CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 21 enrolled
Drug / intervention
xisomab 3G3- Dose 1 +4 moredrug
Likely dose
xisomab 3G3- Dose 1 0.1 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03097341
NCT03097341Phase 1Completed
CompareCT.gov

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

Aronora, Inc.·interventional·Posted Mar 31, 2017·Updated Jun 5, 2019

In Brief

A Phase 1 clinical trial evaluating xisomab 3G3- Dose 1, xisomab 3G3-Dose 2, and 3 other interventions for Thrombosis. Completed, enrolled 21 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsThrombosis
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 31, 2017
Enrollment StartJun 5, 2017
Primary CompletionJan 16, 2018
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 9.3 years ago

Interventions

xisomab 3G3- Dose 1drug

Participants will receive a single intravenous dose of 0.1 mg/kg xisomab 3G3.

xisomab 3G3-Dose 2drug

Participants will receive a single intravenous dose of 0.5 mg/kg xisomab 3G3.

xisomab 3G3-Dose 3drug

Participants will receive a single intravenous dose of 2.0 mg/kg xisomab 3G3.

xisomab 3G3- Dose 4drug

Participants will receive a single intravenous dose of 5.0 mg/kg xisomab 3G3.

Placeboother

Participants will receive a single intravenous dose of placebo.