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

NCT05650528 | Completed Phase 1

• 1 other identifier: Aom0315-ACT-01
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• The safety and tolerability of single-dose ascending of oral QG101-23-0 capsules in healthy subjects

  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

  Day1-8 (SAD)

• The safety and tolerability of multiple-dose ascending oral QG101-23-0 capsules in healthy subjects

  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

  Day1-15 (MAD)

Secondary Outcomes (28)

• 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)

• AUC from time 0 to 12 hours（AUC0-12）

  Day1-8 (SAD)

• AUC from time 0 to 24 hours（AUC0-24）

  Day1-8 (SAD)

Study Arms (3)

Part A

EXPERIMENTAL

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)

Drug: QG101-23-0 capsules; Drug: Placebo

Part B

EXPERIMENTAL

Three multiple-ascending dose levels (Cohort B1\\Cohort B2\\Cohort B3) of MAD QG101-23-0 capsules (n=6) or placebo (n=2)

Drug: QG101-23-0 capsules; Drug: Placebo

Part C

EXPERIMENTAL

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.

Drug: QG101-23-0 capsules; Drug: Placebo

Interventions

QG101-23-0 capsules DRUG

Single and Multiple Dose for oral

Part A; Part B; Part C

Placebo DRUG

Single and Multiple Dose for oral

Part A; Part B; Part C

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects must satisfy all the following criteria at the Screening visit and Check-in unless otherwise stated:
• Males or females, between 18 and 55 years of age, inclusive.
• Body weight is ≥ 50.0 kg for male subjects and ≥ 45.0 kg for female subjects, with a body mass index (BMI) of 18-32 kg / m2 (inclusive).
• In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), vital signs measurements, and clinical laboratory evaluations at Screening and Check-in as assessed by the Investigator (or designee), as applicable. Resting heart rate ≥ 45 bpm and ≤ 100 bpm at Screening.
• Male subjects must agree to refrain from sperm donation from the time of signing the informed consent form until 90 days after the last dosing and females should refrain from ova donation from the time of signing the informed consent form until 30 days after the last dosing. As detailed in Appendix 2.
• Females will not be pregnant or lactating, female subjects with a negative blood pregnancy test during the Screening period and a negative urine pregnancy test at Check-in, and male and female of childbearing potential having taken effective contraceptive measures at least from the date of signing the informed consent form and should agree to continue to use effective contraceptive measures from the date of signing the informed consent form until 90 days after the last dosing for males and 30 days after the last dosing for females. Males with vasectomy at least 90 days prior to the Screening visit must have documentation confirming Azoospermia or use other contraceptives. As detailed in Appendix 2.
• Females of nonchildbearing potential defined as permanently sterile (i.e., due to hysterectomy, bilateral salpingectomy, and/or bilateral oophorectomy; at least 3 months between sterlization date and screening date) or postmenopausal (defined as at least 12 months post cessation of menses without an alternative medical cause and follicle-stimulating hormone \[FSH\] level ≥ 30 IU/L). As detailed in Appendix 2.
• Able to comprehend and willing to sign an informed consent form (ICF) and to abide by the study restrictions.

You may not qualify if:

• Subjects will be excluded from the study if they satisfy any of the following criteria at the Screening visit and Check-in unless otherwise stated:
• Significant history or clinical manifestation of any metabolic, dermatological, hepatic, renal, haematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, acute or chronic infectious diseases and malignancies, as determined by the Investigator (or designee).
• History of hereditary bleeding disorders, coagulation disorders, non-traumatic bleeding requiring treatment, or thromboembolism; or currently have any disease that can cause bleeding (including coagulation disorder, thrombocytopenia \[platelet count \< 150×109/L\] and prothrombin time-international normalised ratio \> 1.5);
• Acute and chronic liver disease or serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 1.5 × the upper limit of normal at Screening or Check-in;
• History of acute and chronic kidney disease including acute and chronic renal insufficiency. Or impaired renal function defined by creatinine clearance (calculated using the Cockcroft-Gault equation) \< 90 mL/min at Screening or Check-in; See Appendix 3 Formulas Used in the Study.
• Abnormal blood pressure (defined as systolic blood pressure \> 145 mmHg or \< 90 mmHg, diastolic blood pressure \> 90 mmHg or \< 50 mmHg) at Screening or Check-in;
• History of clinically significant hypersensitivity, any intolerance, or any anaphylaxis to any drug compound including any components of the study drug capsules, such as lactose, hydroxypropyl methylcellulose, magnesium stearate, food, or other substance, unless approved by the Investigator (or designee).
• Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), and/or positive human immunodeficiency virus (HIV) test at Screening. Participants with previously treated HCV and hence HCV Ab positive may be included if a subsequent HCV RNA test is negative.
• Any of the following on the ECG at Screening and Check-in (Day -1).
• ECG is abnormal and clinically significant, or the corrected QTc interval (QTc is calculated by Fridericia correction formula: QTc = QT/ \[RR \^ 0.33\]) \> 450 msec (male) or \> 470 msec (female) is confirmed by repeat measurement at least two times. See Appendix 3 Formulas Used in the Study.
• QRS duration \> 120 msec, confirmed by repeat measurement at least two times.
• PR interval \> 220 msec, confirmed by repeat measurement at least two times.
• Findings which would make QTc measurements difficult or QTc data uninterpretable.
• History of additional risk factors for torsades de pointes (e.g., heart failure, hypokalaemia, family history of long QT syndrome).
• Abnormal QRS or ST segment indicates a clinically significant abnormality of myocardia, e.g., cardiomyopathy, cardiac ischaemia or myocardial infarction, etc.

Sponsors & Collaborators

• Amckaus PTY LTD.: lead
• Novotech (Australia) Pty Limited: collaborator

Study Sites (1)

CMAX Clinical Research Pty Ltd

Adelaide, Australia

Location

Study Officials

• Angela Rowland

  CMAX Clinical Research Pty Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2022
• First Posted: December 14, 2022
• Study Start: March 21, 2023
• Primary Completion: January 24, 2024
• Study Completion: February 26, 2024
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)