A Single and Multiple Daily Injection Study of DUR-928 in Healthy Volunteers.

Phase 1

Completed

• Conditions: Acute Kidney Injury (AKI); Other Types of Acute Organ Injury; Renal and Urogenital - Kidney disease

• Registration Number: ACTRN12615000903583
• Lead Sponsor: INC Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-08-28
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Be in good health as determined by medical history, physical examination, 12 lead ECG and clinical laboratory evaluations at screening;
-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 4 days if enrolled in Part A, or 7 nights and 8 days if enrolled in Part B;
-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