Clinical trial NCT01496755: A Study of RG7667 in Healthy Volunteers
Official title: A Phase I Randomized, Double-Blind, Placebo-Controlled Trial of Single and Multiple Doses of RG7667 in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2011-12-21
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


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

Primary outcomes:
measure: Safety: Incidence of adverse events
timeFrame: up to 141 days
Secondary outcomes:
measure: Pharmacokinetics: Area under the concentration-time curve (AUC)
timeFrame: up to 141 days
measure: Pharmacokinetic: Maximum serum concentration (Cmax)
timeFrame: up to 141 days
measure: Pharmacokinetic: Time to maximum serum concentration (tmax)
timeFrame: up to 141 days
measure: Pharmacokinetic: Apparent clearance (CL/F)
timeFrame: up to 141 days
measure: Pharmacokinetic: Terminal half-life (t½)
timeFrame: up to 141 days
Other outcomes:
Locations:
city: Daytona Beach
country: United States
state: Florida
city: Honolulu
country: United States
state: Hawaii
city: Evansville
country: United States
state: Indiana
city: Dallas
country: United States
state: Texas
city: Madison
country: United States
state: Wisconsin
Study officials:
affiliation: Genentech, Inc.
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.