A Study in Healthy Volunteers to Assess the Relative Bioavailability and Tolerability of Two Crenezumab Formulations Following Administration of a Single Subcutaneous Dose
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
1 other identifier
interventional
60
1 country
2
Brief Summary
To assess the relative bioavailability and tolerability of two different formulations of crenezumab in approximately 60 healthy volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2015
Shorter than P25 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 22, 2015
CompletedFirst Posted
Study publicly available on registry
April 27, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedNovember 2, 2016
November 1, 2016
3 months
April 22, 2015
November 1, 2016
Conditions
Outcome Measures
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)
Day 1 through Day 85 or early termination
Secondary Outcomes (2)
Incidence, nature, and severity of adverse events
Consent through Day 85 or early termination
Incidence of anti-therapeutic antibodies (ATAs) to crenezumab
From Day 1 (Predose) through Day 85 or early termination
Study Arms (2)
Crenezumab Formulation 2
EXPERIMENTALA single dose given as two subcutaneous injections on Day 1
Crenezumab Formulation 3
EXPERIMENTALA single dose given as two subcutaneous injections on Day 1
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genentech, Inc.lead
Study Sites (2)
Unknown Facility
Evansville, Indiana, 47710, United States
Unknown Facility
Dallas, Texas, 75247, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2015
First Posted
April 27, 2015
Study Start
April 1, 2015
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
November 2, 2016
Record last verified: 2016-11