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
Overview
- Phase
- Phase 1
- Intervention
- HNC364
- Conditions
- Parkinson's Disease
- Sponsor
- Guangzhou Henovcom Bioscience Co. Ltd.
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Number of Participants With Treatment Emergent Adverse Events
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects who meet any of the following criteria must be excluded from the study:
- •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 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.
- •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.
Exclusion Criteria
- Not provided
Arms & Interventions
20 mg HNC364
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.
Intervention: HNC364
40 mg HNC364
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.
Intervention: HNC364
60 mg HNC364
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.
Intervention: HNC364
80 mg HNC364
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.
Intervention: HNC364
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Maximum observed concentration (Cmax)(Day 1 to 80 days post dose)
- Time at which half the drug has been eliminated (t½)(Day 1 to 80 days post dose)
- Platelet MAO-B activity(Day 1 to 80 days post dose)
- Time to maximum concentration (Tmax)(Day 1 to 80 days post dose)
- Area under the concentration-time curve (AUC) from time 0 to the last measurable concentration (AUC0-last)(Day 1 to 80 days post dose)
- AUC extrapolated to infinity (AUC0-inf)(Day 1 to 80 days post dose)
- Mean residence time (MRT)(Day 1 to 80 days post dose)
- Apparent total clearance for extravascular administration (CL/F)(Day 1 to 80 days post dose)
- Apparent volume of distribution during terminal phase (Vz/F)(Day 1 to 80 days post dose)
- Elimination rate constant (Kel)(Day 1 to 80 days post dose)