← Back to all trials
Recruiting
NCT07752472
PSTC100 Study in Healthy Adult Subjects
Conditions: Healthy Adult Subjects
Sex: All
Ages: 18 Years – 55 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 70
Sponsor: Prospect Therapeutics (Nanjing) Limited
Location: Nucleus Network Sydney Pty Ltd Saint Leonards New South Wales
Summary
This study is a single-center, randomized, double-blind, placebo-controlled, dose-escalation phase I clinical trial designed to evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic (PD) characteristics of PSTC100 in healthy adult subjects.
Eligibility 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 \
Source: ClinicalTrials.gov (NCT07752472). StuddyBuddy aggregates publicly available trial information.