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Recruiting
NCT07702279
PSTB100 Study in Healthy Adult Subjects
Conditions: Healthy Adult Subjects
Sex: All
Ages: 18 Years – 55 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 68
Sponsor: Prospect Therapeutics (Nanjing) Limited
Location: Nucleus Network Pty Ltd Brisbane Queensland
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.
Eligibility Criteria
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 \
Source: ClinicalTrials.gov (NCT07702279). StuddyBuddy aggregates publicly available trial information.