PSTC100 Study in Healthy Adult Subjects

NCT07752472 | Recruiting Phase 1 DMC

• 1 other identifier: PSTC100-01-01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Adult Subjects

Keywords

Phase 1; PSTC100; healthy adult subjects

Outcome Measures

Primary Outcomes (19)

• Time to Peak Concentration (Tmax),

  PK characteristics after single dose

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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.

Study Arms (2)

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.

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)

Drug: PSTC100 tablets

Interventions

PSTC100 tablets DRUG

PSTC100 tablets

A SAD study includes 6 dose cohorts: Cohorts 1-6

Eligibility Criteria

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

You may qualify if:

• Fully understand the purpose and process of this study, voluntarily participate, and sign an informed consent form;
• At the time of screening, applicants must be between 18 and 55 years old (inclusive), and there are no gender restrictions.
• Body mass index (BMI) is between 18.0 and 32.0 kg/m² (inclusive).
• Male participants should weigh no less than 50 kg, and female participants should weigh no less than 45 kg.
• 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.
• 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.
• 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.

You may not qualify if:

• Pregnant women (or those with a positive pregnancy test), or breastfeeding women;
• During the screening and baseline period, the pulse rate ≤ 45 beats/minute or \> 100 beats/minute;
• During the screening and baseline period, systolic blood pressure \<90 mmHg or ≥140 mmHg, or diastolic blood pressure \<50 mmHg or ≥90 mmHg;
• Those who have special dietary requirements and cannot accept the standardized meals provided by the research center;
• 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.
• 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.
• 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;
• Suspected or confirmed allergy to any component of the investigational drug, or a confirmed history of severe allergy;
• 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).
• 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.
• Those who have lost or donated more than 400 mL of blood within the 1 month prior to screening (excluding physiological blood loss);
• Those who have participated in any clinical trials within the 3 months prior to screening (excluding those who failed the screening);
• 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;
• 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;
• 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;

Sponsors & Collaborators

• Prospect Therapeutics (Nanjing) Limited: lead

Study Sites (1)

Nucleus Network Sydney Pty Ltd

Saint Leonards, New South Wales, 2065, Australia

RECRUITING

Central Study Contacts

Victor Wong, Doctor

CONTACT

0737072709; v.wong@nucleusnetwork.com.au

Alice Hu

CONTACT

1800 243 733; ausethicsandregulatory@nucleusnetwork.com.au

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2026
• First Posted: August 7, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): July 12, 2027
• Study Completion (Estimated): October 10, 2027
• Last Updated: September 4, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share

Locations

AU (1)