A Study of RG7667 in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01496755
First received: December 19, 2011
Last updated: September 2, 2014
Last verified: September 2014
  Purpose

This randomized, double-blind, placebo-controlled study will evaluate the safety and pharmacokinetics of RG7667 in healthy volunteers. Subjects will be randomiz ed 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 fo llow-up.


Condition Intervention Phase
Healthy Volunteer
Drug: RG7667
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: A Phase I Randomized, Double-Blind, Placebo-Controlled Trial of Single and Multiple Doses of RG7667 in Healthy Adult Volunteers

Further study details as provided by Genentech:

Primary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: up to 141 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetics: Area under the concentration-time curve (AUC) [ Time Frame: up to 141 days ] [ Designated as safety issue: No ]
  • Pharmacokinetic: Maximum serum concentration (Cmax) [ Time Frame: up to 141 days ] [ Designated as safety issue: No ]
  • Pharmacokinetic: Time to maximum serum concentration (tmax) [ Time Frame: up to 141 days ] [ Designated as safety issue: No ]
  • Pharmacokinetic: Apparent clearance (CL/F) [ Time Frame: up to 141 days ] [ Designated as safety issue: No ]
  • Pharmacokinetic: Terminal half-life (t½) [ Time Frame: up to 141 days ] [ Designated as safety issue: No ]

Enrollment: 170
Study Start Date: January 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RG7667 Drug: RG7667
Single/multiple ascending doses
Placebo Comparator: Placebo Drug: Placebo
Single/multiple doses

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01496755

Locations
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
Investigators
Study Director: Clinical Trials Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01496755     History of Changes
Other Study ID Numbers: GV28012
Study First Received: December 19, 2011
Last Updated: September 2, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on September 16, 2014