Shanghai Clinical Research Center Phase I Clinical Research Unit (SCRC-PCRU)
Shanghai, China
NCT Number: NCT05753033
This is a randomized, double-blind, placebo-controlled phase I PK bridging study to evaluate the PK, safety and tolerability of SR750 in healthy subjects.
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Notify Me18 year–45 year
All sexes
Interventional
Phase 1
Shanghai, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Use of medication other than topical products without significant systemic absorption.
Ascending single and multiple doses of SR750 orally
Ascending single and multiple doses of placebo orally
Time frame: Up to Day 9
Peak plasma concentration
Time frame: Up to Day 9
Time of peak plasma concentration
Time frame: Up to Day 9
Area under the plasma concentration-time curve
Time frame: Up to Day 9
Apparent oral clearance
Time frame: Up to Day 9
Terminal half-life
Time frame: Up to Day 9
Accumulation ratio
Time frame: Up to Day14(+7 days) for the safety follow up since Day1
The frequency and severity of althy volunteers administrated with single and repeated oral doses of SR750 AEs
Shanghai SIMR Biotechnology Co., Ltd.
Industry
A Phase I Bridging Study to Evaluate the PK, Safety and Tolerability of SR750 in Healthy Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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