Healthy VolunteersPhase 1NCT05650528
QG101-23-0 Capsules SAD and MAD Study in Healthy Subjects
A Phase 1 study testing QG101-23-0 capsules in people with Healthy Volunteers, run by Amckaus PTY LTD. at 1 site in Australia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- QG101-23-0 capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteAustralia
- Study dates
- 21 Mar 2023to 26 Feb 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 28Show fewer
- 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.
- 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.
- Pregnant or lactating females or females of childbearing potential and males are unwilling to take effective contraceptive measures.
- 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.
- 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).
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Poor peripheral venous access.
- History of constipation or the inability to maintain regular bowel movements for the subjects of Cohort A3 within 3 months before administration.
- In addition to the above, subject who, in the opinion of the Investigator (or designee), should not participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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).
Read the 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.
- Conditions
- Healthy Volunteers
- Being tested
- QG101-23-0 capsules, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QG101-23-0 capsulesDrug
Single and Multiple Dose for oral
PlaceboDrug
Single and Multiple Dose for oral
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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. Receives: Drug: QG101-23-0 capsules; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Day1-15 (MAD)
Secondary outcomes (28)
Maximum observed concentration（Cmax）
Pharmacokinetics
Measured: Day1-8 (SAD)
Time of Cmax（Tmax）
Pharmacokinetics
Measured: Day1-8 (SAD)
Area under the concentration-time curve (AUC) from time 0 to the time of the last quantifiable concentration（AUC0-t）
Pharmacokinetics
Measured: Day1-8 (SAD)
AUC from time 0 to 12 hours（AUC0-12）
Pharmacokinetics
Measured: Day1-8 (SAD)
AUC from time 0 to 24 hours（AUC0-24）
Pharmacokinetics
Measured: Day1-8 (SAD)
AUC extrapolated from time 0 to infinity（AUC0-∞）
Pharmacokinetics
Measured: Day1-8 (SAD)
Apparent terminal elimination half-life （t1/2）
Pharmacokinetics
Measured: Day1-8 (SAD)
Apparent distribution volume corrected for bioavailability（Vd/F）
Pharmacokinetics
Measured: Day1-8 (SAD)
Apparent volume of distribution at steady-state (Vss)
Pharmacokinetics
Measured: Day1-8 (SAD)
Apparent terminal elimination rate constant (λz)
Pharmacokinetics
Measured: Day1-8 (SAD)
Mean residence time (MRT)
Pharmacokinetics
Measured: Day1-8 (SAD)
Apparent total clearance (CL)
Pharmacokinetics
Measured: Day1-8 (SAD)
Observed maximum concentration at steady state (Cmax,ss)
Pharmacokinetics
Measured: Day1-15 (MAD)
Observed minimum concentration at steady state (Cmin,ss)
Pharmacokinetics
Measured: Day1-15 (MAD)
Time of Cmax at steady state (Tmax,ss)
Pharmacokinetics
Measured: Day1-15 (MAD)
Average Concentration at steady state (Cav,ss)
Pharmacokinetics
Measured: Day1-15 (MAD)
Time of observed minimum concentration at steady state (Tmin,ss)
Pharmacokinetics
Measured: 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)
Pharmacokinetics
Measured: Day1-15 (MAD)
After steady state, the area under the blood concentration - time curve from 0 point of one administration to infinity （AUC0-∞，ss）
Pharmacokinetics
Measured: Day1-15 (MAD)
Area under the concentration-time curve from time 0 to the end of the dosing interval (AUC0-tau)
Pharmacokinetics
Measured: Day1-15 (MAD)
Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-inf)
Pharmacokinetics
Measured: Day1-15 (MAD)
Apparent terminal elimination half-life (t1/2)
Pharmacokinetics
Measured: Day1-15 (MAD)
CL for bioavailability at steady state (CL/F, ss)
Pharmacokinetics
Measured: Day1-15 (MAD)
Vd/F at steady state (Vd/F, ss)
Pharmacokinetics
Measured: Day1-15 (MAD)
Mean residence time (MRT)
Pharmacokinetics
Measured: Day1-15 (MAD)
Accumulation ratio (AR)
Pharmacokinetics
Measured: Day1-15 (MAD)
Accumulation ratios for Cmax
Pharmacokinetics
Measured: Day1-15 (MAD)
Accumulation ratios for AUC
Pharmacokinetics
Measured: Day1-15 (MAD)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start21 Mar 2023
- Primary completion24 Jan 2024
- Study completion26 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amckaus PTY LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited
- Responsible party
- Sponsor
- Investigators
- Angela Rowland, Principal investigator, CMAX Clinical Research Pty Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05650528
- Sponsor's protocol ID
- Aom0315-ACT-01
- Status last verified
- Nov 2024
- First submitted
- 29 Nov 2022
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05650528
- Acronym / sponsor ID
- Aom0315-ACT-01
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Amckaus PTY LTD.Industry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited
- Study start
- 21 Mar 2023 (actual)
- Primary completion
- 24 Jan 2024 (actual)
- Study completion
- 26 Feb 2024 (actual)
- First posted
- 14 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part A | Experimental | Drug: QG101-23-0 capsules, Drug: PlaceboSix 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 | Experimental | Drug: QG101-23-0 capsules, Drug: PlaceboThree multiple-ascending dose levels (Cohort B1\Cohort B2\Cohort B3) of MAD QG101-23-0 capsules (n=6) or placebo (n=2) |
| Part C | Experimental | Drug: QG101-23-0 capsules, Drug: PlaceboCohort 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (28 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QG101-23-0 capsulesSingle and Multiple Dose for oral | Drug | Part A, Part B, Part C |
| PlaceboSingle and Multiple Dose for oral | Drug | Part A, Part B, Part C |
Primary outcome
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
28 secondary outcomes
Maximum observed concentration（Cmax）
Time frame: Day1-8 (SAD)
Time of Cmax（Tmax）
Time frame: Day1-8 (SAD)
Area under the concentration-time curve (AUC) from time 0 to the time of the last quantifiable concentration（AUC0-t）
Time frame: Day1-8 (SAD)
AUC from time 0 to 12 hours（AUC0-12）
Time frame: Day1-8 (SAD)
AUC from time 0 to 24 hours（AUC0-24）
Time frame: Day1-8 (SAD)
AUC extrapolated from time 0 to infinity（AUC0-∞）
Time frame: Day1-8 (SAD)
Apparent terminal elimination half-life （t1/2）
Time frame: Day1-8 (SAD)
Apparent distribution volume corrected for bioavailability（Vd/F）
Time frame: Day1-8 (SAD)
Apparent volume of distribution at steady-state (Vss)
Time frame: Day1-8 (SAD)
Apparent terminal elimination rate constant (λz)
Time frame: Day1-8 (SAD)
Mean residence time (MRT)
Time frame: Day1-8 (SAD)
Apparent total clearance (CL)
Time frame: Day1-8 (SAD)
Observed maximum concentration at steady state (Cmax,ss)
Time frame: Day1-15 (MAD)
Observed minimum concentration at steady state (Cmin,ss)
Time frame: Day1-15 (MAD)
Time of Cmax at steady state (Tmax,ss)
Time frame: Day1-15 (MAD)
Average Concentration at steady state (Cav,ss)
Time frame: Day1-15 (MAD)
Time of observed minimum concentration at steady state (Tmin,ss)
Time frame: 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)
Time frame: Day1-15 (MAD)
After steady state, the area under the blood concentration - time curve from 0 point of one administration to infinity （AUC0-∞，ss）
Time frame: Day1-15 (MAD)
Area under the concentration-time curve from time 0 to the end of the dosing interval (AUC0-tau)
Time frame: Day1-15 (MAD)
Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-inf)
Time frame: Day1-15 (MAD)
Apparent terminal elimination half-life (t1/2)
Time frame: Day1-15 (MAD)
CL for bioavailability at steady state (CL/F, ss)
Time frame: Day1-15 (MAD)
Vd/F at steady state (Vd/F, ss)
Time frame: Day1-15 (MAD)
Mean residence time (MRT)
Time frame: Day1-15 (MAD)
Accumulation ratio (AR)
Time frame: Day1-15 (MAD)
Accumulation ratios for Cmax
Time frame: Day1-15 (MAD)
Accumulation ratios for AUC
Time frame: Day1-15 (MAD)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angela Rowland principal investigator
CMAX Clinical Research Pty Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing QG101-23-0 capsules in people with Healthy Volunteers, run by Amckaus PTY LTD. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The safety and tolerability of single-dose ascending of oral QG101-23-0 capsules in healthy subjects (time frame: Day1-8 (SAD)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.