A Phase 1 interventional study of ASC42 and Placebo in Healthy, sponsored by Ascletis Pharmaceuticals Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-30.
Sponsored by Ascletis Pharmaceuticals Co., Ltd. · Phase 1, Interventional, and Other
This is a Phase I Randomized, Double-Blind, Placebo-Controlled, Dose Escalation, Single Center Bridging Study to Evaluate Safety, Tolerability and Pharmacokinetics of ASC42 in Chinese Healthy Subjects.
Ascletis Pharmaceuticals Co., Ltd. is the lead sponsor of 24 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
ASC42 tablet Dose A, once daily
Drug: ASC42
Placebo Comparator: Single dose of matched placebo to ASC42 tablet Dose A, once daily
Drug: Placebo
ASC42 tablet Dose B, once daily
Drug: ASC42
Placebo Comparator: Single dose of matched placebo to ASC42 tablet Dose A, once daily
Drug: Placebo
ASC42 tablet administered orally
Matching placebo administered orally
AUC of ASC42
Evaluate the Area under the plasma concentration versus time curve.
Time frame: Up to 4 days
Cmax of ASC42
Evaluate the Peak Plasma Concentration.
Time frame: Up to 4 days
t1/2 of ASC42
Evaluate the Terminal-Phase Half-Life.
Time frame: Up to 4 days
CL/F of ASC42
Evaluate the Apparent Systemic Clearance.
Time frame: Up to 4 days
Vd/F of ASC42
Evaluate the Apparent Volume of Distribution.
Time frame: Up to 4 days
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Occurrence of Serious Adverse Event (SAE), Adverse Event (AE) resulting in treatment discontinuation and/or dose reductions, and AE of special interest, from baseline up to 7 days.
Time frame: Up to 7 days
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Ascletis Pharmaceuticals Co., Ltd.