A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of DUR 928 Administered Intramuscularly (IM) in Healthy Volunteers

INC Research0 个研究点目标入组 44 人开始时间: 2015年8月28日最近更新: 2020年1月13日

试验速览

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•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.

•-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

发起方

INC Research