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Completed

NCT Number: NCT02427243

A Study in Healthy Volunteers to Assess the Relative Bioavailability and Tolerability of Two Crenezumab Formulations Following Administration of a Single Subcutaneous Dose

To assess the relative bioavailability and tolerability of two different formulations of crenezumab in approximately 60 healthy volunteers.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Evansville, Indiana, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male or female 18 to 65 years of age at Screening, inclusive
  • Body mass index (BMI) 18.5 to 32 kg/m^2, inclusive
  • Body weight 50 to 100 kg, inclusive
  • Females must be of non-childbearing potential
  • Males of reproductive potential must agree to remain abstinent or must be using highly effective contraception and must avoid sperm donation, from Screening until at least 8 weeks after the last study drug administration or until study completion, whichever is later

Exclusion criteria

  • Significant medical history, psychiatric disorder, or acute infection at Screening (as determined by Investigator)
  • History of alcoholism or drug addiction within 6 months prior to CRU Check-in
  • Use of tobacco or nicotine-containing products from 6 months prior to CRU Check-in and during the study
  • Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred wtihin 30 days or 5 half-lives, whichever is longer, prior to CRU Check-in

Treatment and study plan

Crenezumab

Drug

Other names: RO5490245 or MABT5102A (formerly)

Primary outcomes

  1. Pharmacokinetic (PK) profile of crenezumab (Cmax, tmax, AUC0-last, AUC(0-infinity), Vz/F, CL/F, Apparent terminal elimination rate constant, and t1/2)

    Time frame: Day 1 through Day 85 or early termination

Secondary outcomes

  1. Incidence, nature, and severity of adverse events

    Time frame: Consent through Day 85 or early termination

  2. Incidence of anti-therapeutic antibodies (ATAs) to crenezumab

    Time frame: From Day 1 (Predose) through Day 85 or early termination

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study title

A Phase 1, Single-Dose, Randomized, Open-Label, Parallel Group Study to Assess the Relative Bioavailability and Tolerability of Two Formulations of Crenezumab in Healthy Subjects Following Subcutaneous Administration

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Apr 27, 2015
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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