A Study of RG7667 in Healthy Volunteers

Healthy Volunteer Clinical Trial

Official title:

A Phase I Randomized, Double-Blind, Placebo-Controlled Trial of Single and Multiple Doses of RG7667 in Healthy Adult Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01496755
• Other study ID #: GV28012
• Status: Completed
• Phase: Phase 1
• First received: December 19, 2011
• Last updated: November 1, 2016
• Start date: January 2012
• Est. completion date: January 2013

Study information

• Verified date: November 2016
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• Placebo
Single/multiple doses
• RG7667
Single/multiple ascending doses

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: Incidence of adverse events		up to 141 days	No
Secondary	Pharmacokinetics: Area under the concentration-time curve (AUC)		up to 141 days	No
Secondary	Pharmacokinetic: Maximum serum concentration (Cmax)		up to 141 days	No
Secondary	Pharmacokinetic: Time to maximum serum concentration (tmax)		up to 141 days	No
Secondary	Pharmacokinetic: Apparent clearance (CL/F)		up to 141 days	No
Secondary	Pharmacokinetic: Terminal half-life (t½)		up to 141 days	No