PSTC100 study in healthy adults (Phase 1)
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
Run by Prospect Therapeutics (Nanjing) Limited · NCT07752472 · Data updated 2026-11-12
A Phase 1 study in healthy adults tests PSTC100 across increasing single and multiple doses to see if it is safe and how the body handles the drug.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Enrollment | 70 (estimated) |
| Sponsor | Prospect Therapeutics (Nanjing) Limited Industry-sponsored |
| Locations | 1 site (Saint Leonards, New South Wales) |
| Status | Recruiting |
| Started | September 1, 2026 |
| Main results expected | July 12, 2027 |
| Study ends | October 10, 2027 |
| Registry record updated | September 4, 2026 |
| Trial ID | NCT07752472 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy adults aged 18 to 55 with BMI 18.0–32.0 kg/m² and no significant medical findings.
✕Probably not a fit
Individuals with health issues or conditions that affect drug metabolism or contraindications to PSTC100 may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-center, randomized, double-blind, placebo-controlled, dose-escalation Phase 1 trial of PSTC100 in healthy adults. It has two parts: Part 1 tests single ascending doses from 25 mg to 400 mg, and Part 2 tests once-daily dosing from 100 mg to 300 mg for seven days. The study will compare PSTC100 to placebo and will collect safety, tolerability, and pharmacokinetic/pharmacodynamic data. Enrollment includes two cohorts per dose in Part 1 (with more subjects per cohort) and three cohorts in Part 2, totaling approximately 70 participants. The trial is conducted at a single site with Prospect Therapeutics as lead sponsor.
Why it matters
Potential benefit: If successful, PSTC100 could provide foundational safety and PK/PD data to support future efficacy studies.
How similar studies have gone: Phase 1 studies of similar compounds have shown that careful dose-escalation can establish safety and PK/PD profiles in healthy volunteers.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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.
Where it's running
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Nucleus Network Sydney Pty Ltd
Saint Leonards, New South Wales, Australia Recruiting
Study contacts
- Study coordinator: Victor Wong, Doctor
- Email: v.wong@nucleusnetwork.com.au
- Phone: 0737072709
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.