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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05650528




Registration number
NCT05650528
Ethics application status
Date submitted
29/11/2022
Date registered
14/12/2022

Titles & IDs
Public title
QG101-23-0 Capsules SAD and MAD Study in Healthy Subjects
Scientific title
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
Secondary ID [1] 0 0
Aom0315-ACT-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - QG101-23-0 capsules
Treatment: Drugs - Placebo

Experimental: 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)

Experimental: 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)

Experimental: 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.


Treatment: Drugs: QG101-23-0 capsules
Single and Multiple Dose for oral

Treatment: Drugs: Placebo
Single and Multiple Dose for oral
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The safety and tolerability of single-dose ascending of oral QG101-23-0 capsules in healthy subjects
Timepoint [1] 0 0
Day1-8 (SAD)
Primary outcome [2] 0 0
The safety and tolerability of multiple-dose ascending oral QG101-23-0 capsules in healthy subjects
Timepoint [2] 0 0
Day1-15 (MAD)
Secondary outcome [1] 0 0
Maximum observed concentration(Cmax)
Timepoint [1] 0 0
Day1-8 (SAD)
Secondary outcome [2] 0 0
Time of Cmax(Tmax)
Timepoint [2] 0 0
Day1-8 (SAD)
Secondary outcome [3] 0 0
Area under the concentration-time curve (AUC) from time 0 to the time of the last quantifiable concentration(AUC0-t)
Timepoint [3] 0 0
Day1-8 (SAD)
Secondary outcome [4] 0 0
AUC from time 0 to 12 hours(AUC0-12)
Timepoint [4] 0 0
Day1-8 (SAD)
Secondary outcome [5] 0 0
AUC from time 0 to 24 hours(AUC0-24)
Timepoint [5] 0 0
Day1-8 (SAD)
Secondary outcome [6] 0 0
AUC extrapolated from time 0 to infinity(AUC0-8)
Timepoint [6] 0 0
Day1-8 (SAD)
Secondary outcome [7] 0 0
Apparent terminal elimination half-life (t1/2)
Timepoint [7] 0 0
Day1-8 (SAD)
Secondary outcome [8] 0 0
Apparent distribution volume corrected for bioavailability(Vd/F)
Timepoint [8] 0 0
Day1-8 (SAD)
Secondary outcome [9] 0 0
Apparent volume of distribution at steady-state (Vss)
Timepoint [9] 0 0
Day1-8 (SAD)
Secondary outcome [10] 0 0
Apparent terminal elimination rate constant (?z)
Timepoint [10] 0 0
Day1-8 (SAD)
Secondary outcome [11] 0 0
Mean residence time (MRT)
Timepoint [11] 0 0
Day1-8 (SAD)
Secondary outcome [12] 0 0
Apparent total clearance (CL)
Timepoint [12] 0 0
Day1-8 (SAD)
Secondary outcome [13] 0 0
Observed maximum concentration at steady state (Cmax,ss)
Timepoint [13] 0 0
Day1-15 (MAD)
Secondary outcome [14] 0 0
Observed minimum concentration at steady state (Cmin,ss)
Timepoint [14] 0 0
Day1-15 (MAD)
Secondary outcome [15] 0 0
Time of Cmax at steady state (Tmax,ss)
Timepoint [15] 0 0
Day1-15 (MAD)
Secondary outcome [16] 0 0
Average Concentration at steady state (Cav,ss)
Timepoint [16] 0 0
Day1-15 (MAD)
Secondary outcome [17] 0 0
Time of observed minimum concentration at steady state (Tmin,ss)
Timepoint [17] 0 0
Day1-15 (MAD)
Secondary outcome [18] 0 0
After steady state, the interval from 0 point of one administration to administration t Area under the plasma concentration - time curve (AUC0-t,ss)
Timepoint [18] 0 0
Day1-15 (MAD)
Secondary outcome [19] 0 0
After steady state, the area under the blood concentration - time curve from 0 point of one administration to infinity (AUC0-8,ss)
Timepoint [19] 0 0
Day1-15 (MAD)
Secondary outcome [20] 0 0
Area under the concentration-time curve from time 0 to the end of the dosing interval (AUC0-tau)
Timepoint [20] 0 0
Day1-15 (MAD)
Secondary outcome [21] 0 0
Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-inf)
Timepoint [21] 0 0
Day1-15 (MAD)
Secondary outcome [22] 0 0
Apparent terminal elimination half-life (t1/2)
Timepoint [22] 0 0
Day1-15 (MAD)
Secondary outcome [23] 0 0
CL for bioavailability at steady state (CL/F, ss)
Timepoint [23] 0 0
Day1-15 (MAD)
Secondary outcome [24] 0 0
Vd/F at steady state (Vd/F, ss)
Timepoint [24] 0 0
Day1-15 (MAD)
Secondary outcome [25] 0 0
Mean residence time (MRT)
Timepoint [25] 0 0
Day1-15 (MAD)
Secondary outcome [26] 0 0
Accumulation ratio (AR)
Timepoint [26] 0 0
Day1-15 (MAD)
Secondary outcome [27] 0 0
Accumulation ratios for Cmax
Timepoint [27] 0 0
Day1-15 (MAD)
Secondary outcome [28] 0 0
Accumulation ratios for AUC
Timepoint [28] 0 0
Day1-15 (MAD)

Eligibility
Key inclusion criteria
Subjects must satisfy all the following criteria at the Screening visit and Check-in unless otherwise stated:

1. Males or females, between 18 and 55 years of age, inclusive.
2. 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).
3. 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.
4. 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.
5. 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.
6. 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.
7. Able to comprehend and willing to sign an informed consent form (ICF) and to abide by the study restrictions.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
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:

1. 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).
2. 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);
3. 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;
4. 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.
5. 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;
6. 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).
7. 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.
8. Any of the following on the ECG at Screening and Check-in (Day -1).

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.
2. QRS duration > 120 msec, confirmed by repeat measurement at least two times.
3. PR interval > 220 msec, confirmed by repeat measurement at least two times.
4. Findings which would make QTc measurements difficult or QTc data uninterpretable.
5. History of additional risk factors for torsades de pointes (e.g., heart failure, hypokalaemia, family history of long QT syndrome).
6. Abnormal QRS or ST segment indicates a clinically significant abnormality of myocardia, e.g., cardiomyopathy, cardiac ischaemia or myocardial infarction, etc.
9. History of stomach or intestinal surgery or resection, vagotomy, or any surgery (uncomplicated appendectomy and hernia repair will be allowed, but not cholecystectomy) or adverse syndromes (such as Crohn's disease, Irritable Bowel Syndrome , chronic pancreatitis or congenital nonhaemolytic hyperbilirubinemia [e.g., suspicion of Gilbert's syndrome based on total and direct bilirubin, the subjects with total or direct or indirect bilirubin > 35%× the upper limit of normal at Screening or Check-in]) that would potentially alter gastrointestinal peristalsis, pH, absorption and/or excretion of orally administered drugs.
10. Pregnant or lactating females or females of childbearing potential and males are unwilling to take effective contraceptive measures.
11. Having foods and beverages containing poppy seeds, grapefruit and orange including Seville oranges or wine containing extracts from the above fruits within 3 days prior to Check-in until the follow-up visit.
12. Use or intend to use any medications / products including any prescription or over-the-counter drugs known to alter drug absorption, metabolism, or elimination processes, including vitamin therapy, minerals, and phytotherapeutic / traditional Chinese medicine such as St. John's wort /plant-derived preparations, within 30 days prior to the first dose of study medication until completion of the follow-up visit, unless deemed acceptable by the Investigator (or designee).
13. Having lost blood or donated blood 500 mL or more, within 56 days prior to Screening. Receipt of blood products within 60 days prior to Check-in. The Participants who plan to donate blood from the Screening to 56 days after the follow-up visit.
14. Participation in a clinical study involving administration of an investigational drug or having received any vaccines (including any new investigational vaccines and any approved vaccines such as influenza or COVID-19 vaccines) or a biological product within 30 days (or within five half-lives of the test drug) prior to dosing.
15. History of drug/chemical abuse or substance abuse; Regular consumption of the amount of alcohol (in an Australian standard drink) of more than two standard drinks per day or 14 standard drinks per week within 6 months prior to your admission to the clinical unit (One standard drink is equivalent to 10 grams of alcohol: approximately 285 mL full-strength beer or cider [4.9%], 375 mL mid-strength beer [3.5%], 425 mL light- strength beer [2.7%], 100 mL wine or 30 mL shot of 40% spirit). A positive alcohol breath test at Screening or Day -1, or inability to abstain from alcohol during the study (Within 3 days prior to Check-in until the follow-up visit); Urine drugs of abuse testing as detailed in Appendix 4.
16. Positive alcohol breath test result or positive urine drug screen at Screening or Check-in. Urine drugs of abuse testing as detailed in Appendix 4.
17. History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection at Check-in.
18. Smoke more than five cigarettes per day within 30 days prior to dosing (Day 1) or inability to abstain from tobacco- or nicotine-containing products during the study (Within 3 days prior to Check-in until the check-out) or positive at Screening or Check-in for any other reason.
19. Poor peripheral venous access.
20. History of constipation or the inability to maintain regular bowel movements for the subjects of Cohort A3 within 3 months before administration.
21. In addition to the above, subject who, in the opinion of the Investigator (or designee), should not participate in this study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/02/2024
Sample size
Target
Accrual to date
Final
78
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
CMAX Clinical Research Pty Ltd - Adelaide
Recruitment postcode(s) [1] 0 0
- Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Amckaus PTY LTD.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Novotech (Australia) Pty Limited
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Angela Rowland
Address 0 0
CMAX Clinical Research Pty Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Huaqin Shi
Address 0 0
Country 0 0
Phone 0 0
+86-571-86504023
Fax 0 0
Email 0 0
shihuaqin@adamerck.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05650528