SK10 / Zhiyi Biotech - LARVOL DELTA

A Sequential Single and Multiple Ascending Dose (SAD/MAD) Study of SK10 Powders in Healthy Adult Subjects (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Guangzhou Zhiyi Biotechnology Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion

A Sequential Single and Multiple Ascending Dose (SAD/MAD) Study of SK10 Powders in Healthy Adult Subjects (clinicaltrials.gov) - P1 | N=24 | Active, not recruiting | Sponsor: Guangzhou Zhiyi Biotechnology Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed

A Sequential Single and Multiple Ascending Dose (SAD/MAD) Study of SK10 Powders in Healthy Adult Subjects (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Guangzhou Zhiyi Biotechnology Co., Ltd.

New P1 trial

Zhiyi Biotech Announced First Subject Dosed in the U.S. Phase 1 clinical Trial of SK10, in Development for Treatment of Chemotherapy-induced Diarrhea (PRNewswire) - "On August 23rd 2023, Zhiyi Biotech announced that the first three subjects have been dosed in the U.S. Phase 1 clinical trial of SK10, an innovative heat-killed Bacteroides fragilis product developed by Zhiyi Biotech for Chemotherapy-induced Diarrhea (CID). The U.S. Phase 1 trial is a First-in-Human study of SK10, designed as a randomized, double-blind, placebo-controlled, sequential dose-escalation study to evaluate the safety and tolerability of SK10 in healthy adult subjects. The study is anticipated to enroll 24 healthy subjects to sequentially test three ascending doses of orally administered SK10."

Trial status • Oncology