IND Approval for Phase 1 Bioequivalence Study of SKI-O-703 (Formulation Change)

Obtained IND approval from MFDS for a Phase 1 bioequivalence (BE) study of SKI-O-703
Study will enroll 48 healthy subjects with an open-label, randomized, postprandial, single-dose, 2-period crossover design
Primary endpoints: pharmacokinetics (AUCt, Cmax) and safety (adverse events, vital signs, etc.)
Target indications: rheumatoid arthritis and immune thrombocytopenia (ITP); estimated completion by May 20, 2027
This IND is for a formulation change; clinical trial success probability is statistically about 10% (investment caution noted)

Filing: Major Management Matters Related to Investment Decision (Decision on Clinical Trial Plan Approval Application, etc.) (Phase 1 Clinical Trial IND Approval for Change in Drug Formulation of SKIO703)
Company: OSCOTEC (039200)
Submission: OSCOTEC Inc.
Receipt: 05-22-2026
Under KRX KOSDAQ Market Division