First human trial launches for experimental PSTB100 drug

NCT ID NCT07702279

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 14, 2026 · Last updated Sep 04, 2026 · Updated 4 times

Summary

This first-in-human study tests the safety and tolerability of PSTB100 tablets in healthy adults aged 18 to 55. Participants receive either a single or multiple doses of the drug or a placebo. Researchers measure how the body absorbs, processes, and eliminates PSTB100 to guide future studies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
PSTB100 tablets
What this could lead to
If successful, this early study could pave the way for future trials exploring PSTB100 as a potential treatment.
What could go wrong
This is a very early Phase 1 trial focused on safety and dosing in healthy people, not on treating any disease. It may not lead to any therapeutic benefit.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 68 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 1.Healthy subjects aged 18-55 years (inclusive) at screening, with no gender restriction. Cohort 8 will enroll only male subjects aged 18-45 years (inclusive) at screening. * 2.Body Mass Index (BMI) of 18.0 to 32.0 kg/m² (inclusive), and 19.0 to 26.0 kg/m² (inclusive) for Cohort 8. * 3.Good health status confirmed by medical history, vital signs, physical examination, 12-lead ECG, laboratory tests (blood routine, biochemistry, coagulation function, urinalysis), etc., with no clinically significant abnormalities. * 4.Fully informed about the study, voluntary participation, and signed Informed Consent Form (ICF). * 5\. Women of childbearing potential who have no pregnancy plan from the screening period until 1 month after the end of the trial, and agree to use contraceptive methods as detailed further in the protocol (see Appendix 3) from signing the ICF until 30 days after last dose. * 6.Males who agree to use contraception as detailed further in the protocol (see Appendix 3) with partners of childbearing potential from signing ICF until 90 days after last dose. Exclusion Criteria: * 1.Females who are pregnant (positive or clinically abnormal pregnancy test result), lactating, or planning to become pregnant. * 2.Pulse rate ≤50 beats/min or \>100 beats/min at screening. * 3.Systolic blood pressure \<90 mmHg or ≥140 mmHg, or diastolic blood pressure \<60 mmHg or ≥90 mmHg at screening. * 4.History or current presence of clinically significant diseases or abnormalities in cardiovascular, respiratory, digestive, endocrine, metabolic, neurological, dermatological, ophthalmological, infectious, or psychiatric systems, including but not limited to history of eczema, no use of steroid creams for 3 months prior to screening; 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. Subjects with previous non-severe diseases or cured acute diseases may be enrolled if the assessor confirms no impact on the clinical trial. * 5.Use of tobacco, coffee, St. John's wort, grapefruit, grapefruit juice, cranberry juice, or strenuous exercise within 24 hours before enrollment. * 6.6.Suspected or confirmed allergy to any ingredient of the investigational product, or any known allergy history (however, subjects with mild allergies such as to pollen, cats or dust, which is fully resolved or without any treatment for more than 3 years can be enrolled). * 7.Previous surgery that may affect the clinical trial results (including but not limited to cholecystectomy, subtotal gastrectomy; excluding minor surgeries such as subcutaneous lipoma resection). 8.Use of any medication within 14 days before the study drug administration, including over-the-counter drugs and herbal medicines (except vitamins and calcium tablets), or dietary supplement within 7 days before the study drug administration. * 9.Blood loss or blood donation exceeding 400 mL within 30 days before screening (physiological blood loss excluded). * 10.Participation in any clinical trial of investigational drugs or medical devices within 3 months (or within 5 half-lives of investigational drugs, whichever is longer) before screening (excluding subjects who failed screening). * 11.History of alcohol abuse. Subjects who consumed more than 14 standard alcohol units weekly within the past year (1 standard unit ≈ 250 mL of 5% beer; 100 mL of 12.5% wine; 30 mL of 42% spirits) or who refuse to abstain from alcohol during the trial. * 12.History of smoking abuse (average ≥ 5 cigarettes daily within 1 month before screening) or refusal to abstain from smoking during the trial. * 13.History of drug abuse or positive urine drug screening result during screening (subjects with positive cotinine at screening \[D-28\~D-2\] will be not excluded if a negative cotinine is obtained on D-1). * 14.Breath alcohol test with positive result at screening. * 15.Clinically abnormal results of HBsAg, anti-HBcAb, anti-TP (if applicable), anti-HCV, anti-HIV, or QuantiFERON Gold. * 16.History of severe/serious bacterial infection, recurrent (\>3× per year) bacterial infections, or herpes simplex virus (HSV) infection. * 17.Subjects who received live vaccine within 4 weeks of screening, or plan to receive live vaccine during and up to 4 weeks after the last dose of investigational product. * 18.Subjects for Cohort 8 will be excluded if: * Experienced cold, infection, etc., within 4 weeks before screening. * Have contraindications or are unsuitable for lumbar puncture. * 19\. Any other situation that the researcher considers may bring safety risks to the subject, interfere with the study, or that the subject may not complete the study or comply with the requirements (due to management reasons, dysphagia, or other reasons).

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Nucleus Network Pty Ltd

    RECRUITING

    Brisbane, Queensland, 4006, Australia

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