A Study of RG7667 in Healthy Volunteers
This study has been completed.
Sponsor:
Genentech
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01496755
First received: December 19, 2011
Last updated: April 1, 2013
Last verified: April 2013
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Purpose
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 | 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: | February 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
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: | April 1, 2013 |
| Health Authority: | United States: Food and Drug Administration |
ClinicalTrials.gov processed this record on May 21, 2013