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Ascletis Announces Positive Topline Results from U.S. Phase I Study of ASC50, a Potential Best-in-Class Oral Small Molecule IL-17 Inhibitor
Ascletis Pharma Inc. (HKEX:1672, "Ascletis") announces positive topline results from a randomized, double-blind, placebo-controlled Phase I clinical trial in the U.S., evaluating the safety, tolerability, pharmacokinetics and peripherally circulating interleukin-17A (IL-17A) target engagement profile of ASC50 (NCT07024602) in a single ascending dose (SAD) study in healthy participants. Forty-six healthy participants received 10 mg, 30 mg, 100 mg, 200 mg, 400 mg, or 600 mg of ASC50 or matching pl
About this update from Ascletis Pharma, Inc.
[{"type":"text","content":"- The elimination half-life of ASC50 after a single oral dose was 43, 89, 91, 87, 104, and 85 hours for 10 mg, 30 mg, 100 mg, 200 mg, 400 mg, and 600 mg, respectively, supporting once-daily or potentially once-weekly oral dosing.","length":229,"tagName":"p"},{"type":"text","content":"- ASC50 had strong target engagement after a single oral dose, indicated by elevated plasma interleukin-17A (IL-17A) levels, which continued until day 7 for higher doses of ASC50.","length":179,"tagName":"p"},{"type":"text","content":"- ASC50 demonstrated a dose-proportional pharmacokinetic profile from 10 mg to 600 mg in single ascending dose study in healthy participants.","length":141,"tagName":"p"},{"type":"text","content":"- ASC50 was safe and well tolerated at all dose levels.","length":55,"tagName":"p"},{"type":"text","content":"- The Company will host a conference call in Mandarin at 8:00 p.m. China Standard Time on December 15, 2025. ","length":108,"tagName":"p"},{"type":"text","content":"HONG KONG, Dec. 15, 2025 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX:1672, "Ascletis") announces positive topline results from a randomized, double-blind, placebo-controlled Phase I clinical trial in the U.S., evaluating the safety, tolerability, pharmacokinetics and peripherally circulating interleukin-17A (IL-17A) target engagement profile of ASC50 (NCT07024602) in a single ascending dose (SAD) study in healthy participants. Forty-six healthy participants received 10 mg, 30 mg, 100 mg, 200 mg, 400 mg, or 600 mg of ASC50 or matching placebo. The objectives of the study included safety, tolerability, pharmacokinetics and target engagement.","length":671,"tagName":"p"},{"type":"text","content":"Key Findings","length":12,"tagName":"p"},{"type":"list","items":[{"val":[{"type":"text","content":"The elimination half-life of ASC50 after a single oral dose was 43, 89, 91, 87, 104, and 85 hours for 10 mg, 30 mg, 100 mg, 200 mg, 400 mg, and 600 mg, respectively, supporting once-daily or potentially once-weekly oral dosing.","length":227,"tagName":"p"}]},{"val":[{"type":"text","content":"ASC50 had strong target engagement after a single oral dose, indicated by elevated plasma IL-17A levels, which continued until day 7 for higher doses of ASC50.","length":159,"tagName":"p"}]},{"val":[{"type":"text","content":"ASC50 demonstrated a dose-proporti...