NCT03097341

Safety and Tolerability Study of Xisomab 3G3 in Healthy Adult Subjects

A Phase 1, Single Ascending Dose, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Xisomab 3G3 in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Aronora, Inc. · Industry
• Sex: All
• Age: 18 Years – 48 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of xisomab 3G3 in healthy adult subjects.

Conditions

• Thrombosis

Interventions

Type	Name	Description
DRUG	xisomab 3G3- Dose 1	Participants will receive a single intravenous dose of 0.1 mg/kg xisomab 3G3.
DRUG	xisomab 3G3-Dose 2	Participants will receive a single intravenous dose of 0.5 mg/kg xisomab 3G3.
DRUG	xisomab 3G3-Dose 3	Participants will receive a single intravenous dose of 2.0 mg/kg xisomab 3G3.
DRUG	xisomab 3G3- Dose 4	Participants will receive a single intravenous dose of 5.0 mg/kg xisomab 3G3.
OTHER	Placebo	Participants will receive a single intravenous dose of placebo.

Timeline

• Start date: 2017-06-05
• Primary completion: 2018-01-16
• Completion: 2018-01-16
• First posted: 2017-03-31
• Last updated: 2019-06-05
• Results posted: 2019-05-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study