PSTB100 Study in Healthy Adult Subjects
ConditionHealthy Adult Subjects
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorProspect Therapeutics (Nanjing) Limited
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
1.Healthy subjects aged 18-55 years (inclusive) at screening, with no gender restriction.
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).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
PSTB100 tablets
DrugPSTB100 tablets
PSTB100 tablets
Drugdose 1 once daily， dose 2 once daily， dose 3 once daily
Treatment groups
68 Participants
are divided into 2 treatment groupsGroup A: A SAD study includes 5 predefined cohorts: Cohorts 1-5Experimental treatment 1 intervention
Group B: A MAD study with randomized, double-blind, placebo-controlledExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Time to Reach Maximum Observed Plasma concentration (Tmax)
PK characteristics after single dose
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 dose2
Maximum Observed PSTB100 Plasma Concentration (Cmax)
PK characteristics after single dose
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 dose3
PSTB100 area under the plasma concentration-time curve (AUC0-24h, AUC0-t, AUC0-∞, etc.)
PK characteristics after single dose
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 dose4
Plasma clearance (CL/F)
PK characteristics after single dose
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 doseSecondary outcomes
1
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)
Time frame
Pre- dose to 24 hours , 48 hours post dose, 72 hours post dose2
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.
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-dose3
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.
Time frame
1 hours post-Day 7 dose, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours post Day 7 doseSponsors and contacts
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Source ClinicalTrials.gov