NCT03630627

A Phase I Study of SB26 in Healthy Volunteers

A Randomized, Double-blind, Placebo-controlled, Single and Multiple Rising Dose Study to Explore the Safety, Tolerability, and Pharmacokinetics of Intravenous Doses of SB26 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Samsung Bioepis Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study is a Phase I, randomized double-blind, placebo-controlled (within a dose group), single and multiple rising dose study of the intravenous administration of SB26 in healthy volunteers.

Detailed description

The study includes two Parts; Part 1 includes the FiH exposure and SRD and Part 2 is the MRD. Approximately 58 subjects will be enrolled in the study. New subjects will be recruited for each cohort in both Parts. The SRD Part will include 5 or more dose levels and the MRD Part will include 3 or more dose levels; additional dose level(s) may be added based on emerging safety and PK data from prior cohorts.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	SB26	SB26 administered intravenously
DRUG	Placebo	Placebo administered intravenously

Timeline

• Start date: 2018-08-22
• Primary completion: 2020-04-16
• Completion: 2020-04-16
• First posted: 2018-08-15
• Last updated: 2020-04-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study