QG101-23-0 Capsules SAD and MAD Study in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: QG101-23-0 capsules; Drug: Placebo

• Registration Number: NCT05650528
• Lead Sponsor: Amckaus PTY LTD.

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.

Study Timeline

• Study First Submitted: 2022-11-29
• Study First Submitted QC: 2022-12-06
• Study First Posted: 2022-12-14
• Study Start: 2023-03-21
• Primary Completion: 2024-01-24
• Study Completion: 2024-02-26
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-25
• Last Update Posted: 2024-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Part A	Placebo	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)
Part B	QG101-23-0 capsules	Three multiple-ascending dose levels (Cohort B1\\Cohort B2\\Cohort B3) of MAD QG101-23-0 capsules (n=6) or placebo (n=2)
Part B	Placebo	Three multiple-ascending dose levels (Cohort B1\\Cohort B2\\Cohort B3) of MAD QG101-23-0 capsules (n=6) or placebo (n=2)
Part C	QG101-23-0 capsules	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.
Part A	QG101-23-0 capsules	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)
Part C	Placebo	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.

Primary Outcome Measures

Name	Time	Method
The safety and tolerability of single-dose ascending of oral QG101-23-0 capsules in healthy subjects	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	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 Outcome Measures

Name	Time	Method
Time of observed minimum concentration at steady state (Tmin,ss)	Day1-15 (MAD)	Pharmacokinetics
Observed maximum concentration at steady state (Cmax,ss)	Day1-15 (MAD)	Pharmacokinetics
Time of Cmax at steady state (Tmax,ss)	Day1-15 (MAD)	Pharmacokinetics
Apparent distribution volume corrected for bioavailability（Vd/F）	Day1-8 (SAD)	Pharmacokinetics
Apparent volume of distribution at steady-state (Vss)	Day1-8 (SAD)	Pharmacokinetics
Apparent terminal elimination rate constant (λz)	Day1-8 (SAD)	Pharmacokinetics
Mean residence time (MRT)	Day1-15 (MAD)	Pharmacokinetics
Apparent total clearance (CL)	Day1-8 (SAD)	Pharmacokinetics
AUC from time 0 to 12 hours（AUC0-12）	Day1-8 (SAD)	Pharmacokinetics
AUC from time 0 to 24 hours（AUC0-24）	Day1-8 (SAD)	Pharmacokinetics
AUC extrapolated from time 0 to infinity（AUC0-∞）	Day1-8 (SAD)	Pharmacokinetics
Apparent terminal elimination half-life （t1/2）	Day1-8 (SAD)	Pharmacokinetics
Observed minimum concentration at steady state (Cmin,ss)	Day1-15 (MAD)	Pharmacokinetics
Average Concentration at steady state (Cav,ss)	Day1-15 (MAD)	Pharmacokinetics
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)	Pharmacokinetics
After steady state, the area under the blood concentration - time curve from 0 point of one administration to infinity （AUC0-∞，ss）	Day1-15 (MAD)	Pharmacokinetics
Area under the concentration-time curve from time 0 to the end of the dosing interval (AUC0-tau)	Day1-15 (MAD)	Pharmacokinetics
Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-inf)	Day1-15 (MAD)	Pharmacokinetics
Apparent terminal elimination half-life (t1/2)	Day1-15 (MAD)	Pharmacokinetics
CL for bioavailability at steady state (CL/F, ss)	Day1-15 (MAD)	Pharmacokinetics
Vd/F at steady state (Vd/F, ss)	Day1-15 (MAD)	Pharmacokinetics
Accumulation ratio (AR)	Day1-15 (MAD)	Pharmacokinetics
Accumulation ratios for AUC	Day1-15 (MAD)	Pharmacokinetics
Accumulation ratios for Cmax	Day1-15 (MAD)	Pharmacokinetics
Maximum observed concentration（Cmax）	Day1-8 (SAD)	Pharmacokinetics
Time of Cmax（Tmax）	Day1-8 (SAD)	Pharmacokinetics
Area under the concentration-time curve (AUC) from time 0 to the time of the last quantifiable concentration（AUC0-t）	Day1-8 (SAD)	Pharmacokinetics

Trial Locations

Locations (1)

CMAX Clinical Research Pty Ltd; 🇦🇺 Adelaide, Australia