NCT02446340

Multiple Ascending Dose Safety Study of ShK-186 (Dalazatide) in Healthy Volunteers

A Double-Blind, Placebo-Controlled Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of ShK-186

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Kineta Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to examine safety outcomes in healthy volunteers after systemic administration of multiple ascending doses of dalazatide.

Detailed description

The purpose of this study is to examine safety outcomes in healthy volunteers after systemic administration of multiple ascending doses of dalazatide delivered via subcutaneous injection twice per week for a total of 9 doses.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	dalazatide	Different doses of drug, subcutaneous injection twice per week for a total of 9 doses.
DRUG	placebo	Placebo delivered via subcutaneous administration twice per week for a total of 9 doses

Timeline

• Start date: 2013-11-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2015-05-18
• Last updated: 2015-05-18

Locations

1 site across 1 country: United States