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OpenTrials
Completed

NCT Number: NCT01496755

A Study of RG7667 in Healthy Volunteers

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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Daytona Beach, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Single/multiple doses

RG7667

Drug

Single/multiple ascending doses

Primary outcomes

  1. Safety: Incidence of adverse events

    Time frame: up to 141 days

Secondary outcomes

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

    Time frame: up to 141 days

  2. Pharmacokinetic: Maximum serum concentration (Cmax)

    Time frame: up to 141 days

  3. Pharmacokinetic: Time to maximum serum concentration (tmax)

    Time frame: up to 141 days

  4. Pharmacokinetic: Apparent clearance (CL/F)

    Time frame: up to 141 days

  5. Pharmacokinetic: Terminal half-life (t½)

    Time frame: up to 141 days

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 21, 2011
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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