A Study of RG7667 in Healthy Volunteers

• Register: ClinicalTrials.gov
• Last refreshed on: 8 April 2013
• Main ID: NCT01496755
• Date of registration: 19/12/2011
• Primary sponsor: Genentech
• Public title: A Study of RG7667 in Healthy Volunteers
• Scientific title: A Phase I Randomized, Double-Blind, Placebo-Controlled Trial of Single and Multiple Doses of RG7667 in Healthy Adult Volunteers
• Date of first enrolment: January 2012
• Target sample size: 170
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01496755
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Countries of recruitment

United States

Contacts

• Name: Clinical Trials
• Affiliation: Genentech

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy Volunteer

Intervention(s)

Drug: Placebo

Drug: RG7667

Primary Outcome(s)

Safety: Incidence of adverse events [Time Frame: up to 141 days]

Secondary Outcome(s)

Pharmacokinetic: Apparent clearance (CL/F) [Time Frame: up to 141 days]

Pharmacokinetic: Maximum serum concentration (Cmax) [Time Frame: up to 141 days]

Pharmacokinetic: Terminal half-life (t½) [Time Frame: up to 141 days]

Pharmacokinetic: Time to maximum serum concentration (tmax) [Time Frame: up to 141 days]

Pharmacokinetics: Area under the concentration-time curve (AUC) [Time Frame: up to 141 days]

Secondary ID(s)

GV28012

Source(s) of Monetary Support

Please refer to primary and secondary sponsors