1 to 80 days post dose
Apparent total clearance for extravascular administration (CL/F)
Time frame: Day 1 to 80 days post dose
Apparent volume of distribution during terminal phase (Vz/F)
Time frame: Day 1 to 80 days post dose
Elimination rate constant (Kel)
Time frame: Day 1 to 80 days post dose
Platelet MAO-B activity
Time frame: Day 1 to 80 days post dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- 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.
Frank Lee, MD principal investigator
Frontage Clinical Services, Inc.
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 in people with Parkinson's Disease, 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 22 inclusion and 0 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: finished, as of the sponsor's last update on 27 Sep 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Participants With Treatment Emergent Adverse Events (time frame: Day 1 to 80 days post dose). 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 27 Sep 2024.