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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
34
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.
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.
Frontage Clinical Services, Inc.
Secaucus, New Jersey, United States
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.
Time frame: Day 1 to 80 days post dose
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.
Time frame: 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.
Time frame: 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.
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)
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.
Time frame: Day 1 to 80 days post dose
AUC extrapolated to infinity (AUC0-inf)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 1 to 80 days post dose