A Phase 1 interventional study of SR1375 capsules and Placebo in Healthy, sponsored by Shanghai SIMR Biotechnology Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-29.
Sponsored by Shanghai SIMR Biotechnology Co., Ltd. · Phase 1, Interventional, and Treatment
This is a randomized, double-blind, placebo-controlled phase I bridging study to evaluate the PK, PD, safety and tolerability of SR1375 in healthy subjects.
The study is a Phase I study to evaluate the PK, PD, safety, and tolerability of SR1375 in healthy volunteers. The study will include 3 single-ascending-dose (SAD) cohorts and 1 multiple-dose cohorts (Part A and part B respectively), a total of 4 cohorts, and each cohort includes 3 stages: screening and baseline, treatment and safety monitoring, and safety follow-up.
Shanghai SIMR Biotechnology Co., Ltd. is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Healthy female volunteers must be:
i. Of non-childbearing potential(with a documented tubal ligation, bilateral salpingectomy, hysterectomy, or menopause for more than 1 year) ii. Of childbearing potential, must have a negative pregnancy test at the screening visit (blood test), must agree to use a highly effective contraceptive method from signing the consent form until at least 30 days after the last dose of study drug.
Exclusion Criteria:
Except for topical (no significant systemic exposure) permitted, use of the following combination agents will be excluded:
History of regular alcohol consumption within 6 months of screening defined as:
an average weekly intake of >14 units (1 unit of alcohol ≈360 mL beer or 45 mL 40% alcohol spirits or 150 mL wine), or abstain from alcohol during the study.
Ascending single and multiple doses of SR1375 orally
Drug: SR1375 capsules
Ascending single and multiple doses of SR1375 placebo orally
Other: Placebo
Ascending single and multiple doses of SR1375 orally
Ascending single and multiple doses of Placebo orally
Cmax
Peak plasma concentration
Time frame: On scheduled intervals from Day 1 up to Day 54
Tmax
Time of peak plasma concentration
Time frame: On scheduled intervals from Day 1 up to Day 54
AUC
Area under the plasma concentration-time curve
Time frame: On scheduled intervals from Day 1 up to Day 54
CL/F
Apparent oral clearance
Time frame: On scheduled intervals from Day 1 up to Day 54
t1/2
Terminal half-life
Time frame: On scheduled intervals from Day 1 up to Day 54
Rac
Accumulation ratio
Time frame: On scheduled intervals from Day 1 up to Day 54
The frequency and severity of AEs in healthy volunteers administrated with single and repeated oral doses of SR1375 capsules
AE: Adverse Event
Time frame: On scheduled intervals from Day 1 up to Day 54
PAF-AH
Platelet activating factor acetylhydrolase
Time frame: On scheduled intervals from Day 1 up to Day 54
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Shanghai SIMR Biotechnology Co., Ltd.