Single-center, Randomised, Double-blind, Placebo-controlled Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile of Single- and Multiple-dose Ascending Oral QG101-23-0 Capsules in Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- QG101-23-0 capsules
- Conditions
- Healthy Volunteers
- Sponsor
- Amckaus PTY LTD.
- Enrollment
- 78
- Locations
- 1
- Primary Endpoint
- The safety and tolerability of single-dose ascending of oral QG101-23-0 capsules in healthy subjects
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The study will consist of three parts: a single-dose ascending (SAD) phase (Part A) enrolling a total of five ~ six cohorts of healthy participants, a multiple-dose ascending (MAD) phase (Part B) enrolling 3 cohorts of healthy participants, and a food effect study (Part C).
Detailed Description
This study is a single-center, randomized, double-blind and placebo-controlled trial. Healthy subjects will receive single- and multiple-dose administration through oral of different doses of QG101-23-0 capsules to evaluate its safety, tolerability and pharmacokinetics profile.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Part A
Six single-ascending dose levels (Cohort A1\\Cohort A2\\Cohort A3\\Cohort A4\\Cohort A5\\Cohort A6) of SAD QG101-23-0 capsules (n=6) or placebo (n=2)
Intervention: QG101-23-0 capsules
Part A
Six single-ascending dose levels (Cohort A1\\Cohort A2\\Cohort A3\\Cohort A4\\Cohort A5\\Cohort A6) of SAD QG101-23-0 capsules (n=6) or placebo (n=2)
Intervention: Placebo
Part B
Three multiple-ascending dose levels (Cohort B1\\Cohort B2\\Cohort B3) of MAD QG101-23-0 capsules (n=6) or placebo (n=2)
Intervention: QG101-23-0 capsules
Part B
Three multiple-ascending dose levels (Cohort B1\\Cohort B2\\Cohort B3) of MAD QG101-23-0 capsules (n=6) or placebo (n=2)
Intervention: Placebo
Part C
Cohort A3 Group 1 (n=8) and Group 2 (n=6, additional recruitment) participated in the food effect study. The subjects took QG101-23-0 capsules while under fasting or fed condition.
Intervention: QG101-23-0 capsules
Part C
Cohort A3 Group 1 (n=8) and Group 2 (n=6, additional recruitment) participated in the food effect study. The subjects took QG101-23-0 capsules while under fasting or fed condition.
Intervention: Placebo
Outcomes
Primary Outcomes
The safety and tolerability of single-dose ascending of oral QG101-23-0 capsules in healthy subjects
Time Frame: Day1-8 (SAD)
Safety will be assessed by the number, severity and type of adverse events, including changes in clinical laboratory evaluations (e.g., Hematology, urinalysis, blood biochemistry, coagulation), vital signs (blood pressure, pulse rate, tympanic thermometers temperature and respiratory rate), ECGs (e.g., QTc interval, QRS duration, PR interval) and physical examinations
The safety and tolerability of multiple-dose ascending oral QG101-23-0 capsules in healthy subjects
Time Frame: Day1-15 (MAD)
Safety will be assessed by the number, severity and type of adverse events, including changes in clinical laboratory evaluations (e.g., Hematology, urinalysis, blood biochemistry, coagulation), vital signs (blood pressure, pulse rate, tympanic thermometers temperature and respiratory rate), ECGs (e.g., QTc interval, QRS duration, PR interval) and physical examinations
Secondary Outcomes
- Apparent distribution volume corrected for bioavailability（Vd/F）(Day1-8 (SAD))
- Apparent volume of distribution at steady-state (Vss)(Day1-8 (SAD))
- Apparent terminal elimination rate constant (λz)(Day1-8 (SAD))
- Mean residence time (MRT)(Day1-15 (MAD))
- Apparent total clearance (CL)(Day1-8 (SAD))
- Observed maximum concentration at steady state (Cmax,ss)(Day1-15 (MAD))
- Time of Cmax at steady state (Tmax,ss)(Day1-15 (MAD))
- Time of observed minimum concentration at steady state (Tmin,ss)(Day1-15 (MAD))
- AUC from time 0 to 12 hours（AUC0-12）(Day1-8 (SAD))
- AUC from time 0 to 24 hours（AUC0-24）(Day1-8 (SAD))
- AUC extrapolated from time 0 to infinity（AUC0-∞）(Day1-8 (SAD))
- Apparent terminal elimination half-life （t1/2）(Day1-8 (SAD))
- Observed minimum concentration at steady state (Cmin,ss)(Day1-15 (MAD))
- Average Concentration at steady state (Cav,ss)(Day1-15 (MAD))
- After steady state, the interval from 0 point of one administration to administration τ Area under the plasma concentration - time curve (AUC0-τ，ss)(Day1-15 (MAD))
- After steady state, the area under the blood concentration - time curve from 0 point of one administration to infinity （AUC0-∞，ss）(Day1-15 (MAD))
- Area under the concentration-time curve from time 0 to the end of the dosing interval (AUC0-tau)(Day1-15 (MAD))
- Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-inf)(Day1-15 (MAD))
- Apparent terminal elimination half-life (t1/2)(Day1-15 (MAD))
- CL for bioavailability at steady state (CL/F, ss)(Day1-15 (MAD))
- Vd/F at steady state (Vd/F, ss)(Day1-15 (MAD))
- Accumulation ratio (AR)(Day1-15 (MAD))
- Accumulation ratios for AUC(Day1-15 (MAD))
- Accumulation ratios for Cmax(Day1-15 (MAD))
- Maximum observed concentration（Cmax）(Day1-8 (SAD))
- Time of Cmax（Tmax）(Day1-8 (SAD))
- Area under the concentration-time curve (AUC) from time 0 to the time of the last quantifiable concentration（AUC0-t）(Day1-8 (SAD))