A Study of RG7667 in Healthy Volunteers



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 55
Updated:8/3/2016
Start Date:January 2012
End Date:January 2013

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A Phase I Randomized, Double-Blind, Placebo-Controlled Trial of Single and Multiple Doses of RG7667 in Healthy Adult Volunteers

This randomized, double-blind, placebo-controlled study will evaluate the safety and
pharmacokinetics of RG7667 in healthy volunteers. Subjects will be randomized in cohorts to
receive either single/multiple doses of RG7667 intravenously or placebo. Anticipated time on
study treatment is up to 57 days with a 12-week follow-up.


Inclusion Criteria:

- Male and female subjects, 18 to 55 years of age, inclusive

- Body mass index 18.0 to 31.0 kg/m2, inclusive

- In good health, determined by no clinically significant findings from medical
history, 12-lead ECG, vital signs, and laboratory values, as deemed by the
Investigator

Exclusion Criteria:

- History of malignancy, except completely excised basal cell carcinoma or squamous
cell carcinoma of the skin or cervical carcinoma in situ

- History of severe bacterial, fungal, or parasitic infections (more than 2
hospitalizations within 1 year or more than 2 courses of iv antibiotics within 1
year)

- Pregnant, lactating, or planned pregnancy within 6 months of Screening

- Positive for hepatitis B, hepatitis C or HIV infection

- Exposure to any investigational biological agent within 90 days prior to the
Screening evaluation or received any other investigational treatment 30 days prior to
the Screening evaluation (or within 5 half-lives of the investigational agent,
whichever is greater)

- History of alcoholism or drug addiction within 1 year of Screening

- Positive urine test for selected drugs of abuse at Screening and Check-in (Day -1);
positive breathalyzer test for alcohol at Check-in

- Use of prescription drugs within 14 days prior to Day 1 or during the study, except
for hormonal contraceptives or hormone replacement therapy

- Use of over-the-counter (OTC) medication within 7 days prior to Day 1 or during the
study. Medications such as acetaminophen and ibuprofen and routinely-taken dietary
supplements, including vitamins and herbal supplements are allowed at the discretion
of the investigator and Sponsor.

- Donation of plasma within 7 days prior to Day 1. Donation or loss of blood of 50 mL
to 499 mL of blood within 30 days, or more than 499 mL within 56 days prior to Day 1.

- Lack of peripheral venous access
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