Chemotherapy-induced Diarrhea Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled, Sequential Dose-escalation Clinical Study to Evaluate the Safety and Tolerability of SK10 Powders (Inactivated Bacteroides Fragilis) in Healthy Adult Subjects
The purpose of this study is to assess the safety and tolerability of orally administered SK10 powders in healthy adult subjects at three dose levels, following single and multiple doses.
This is a first-in-human, Phase 1, randomized, double-blind, placebo-controlled, sequential SAD and MAD study to assess the safety and tolerability of orally administered SK10 powders in healthy adult subjects. This is a dose escalation study with three sequential cohorts planned testing at 3 dose levels. A total of 24 subjects are planned to be enrolled into 3 cohorts (Cohorts 1, 2 and 3). Within each cohort, eligible subjects will be randomized to receive SK10 or placebo in a 3:1 ratio. The treatment duration includes a single dose administration on Day 1 and 14-day repeat doses administration from Day 4 to Day 17. The study consists of: - Screening Period (28 days [Day -28 to Day -1]) - Treatment Period (Day -1 to Day 19) - Follow-up Visit (Day 24). The study duration will be approximately up to 52 days, conducted at a single center. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00582426 -
Evaluation of Octreotide LAR in Prevention of Chemotherapy-induced Diarrhea
|
Phase 3 |