Healthy Adult SubjectsPhase 1NCT07702279
PSTB100 Study in Healthy Adult Subjects
A Phase 1 study testing PSTB100 tablets in people with Healthy Adult Subjects, run by Prospect Therapeutics (Nanjing) Limited at 1 site in Australia.
Trial summary
This study is a randomized, double-blind, placebo-controlled, dose-escalation， first-in-human clinical trial in healthy adults, designed to assess the safety, tolerability, and PK characteristics of PSTB100 tablets. 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?
- PSTB100 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteAustralia
- Study dates
- 14 Jul 2026to 6 Sep 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.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.
Who cannot join
- 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.
Show all 22Show fewer
- 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).
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 Pty Ltd
Brisbane, Queensland, 4006
Gloria Wong, Doctor, 0430 891 636, g.wong@nucleusnetwork.com.au
Gloria Wong, Doctor
About this study
Official title: A Phase I Clinical Study of Safety, Tolerability, and Pharmacokinetics / Pharmacodynamics of Single and Multiple Ascending Doses of PSTB100 Tablets in Healthy Adult Subjects
This study is a randomized, double-blind, placebo-controlled, dose-escalation， first-in-human clinical trial in healthy adults, designed to assess the safety, tolerability, and PK characteristics of PSTB100 tablets.
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 uses a single-center, randomized, double-blind, placebo-controlled, dose-escalation design to evaluate the safety, tolerability, and PK/PD profile of single oral doses of PSTB100 Tablets under fasting conditions in healthy adult subjects.
The MAD part uses a single-center, randomized, double-blind, placebo-controlled, dose-escalation design to evaluate the safety, tolerability, and PK/PD profile of multiple oral doses of PSTB100 Tablets in healthy adults.
In addition, one dose cohort (expected to be Cohort 8) will include assessments of PK/PD changes of PSTB100 in cerebrospinal fluid (CSF) after repeated dosing.
- Conditions
- Healthy Adult Subjects
- Being tested
- PSTB100 tablets
- Keywords
- Phase I, PSTB100, healthy adult subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSTB100 tabletsDrug
PSTB100 tablets
PSTB100 tabletsDrug
dose 1 once daily， dose 2 once daily， dose 3 once daily
| Study group | Role | What they receive |
|---|---|---|
| A SAD study includes 5 predefined cohorts: Cohorts 1-5 | Experimental | The Single Ascending Dose (SAD) study uses a single-center, randomized, double-blind, placebo-controlled, dose-escalation design to evaluate the safety, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) characteristics of a single oral dose of PSTB100 Tablets in healthy adult subjects under fasting conditions. Receives: Drug: PSTB100 tablets |
| A MAD study with randomized, double-blind, placebo-controlled | Experimental | The MAD study includes 3 predefined dose cohorts (Cohorts 6-8)， All cohorts receive 7 consecutive days of dosing. Cohorts 6, 7: 8 subjects each (6 active, 2 placebo) Cohort 8: 14 subjects (12 active, 2 placebo) Receives: Drug: PSTB100 tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Reach Maximum Observed Plasma 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
Maximum Observed PSTB100 Plasma Concentration (Cmax)
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
PSTB100 area under the plasma 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
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 dose
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 time to peak (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.
Average 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.
Fluctuation factor (DF) between trough and peak concentrations;
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: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.
Secondary outcomes (3)
Plasma Metabolite Identification
Metabolite identification and relative abundance analysis will be performed in plasma samples from one cohort (expected to be a dose cohort within SAD Cohort 4 or 5, and sampling time points are same as PK blood sampling time points)
Measured: Pre- dose to 24 hours , 48 hours post dose, 72 hours post dose
Inflammatory Cytokine Markers
PD biomarkers related to systemic inflammation，including IP-10, hsCRP, IFN-β, and IL-6. Absolute and percentage changes from baseline will be calculated, and PD marker-time profiles will be plotted by dose cohort.
Measured: Pre-dose PD blood sample (before first dose): to be collected within 1 hour pre-dose Pre-dose PD blood sample (before subsequent doses): to be collected within 15 minutes pre-dose
Cerebrospinal fluid (CSF)
CSF samples will be collected to measure PSTB100 concentrations in Cohort 8. The CSF-to-plasma concentration ratio (C/P ratio) will be calculated, and a C/P-time profile will be constructed. The CSF concentration-time profile will be derived from this ratio and the corresponding plasma concentration-time profile.
Measured: 1 hours post-Day 7 dose, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours post Day 7 dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start14 Jul 2026
- Primary completion12 Jun 2027 (estimated)
- Study completion6 Sep 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
- 68 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
- NCT07702279
- Sponsor's protocol ID
- PSTB100-01-01
- Status last verified
- Aug 2026
- First submitted
- 27 Jun 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 Clinical Study of Safety, Tolerability, and Pharmacokinetics / Pharmacodynamics of Single and Multiple Ascending Doses of PSTB100 Tablets in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT07702279
- Acronym / sponsor ID
- PSTB100-01-01
- Conditions
- Healthy Adult Subjects
- Keywords
- Phase I, PSTB100, healthy adult subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Prospect Therapeutics (Nanjing) LimitedIndustry (pharma, biotech, devices)
- Study start
- 14 Jul 2026 (actual)
- Primary completion
- 12 Jun 2027 (estimated)
- Study completion
- 6 Sep 2027 (estimated)
- First posted
- 14 Jul 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 randomized, double-blind, placebo-controlled, dose-escalation， first-in-human clinical trial in healthy adults, designed to assess the safety, tolerability, and PK characteristics of PSTB100 tablets.
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 uses a single-center, randomized, double-blind, placebo-controlled, dose-escalation design to evaluate the safety, tolerability, and PK/PD profile of single oral doses of PSTB100 Tablets under fasting conditions in healthy adult subjects.
The MAD part uses a single-center, randomized, double-blind, placebo-controlled, dose-escalation design to evaluate the safety, tolerability, and PK/PD profile of multiple oral doses of PSTB100 Tablets in healthy adults.
In addition, one dose cohort (expected to be Cohort 8) will include assessments of PK/PD changes of PSTB100 in cerebrospinal fluid (CSF) after repeated dosing.
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 5 predefined cohorts: Cohorts 1-5 | Experimental | Drug: PSTB100 tabletsThe Single Ascending Dose (SAD) study uses a single-center, randomized, double-blind, placebo-controlled, dose-escalation design to evaluate the safety, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) characteristics of a single oral dose of PSTB100 Tablets in healthy adult subjects under fasting conditions. |
| A MAD study with randomized, double-blind, placebo-controlled | Experimental | Drug: PSTB100 tabletsThe MAD study includes 3 predefined dose cohorts (Cohorts 6-8)， All cohorts receive 7 consecutive days of dosing. Cohorts 6, 7: 8 subjects each (6 active, 2 placebo) Cohort 8: 14 subjects (12 active, 2 placebo) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (22 listed)
- 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.
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 |
|---|---|---|
| PSTB100 tabletsPSTB100 tablets | Drug | A SAD study includes 5 predefined cohorts: Cohorts 1-5 |
| PSTB100 tabletsdose 1 once daily， dose 2 once daily， dose 3 once daily | Drug | A MAD study with randomized, double-blind, placebo-controlled |
Primary outcome
Time to Reach Maximum Observed Plasma 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
Maximum Observed PSTB100 Plasma Concentration (Cmax)
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
PSTB100 area under the plasma 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
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 dose
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 time to peak (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
Average 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
Fluctuation factor (DF) between trough and peak concentrations;
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: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
3 secondary outcomes
Plasma Metabolite Identification
Time frame: Pre- dose to 24 hours , 48 hours post dose, 72 hours post dose
Inflammatory Cytokine Markers
Time frame: Pre-dose PD blood sample (before first dose): to be collected within 1 hour pre-dose Pre-dose PD blood sample (before subsequent doses): to be collected within 15 minutes pre-dose
Cerebrospinal fluid (CSF)
Time frame: 1 hours post-Day 7 dose, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours post Day 7 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.
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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 PSTB100 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 22 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Reach Maximum Observed Plasma 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 14 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.