Healthy Adult SubjectsPhase 1NCT07752472
PSTC100 Study in Healthy Adult Subjects
A Phase 1 study testing PSTC100 tablets in people with Healthy Adult Subjects, run by Prospect Therapeutics (Nanjing) Limited at 1 site in Australia.
Trial summary
This study is a single-center, randomized, double-blind, placebo-controlled, dose-escalation phase I clinical trial designed to evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic (PD) characteristics of PSTC100 in healthy adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Subjects
- What is being tested?
- PSTC100 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Sep 2026to 10 Oct 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- 1.Fully understand the purpose and process of this study, voluntarily participate, and sign an informed consent form;
- 2.At the time of screening, applicants must be between 18 and 55 years old (inclusive), and there are no gender restrictions.
- 3.Body mass index (BMI) is between 18.0 and 32.0 kg/m² (inclusive).
- 4.Male participants should weigh no less than 50 kg, and female participants should weigh no less than 45 kg.
- 5.Based on the medical history, vital signs, physical examination, 12-lead electrocardiogram, laboratory tests (hematology, blood biochemistry, coagulation function, urinalysis), and other examination results, the subjects were in good health and no clinically significant abnormalities were found.
- 6.Female subject has no plans to conceive from the start of the screening period until 40 days after the last dose, and agrees to use contraceptive methods as detailed further in the protocol (see Appendix 11.2) from the time of signing the informed consent form until 40 days after the last dose. Male subject agrees to use contraceptive methods as detailed further in the protocol (see Appendix 11.2) with partners of childbearing potential from the time of signing the informed consent form until 100 days after the last dose.
- 7.Male subjects must agree to refrain from sperm donation from the time of signing the informed consent form until 100 days after the last dose and female subjects must refrain from ova donation from the time of signing the informed consent form until 40 days after the last dose.
Who cannot join
- 1.Pregnant women (or those with a positive pregnancy test), or breastfeeding women;
- 2.During the screening and baseline period, the pulse rate ≤ 45 beats/minute or > 100 beats/minute;
- 3.During the screening and baseline period, systolic blood pressure <90 mmHg or ≥140 mmHg, or diastolic blood pressure <50 mmHg or ≥90 mmHg;
- 4.Those who have special dietary requirements and cannot accept the standardized meals provided by the research center;
- 5.Drinking alcohol or consuming beverages rich in fructose (including but not limited to carbonated soft drinks, 100% fruit/pure juice etc.) or energy drinks during the screening and baseline period may affect blood glucose, lipid profile, or muscle metabolism.
- 6.During the screening and baseline period, drinking coffee, consuming St. John's wort, grapefruit, pomelo, cranberry, or engaging in strenuous exercise may affect drug absorption and metabolism.
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- 7.A history of eczema, no use of steroid creams for 3 months prior to screening; history fully resolved gestational diabetes; current or history of attention deficit hyperactivity disorder (ADHD), anxiety or depression (no use of antidepressants for at least 6 months prior to screening); Gilberts syndrome; or who have a history of or currently suffer from clinically confirmed cardiovascular, respiratory, digestive, endocrine, metabolic, neurological, dermatological, ophthalmic, infectious, or mental illnesses or abnormalities as per investigator's discretion;
- 8.Suspected or confirmed allergy to any component of the investigational drug, or a confirmed history of severe allergy;
- 9.Previous surgeries that may affect the results of clinical trials (such as cholecystectomy, partial gastrectomy, etc., but subjects with minor surgeries such as removal of superficial lipomas and appendectomy are acceptable).
- 10.Have taken any prescription medications within 14 days prior to screening, or over-the-counter drugs and herbal remedies (except for vitamins and calcium supplements) within 7 days prior to screening. However, use of paracetamol < 2 g per day for less than 7 days is allowed.
- 11.Those who have lost or donated more than 400 mL of blood within the 1 month prior to screening (excluding physiological blood loss);
- 12.Those who have participated in any clinical trials within the 3 months prior to screening (excluding those who failed the screening);
- 13.Those with a history of alcohol abuse: those who have consumed more than 14 standard alcohol units per week in the past 1 year (1 standard alcohol unit is approximately equivalent to 250 mL of 5% ABV beer; or 100 mL of 12.5% ABV wine; or 30 mL of 42% ABV spirits); or those who do not agree to abstain from alcohol during the trial period;
- 14.Those with a history of smoking: averaging ≥5 cigarettes per day in the 3 months prior to screening; or those who do not agree to abstain from smoking during the trial period;
- 15.Those with a history of drug abuse (if a participant engaged in use 3 years ago and is no longer a user, he/she is permitted to be included) or who tested positive for urine drugs abuse test during the screening and baseline period;
- 16.During the screening and baseline period, the breathalyzer test result was >0 mg/100mL;
- 17.During screening, subjects with clinically significant abnormalities in any of the following: Hepatitis B surface antigen, syphilis-specific antibodies, hepatitis C antibodies, or HIV antigen/antibody.
- 18.Any situation that researchers believe poses a safety risk to the subjects or may interfere with the conduct of this study, or any situation that researchers believe the subjects cannot comply with the relevant requirements of this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Nucleus Network Sydney Pty Ltd
Saint Leonards, New South Wales, 2065
Victor Wong, Doctor, 0737072709, v.wong@nucleusnetwork.com.au
Victor Wong, Doctor
About this study
Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PSTC100 in Healthy Adult Subjects
This study is a single-center, randomized, double-blind, placebo-controlled, dose-escalation phase I clinical trial designed to evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic (PD) characteristics of PSTC100 in healthy adult subjects.
Read the detailed description
This Phase I clinical trial is a randomized, double-blind, placebo-controlled, dose-escalation study consisting of two parts:
Part1: Single Ascending Dose (SAD) study Part2: Multiple Ascending Dose (MAD) study The SAD part employed a randomized, double-blind, placebo-controlled, dose-escalation design to evaluate the safety, tolerability, and PK/PD characteristics of a single dose of 25 mg to 400 mg PSTC100 tablets in healthy adults under fasting conditions.
Part 1 of the study comprises six dose cohorts (A1-A6) with doses of 25 mg, 50 mg, 100 mg, 200 mg, 300 mg, and 400 mg, respectively. Part 1 plans to enroll 46 subjects, with 6 subjects in cohort A1 (4 randomly assigned to the investigational drug and 2 to the placebo) and 8 subjects in each of the other cohorts (6 randomly assigned to the investigational drug and 2 to the placebo).
The MAD part employed a randomized, double-blind, placebo-controlled, and dose-escalation design to evaluate the safety, tolerability, and PK/PD characteristics of once-daily (QD) administration for 7 consecutive days within a dose range of 100 mg to 300 mg PSTC100 tablets in healthy adult subjects.
Part 2 of the study consists of three dose cohorts (A7-A9) with doses of 100 mg, 200 mg, and 300 mg, respectively. Part 2 plans to enroll 24 subjects, with 8 subjects in each cohort (6 randomly assigned to the investigational drug and 2 to the placebo).
- Conditions
- Healthy Adult Subjects
- Being tested
- PSTC100 tablets
- Keywords
- Phase 1, PSTC100, healthy adult subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSTC100 tabletsDrug
PSTC100 tablets
PSTC100 tabletsDrug
dose 7 once daily, dose 8 once daily, dose 9 once daily
| Study group | Role | What they receive |
|---|---|---|
| A SAD study includes 6 dose cohorts: Cohorts 1-6 | Experimental | This study employed a randomized, double-blind, placebo-controlled, dose-escalation design to evaluate the safety, tolerability, and PK/PD characteristics of a single dose of 25 mg to 400 mg PSTC100 tablets in healthy adults under fasting conditions. Receives: Drug: PSTC100 tablets |
| A MAD study with randomized, double-blind, placebo-controlled | Experimental | This study includes 3 dose cohorts (Cohorts 7-9): dose 7, dose 8, dose 9 once daily administration. All cohorts receive 7 consecutive days of dosing. This study plans to enroll 24 subjects, with 8 subjects in each cohort (6 randomly assigned to the investigational drug and 2 to the placebo) Receives: Drug: PSTC100 tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Peak Concentration (Tmax),
PK characteristics after single dose
Measured: Part 1 : Pre- dose to 24 hours , 48 hours post dose, 72 hours post dose Part 2 : Pre- dose to 12 hours, and 24 hours post Day 1 dose to be collected within 15 minutes pre Day 2 dose
Peak Concentration (Cmax),
PK characteristics after single dose
Measured: Pre- dose to 24 hours , 48 hours post dose, 72 hours post dose Part 2 : Pre- dose to 12 hours, and 24 hours post Day 1 dose to be collected within 15 minutes pre Day 2 dose
Area Under the Concentration - Time Curve (AUC0-24h, AUC0-t, AUC0-∞, etc.)
PK characteristics after single dose
Measured: Part 1 : Pre- dose to 24 hours , 48 hours post dose, 72 hours post dose Part 2 : Pre- dose to 12 hours, and 24 hours post Day 1 dose to be collected within 15 minutes pre Day 2 dose
Apparent volume of distribution (Vd/F)
PK characteristics after single dose
Measured: Part 1 : Pre- dose to 24 hours , 48 hours post dose, 72 hours post dose Part 2 : Pre- dose to 12 hours, and 24 hours post Day 1 dose to be collected within 15 minutes pre Day 2 dose
Plasma clearance (CL/F)
PK characteristics after single dose
Measured: Part 1 : Pre- dose to 24 hours , 48 hours post dose, 72 hours post dose Part 2 : Pre- dose to 12 hours, and 24 hours post Day 1 dose to be collected within 15 minutes pre Day 2 dos
Plasma elimination half-life (T1/2)
PK characteristics after single dose
Measured: Part 1 : Pre- dose to 24 hours , 48 hours post dose, 72 hours post dose Part 2 : Pre- dose to 12 hours, and 24 hours post Day 1 dose to be collected within 15 minutes pre Day 2 dose
Mean residence time (MRT)
PK characteristics after single dose
Measured: Part 1 : Pre- dose to 24 hours , 48 hours post dose, 72 hours post dose Part 2 : Pre- dose to 12 hours, and 24 hours post Day 1 dose to be collected within 15 minutes pre Day 2 dose
Steady - state peak time (Tmax , ss)
PK characteristics after multiple dose
Measured: Pre- dose to 12 hours, 24 hours post day 1 dose, pre- day 4, pre- day 6， pre- day 7 to 24 hours post day 7 dose, 48 hours post day 7 dose.
Steady-state peak concentration (Cmax , ss)
PK characteristics after multiple dose
Measured: Pre- dose to 12 hours, 24 hours post day 1 dose, pre- day 4, pre- day 6， pre- day 7 to 24 hours post day 7 dose, 48 hours post day 7 dose.
Steady-state trough concentration (Cmin , ss)
PK characteristics after multiple dose
Measured: Pre- dose to 12 hours, 24 hours post day 1 dose, pre- day 4, pre- day 6， pre- day 7 to 24 hours post day 7 dose, 48 hours post day 7 dose
Mean steady-state plasma concentration (Cav,ss)
PK characteristics after multiple dose
Measured: Pre- dose to 12 hours, 24 hours post day 1 dose, pre- day 4, pre- day 6， pre- day 7 to 24 hours post day 7 dose, 48 hours post day 7 dose.
Area under the steady-state plasma concentration-time curve (AUCss)
PK characteristics after multiple dose
Measured: Pre- dose to 12 hours, 24 hours post day 1 dose, pre- day 4, pre- day 6， pre- day 7 to 24 hours post day 7 dose, 48 hours post day 7 dose.
Plasma elimination half-life (T1/2)
PK characteristics after multiple dose
Measured: Pre- dose to 12 hours, 24 hours post day 1 dose, pre- day 4, pre- day 6， pre- day 7 to 24 hours post day 7 dose, 48 hours post day 7 dose.
Fluctuation coefficient between trough and peak drug concentrations (DF)
PK characteristics after multiple dose
Measured: Pre- dose to 12 hours, 24 hours post day 1 dose, pre- day 4, pre- day 6， pre- day 7 to 24 hours post day 7 dose, 48 hours post day 7 dose.
Accumulation ratio R Rac:Cmax
PK characteristics after multiple dose
Measured: Pre- dose to 12 hours, 24 hours post day 1 dose, pre- day 4, pre- day 6， pre- day 7 to 24 hours post day 7 dose, 48 hours post day 7 dose.
Accumulation ratios Rac : AUC
PK characteristics after multiple dose
Measured: Pre- dose to 12 hours, 24 hours post day 1 dose, pre- day 4, pre- day 6， pre- day 7 to 24 hours post day 7 dose, 48 hours post day 7 dose.
Cumulative urinary drug excretion amount (Ae)
Key urinary PK parameters after single dose
Measured: Before dose, 0-12 hours after Day 1 dose, 12-24 hours after Day 1 dose, 24-36 hours after Day 1 dose , 36-48 hours after Day 1 dose, 48-60 hours after Day1 dose, 60-72 hours after Day 1 dose.
Fraction of dose excreted in urine (fe)
Key urinary PK parameters after single dose
Measured: Before dose, 0-12 hours after Day 1 dose, 12-24 hours after Day 1 dose, 24-36 hours after Day 1 dose , 36-48 hours after Day 1 dose, 48-60 hours after Day1 dose, 60-72 hours after Day 1 dose.
Renal clearance (CLR)
Key urinary PK parameters after single dose
Measured: Before dose, 0-12 hours after Day 1 dose, 12-24 hours after Day 1 dose, 24-36 hours after Day 1 dose , 36-48 hours after Day 1 dose, 48-60 hours after Day1 dose, 60-72 hours after Day 1 dose.
Secondary outcomes (2)
Glucose metabolism indicators
Routine glucose metabolism indicators include: FPG, FINS, HOMA-IR, and HOMA-β. Blood samples will be collected to test routine glucose metabolism indicators. The absolute change and percentage change of endpoints relative to baseline will be calculated, and endpoint-time curves will be plotted for each dose cohort.
Measured: Pre-dose blood sample, 0.25 hour post-dose, 0.5 hour, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 12 hours post-dose, 24 hours, 48 hours, 72 hours post-dose.
Lipid metabolism indicators
Routine lipid metabolism indicators include: LDL-C, HDL-C, CHO, TG, etc. Blood samples will be collected to test routine lipid metabolism indicators. The absolute change and percentage change of endpoints relative to baseline will be calculated, and endpoint-time curves will be plotted for each dose cohort.
Measured: Pre-dose blood sample, 0.25 hour post-dose, 0.5 hour, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 12 hours post-dose, 24 hours, 48 hours, 72 hours post-dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start1 Sep 2026
- Primary completion12 Jul 2027 (estimated)
- Study completion10 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult SubjectsStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prospect Therapeutics (Nanjing) Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07752472
- Sponsor's protocol ID
- PSTC100-01-01
- Status last verified
- Sep 2026
- First submitted
- 3 Aug 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PSTC100 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT07752472
- Acronym / sponsor ID
- PSTC100-01-01
- Conditions
- Healthy Adult Subjects
- Keywords
- Phase 1, PSTC100, healthy adult subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Prospect Therapeutics (Nanjing) LimitedIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 12 Jul 2027 (estimated)
- Study completion
- 10 Oct 2027 (estimated)
- First posted
- 7 Aug 2026 (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.
This study is a single-center, randomized, double-blind, placebo-controlled, dose-escalation phase I clinical trial designed to evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic (PD) characteristics of PSTC100 in healthy adult subjects.
Detailed description
This Phase I clinical trial is a randomized, double-blind, placebo-controlled, dose-escalation study consisting of two parts:
Part1: Single Ascending Dose (SAD) study Part2: Multiple Ascending Dose (MAD) study The SAD part employed a randomized, double-blind, placebo-controlled, dose-escalation design to evaluate the safety, tolerability, and PK/PD characteristics of a single dose of 25 mg to 400 mg PSTC100 tablets in healthy adults under fasting conditions.
Part 1 of the study comprises six dose cohorts (A1-A6) with doses of 25 mg, 50 mg, 100 mg, 200 mg, 300 mg, and 400 mg, respectively. Part 1 plans to enroll 46 subjects, with 6 subjects in cohort A1 (4 randomly assigned to the investigational drug and 2 to the placebo) and 8 subjects in each of the other cohorts (6 randomly assigned to the investigational drug and 2 to the placebo).
The MAD part employed a randomized, double-blind, placebo-controlled, and dose-escalation design to evaluate the safety, tolerability, and PK/PD characteristics of once-daily (QD) administration for 7 consecutive days within a dose range of 100 mg to 300 mg PSTC100 tablets in healthy adult subjects.
Part 2 of the study consists of three dose cohorts (A7-A9) with doses of 100 mg, 200 mg, and 300 mg, respectively. Part 2 plans to enroll 24 subjects, with 8 subjects in each cohort (6 randomly assigned to the investigational drug and 2 to the placebo).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A SAD study includes 6 dose cohorts: Cohorts 1-6 | Experimental | Drug: PSTC100 tabletsThis study employed a randomized, double-blind, placebo-controlled, dose-escalation design to evaluate the safety, tolerability, and PK/PD characteristics of a single dose of 25 mg to 400 mg PSTC100 tablets in healthy adults under fasting conditions. |
| A MAD study with randomized, double-blind, placebo-controlled | Experimental | Drug: PSTC100 tabletsThis study includes 3 dose cohorts (Cohorts 7-9): dose 7, dose 8, dose 9 once daily administration. All cohorts receive 7 consecutive days of dosing. This study plans to enroll 24 subjects, with 8 subjects in each cohort (6 randomly assigned to the investigational drug and 2 to the placebo) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 1.Fully understand the purpose and process of this study, voluntarily participate, and sign an informed consent form;
- 2.At the time of screening, applicants must be between 18 and 55 years old (inclusive), and there are no gender restrictions.
- 3.Body mass index (BMI) is between 18.0 and 32.0 kg/m² (inclusive).
- 4.Male participants should weigh no less than 50 kg, and female participants should weigh no less than 45 kg.
- 5.Based on the medical history, vital signs, physical examination, 12-lead electrocardiogram, laboratory tests (hematology, blood biochemistry, coagulation function, urinalysis), and other examination results, the subjects were in good health and no clinically significant abnormalities were found.
Key exclusion criteria (18 listed)
- 1.Pregnant women (or those with a positive pregnancy test), or breastfeeding women;
- 2.During the screening and baseline period, the pulse rate ≤ 45 beats/minute or > 100 beats/minute;
- 3.During the screening and baseline period, systolic blood pressure <90 mmHg or ≥140 mmHg, or diastolic blood pressure <50 mmHg or ≥90 mmHg;
- 4.Those who have special dietary requirements and cannot accept the standardized meals provided by the research center;
- 5.Drinking alcohol or consuming beverages rich in fructose (including but not limited to carbonated soft drinks, 100% fruit/pure juice etc.) or energy drinks during the screening and baseline period may affect blood glucose, lipid profile, or muscle metabolism.
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 |
|---|---|---|
| PSTC100 tabletsPSTC100 tablets | Drug | A SAD study includes 6 dose cohorts: Cohorts 1-6 |
| PSTC100 tabletsdose 7 once daily, dose 8 once daily, dose 9 once daily | Drug | A MAD study with randomized, double-blind, placebo-controlled |
Primary outcome
Time to Peak Concentration (Tmax),
Time frame: Part 1 : Pre- dose to 24 hours , 48 hours post dose, 72 hours post dose Part 2 : Pre- dose to 12 hours, and 24 hours post Day 1 dose to be collected within 15 minutes pre Day 2 dose
PK characteristics after single dose
Peak Concentration (Cmax),
Time frame: Pre- dose to 24 hours , 48 hours post dose, 72 hours post dose Part 2 : Pre- dose to 12 hours, and 24 hours post Day 1 dose to be collected within 15 minutes pre Day 2 dose
PK characteristics after single dose
Area Under the Concentration - Time Curve (AUC0-24h, AUC0-t, AUC0-∞, etc.)
Time frame: Part 1 : Pre- dose to 24 hours , 48 hours post dose, 72 hours post dose Part 2 : Pre- dose to 12 hours, and 24 hours post Day 1 dose to be collected within 15 minutes pre Day 2 dose
PK characteristics after single dose
Apparent volume of distribution (Vd/F)
Time frame: Part 1 : Pre- dose to 24 hours , 48 hours post dose, 72 hours post dose Part 2 : Pre- dose to 12 hours, and 24 hours post Day 1 dose to be collected within 15 minutes pre Day 2 dose
PK characteristics after single dose
Plasma clearance (CL/F)
Time frame: Part 1 : Pre- dose to 24 hours , 48 hours post dose, 72 hours post dose Part 2 : Pre- dose to 12 hours, and 24 hours post Day 1 dose to be collected within 15 minutes pre Day 2 dos
PK characteristics after single dose
Plasma elimination half-life (T1/2)
Time frame: Part 1 : Pre- dose to 24 hours , 48 hours post dose, 72 hours post dose Part 2 : Pre- dose to 12 hours, and 24 hours post Day 1 dose to be collected within 15 minutes pre Day 2 dose
PK characteristics after single dose
Mean residence time (MRT)
Time frame: Part 1 : Pre- dose to 24 hours , 48 hours post dose, 72 hours post dose Part 2 : Pre- dose to 12 hours, and 24 hours post Day 1 dose to be collected within 15 minutes pre Day 2 dose
PK characteristics after single dose
Steady - state peak time (Tmax , ss)
Time frame: Pre- dose to 12 hours, 24 hours post day 1 dose, pre- day 4, pre- day 6， pre- day 7 to 24 hours post day 7 dose, 48 hours post day 7 dose.
PK characteristics after multiple dose
Steady-state peak concentration (Cmax , ss)
Time frame: Pre- dose to 12 hours, 24 hours post day 1 dose, pre- day 4, pre- day 6， pre- day 7 to 24 hours post day 7 dose, 48 hours post day 7 dose.
PK characteristics after multiple dose
Steady-state trough concentration (Cmin , ss)
Time frame: Pre- dose to 12 hours, 24 hours post day 1 dose, pre- day 4, pre- day 6， pre- day 7 to 24 hours post day 7 dose, 48 hours post day 7 dose
PK characteristics after multiple dose
Mean steady-state plasma concentration (Cav,ss)
Time frame: Pre- dose to 12 hours, 24 hours post day 1 dose, pre- day 4, pre- day 6， pre- day 7 to 24 hours post day 7 dose, 48 hours post day 7 dose.
PK characteristics after multiple dose
Area under the steady-state plasma concentration-time curve (AUCss)
Time frame: Pre- dose to 12 hours, 24 hours post day 1 dose, pre- day 4, pre- day 6， pre- day 7 to 24 hours post day 7 dose, 48 hours post day 7 dose.
PK characteristics after multiple dose
Plasma elimination half-life (T1/2)
Time frame: Pre- dose to 12 hours, 24 hours post day 1 dose, pre- day 4, pre- day 6， pre- day 7 to 24 hours post day 7 dose, 48 hours post day 7 dose.
PK characteristics after multiple dose
Fluctuation coefficient between trough and peak drug concentrations (DF)
Time frame: Pre- dose to 12 hours, 24 hours post day 1 dose, pre- day 4, pre- day 6， pre- day 7 to 24 hours post day 7 dose, 48 hours post day 7 dose.
PK characteristics after multiple dose
Accumulation ratio R Rac:Cmax
Time frame: Pre- dose to 12 hours, 24 hours post day 1 dose, pre- day 4, pre- day 6， pre- day 7 to 24 hours post day 7 dose, 48 hours post day 7 dose.
PK characteristics after multiple dose
Accumulation ratios Rac : AUC
Time frame: Pre- dose to 12 hours, 24 hours post day 1 dose, pre- day 4, pre- day 6， pre- day 7 to 24 hours post day 7 dose, 48 hours post day 7 dose.
PK characteristics after multiple dose
Cumulative urinary drug excretion amount (Ae)
Time frame: Before dose, 0-12 hours after Day 1 dose, 12-24 hours after Day 1 dose, 24-36 hours after Day 1 dose , 36-48 hours after Day 1 dose, 48-60 hours after Day1 dose, 60-72 hours after Day 1 dose.
Key urinary PK parameters after single dose
Fraction of dose excreted in urine (fe)
Time frame: Before dose, 0-12 hours after Day 1 dose, 12-24 hours after Day 1 dose, 24-36 hours after Day 1 dose , 36-48 hours after Day 1 dose, 48-60 hours after Day1 dose, 60-72 hours after Day 1 dose.
Key urinary PK parameters after single dose
Renal clearance (CLR)
Time frame: Before dose, 0-12 hours after Day 1 dose, 12-24 hours after Day 1 dose, 24-36 hours after Day 1 dose , 36-48 hours after Day 1 dose, 48-60 hours after Day1 dose, 60-72 hours after Day 1 dose.
Key urinary PK parameters after single dose
2 secondary outcomes
Glucose metabolism indicators
Time frame: Pre-dose blood sample, 0.25 hour post-dose, 0.5 hour, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 12 hours post-dose, 24 hours, 48 hours, 72 hours post-dose.
Lipid metabolism indicators
Time frame: Pre-dose blood sample, 0.25 hour post-dose, 0.5 hour, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 12 hours post-dose, 24 hours, 48 hours, 72 hours post-dose.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: Yes
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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.
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 PSTC100 tablets in people with Healthy Adult Subjects, run by Prospect Therapeutics (Nanjing) Limited 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 7 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 4 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Victor Wong, Doctor (0737072709, v.wong@nucleusnetwork.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Peak Concentration (Tmax), (time frame: Part 1 : Pre- dose to 24 hours , 48 hours post dose, 72 hours post dose Part 2 : Pre- dose to 12 hours, and 24 hours post Day 1 dose to be collected within 15 minutes pre Day 2 dose). The study lists 19 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 4 Sep 2026.