A Study of RG7667 in Healthy Volunteers

NCT ID: NCT01496755

Last Updated: 2016-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2013-01-31

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.

Conditions

Healthy Volunteer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Single/multiple doses

RG7667

Group Type: EXPERIMENTAL

RG7667

Intervention Type: DRUG

Single/multiple ascending doses

Interventions

Placebo

Single/multiple doses

Intervention Type: DRUG

RG7667

Single/multiple ascending doses

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Genentech, Inc.

Locations

Daytona Beach, Florida, United States

Honolulu, Hawaii, United States

Evansville, Indiana, United States

Dallas, Texas, United States

Madison, Wisconsin, United States

Countries

United States

References

Ishida JH, Burgess T, Derby MA, Brown PA, Maia M, Deng R, Emu B, Feierbach B, Fouts AE, Liao XC, Tavel JA. Phase 1 Randomized, Double-Blind, Placebo-Controlled Study of RG7667, an Anticytomegalovirus Combination Monoclonal Antibody Therapy, in Healthy Adults. Antimicrob Agents Chemother. 2015 Aug;59(8):4919-29. doi: 10.1128/AAC.00523-15. Epub 2015 Jun 8.

Reference Type: DERIVED

PMID: 26055360 (View on PubMed)

Other Identifiers

GV28012

Identifier Type: -

Identifier Source: org_study_id