NCT06026397

A Sequential Single and Multiple Ascending Dose (SAD/MAD) Study of SK10 Powders in Healthy Adult Subjects

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Guangzhou Zhiyi Biotechnology Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Chemotherapy-induced Diarrhea

Interventions

Type	Name	Description
DRUG	SK10	Participants will be randomized to receive oral suspension of SK10 powder, includes SAD on Day 1 and 14-days MAD from Day 4 to Day 17.
DRUG	Placebo	Participants will be randomized to receive oral suspension of placebo, includes SAD on Day 1 and 14-days MAD from Day 4 to Day 17.

Timeline

• Start date: 2023-08-01
• Primary completion: 2024-02-11
• Completion: 2024-02-11
• First posted: 2023-09-07
• Last updated: 2024-02-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study