A Study of RG7667 in Healthy Volunteers
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01496755 |
Recruitment Status :
Completed
First Posted : December 21, 2011
Last Update Posted : November 2, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy Volunteer | Drug: Placebo Drug: RG7667 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 170 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Official Title: | A Phase I Randomized, Double-Blind, Placebo-Controlled Trial of Single and Multiple Doses of RG7667 in Healthy Adult Volunteers |
Study Start Date : | January 2012 |
Actual Primary Completion Date : | January 2013 |
Actual Study Completion Date : | January 2013 |
Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo |
Drug: Placebo
Single/multiple doses |
Experimental: RG7667 |
Drug: RG7667
Single/multiple ascending doses |
- Safety: Incidence of adverse events [ Time Frame: up to 141 days ]
- Pharmacokinetics: Area under the concentration-time curve (AUC) [ Time Frame: up to 141 days ]
- Pharmacokinetic: Maximum serum concentration (Cmax) [ Time Frame: up to 141 days ]
- Pharmacokinetic: Time to maximum serum concentration (tmax) [ Time Frame: up to 141 days ]
- Pharmacokinetic: Apparent clearance (CL/F) [ Time Frame: up to 141 days ]
- Pharmacokinetic: Terminal half-life (t½) [ Time Frame: up to 141 days ]

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01496755
United States, Florida | |
Daytona Beach, Florida, United States, 32117 | |
United States, Hawaii | |
Honolulu, Hawaii, United States, 96813 | |
United States, Indiana | |
Evansville, Indiana, United States, 47710 | |
United States, Texas | |
Dallas, Texas, United States, 75247 | |
United States, Wisconsin | |
Madison, Wisconsin, United States, 53704 |
Study Director: | Clinical Trials | Genentech, Inc. |
Responsible Party: | Genentech, Inc. |
ClinicalTrials.gov Identifier: | NCT01496755 |
Other Study ID Numbers: |
GV28012 |
First Posted: | December 21, 2011 Key Record Dates |
Last Update Posted: | November 2, 2016 |
Last Verified: | November 2016 |