A Study of RG7667 in Healthy Volunteers

NCT01496755 | Completed Phase 1

• 1 other identifier: GV28012
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 5

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

Outcome Measures

Primary Outcomes (1)

• Safety: Incidence of adverse events

  up to 141 days

Secondary Outcomes (5)

• Pharmacokinetics: Area under the concentration-time curve (AUC)

  up to 141 days

• Pharmacokinetic: Maximum serum concentration (Cmax)

  up to 141 days

• Pharmacokinetic: Time to maximum serum concentration (tmax)

  up to 141 days

• Pharmacokinetic: Apparent clearance (CL/F)

  up to 141 days

• Pharmacokinetic: Terminal half-life (t½)

  up to 141 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

RG7667

EXPERIMENTAL

Drug: RG7667

Interventions

Placebo DRUG

Single/multiple doses

Placebo

RG7667 DRUG

Single/multiple ascending doses

RG7667

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (5)

Unknown Facility

Daytona Beach, Florida, 32117, United States

Location

Unknown Facility

Honolulu, Hawaii, 96813, United States

Location

Unknown Facility

Evansville, Indiana, 47710, United States

Location

Unknown Facility

Dallas, Texas, 75247, United States

Location

Unknown Facility

Madison, Wisconsin, 53704, United States

Location

Related Publications (1)

• 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.

  PMID: 26055360 DERIVED

MeSH Terms

Interventions

RG7667

Study Officials

• Clinical Trials

  Genentech, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2011
• First Posted: December 21, 2011
• Study Start: January 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

US (5)