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A Study of RG7667 in Healthy Volunteers

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. Identifier: NCT01496755
Recruitment Status : Completed
First Posted : December 21, 2011
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Genentech, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: Placebo Drug: RG7667 Phase 1

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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

Primary Outcome Measures :
  1. Safety: Incidence of adverse events [ Time Frame: up to 141 days ]

Secondary Outcome Measures :
  1. Pharmacokinetics: Area under the concentration-time curve (AUC) [ Time Frame: up to 141 days ]
  2. Pharmacokinetic: Maximum serum concentration (Cmax) [ Time Frame: up to 141 days ]
  3. Pharmacokinetic: Time to maximum serum concentration (tmax) [ Time Frame: up to 141 days ]
  4. Pharmacokinetic: Apparent clearance (CL/F) [ Time Frame: up to 141 days ]
  5. Pharmacokinetic: Terminal half-life (t½) [ Time Frame: up to 141 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01496755

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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
Sponsors and Collaborators
Genentech, Inc.
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Study Director: Clinical Trials Genentech, Inc.
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Genentech, Inc. 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