A Single Infusion Study of DUR-928 in Healthy Volunteers

Phase 1

Completed

• Conditions: Acute Kidney Injury; Renal and Urogenital - Other renal and urogenital disorders

• Registration Number: ACTRN12616000856415
• Lead Sponsor: INC Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-06-30
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Be in good health as determined by medical history, physical examination, 12 lead ECG and clinical laboratory evaluations at screening;
Weight at least 50kg and BMI between 18.0 kg/m2 and 30.0 kg/m2, inclusive;
Male subjects must agree to use a medically acceptable method of contraception/birth control throughout the study duration and for 90 days after the study is completed;
Female subjects must be of non-childbearing potential;
Willing and be able to be admitted to the clinical study unit for 3 nights and 2 days;
Able to abstain from alcohol and tobacco use during the trial.

Exclusion Criteria

Significant blood loss or donated blood in the 30 days prior to study participation
Participation in an investigational drug study within 30 days prior to dosing.
History of drug or alcohol abuse.
Use of any medications, including OTC and herbal or nutritional supplements during the week prior to drug dosing
Positive tests for HIV, hepatitis B/C, drugs of abuse or alcohol breath-test.
Clinically significant abnormalities

Study & Design

• Study Type: Interventional
• Study Design: Not specified