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

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

Official Title
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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

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: Crenezumab
* Drug: Crenezumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Crenezumab Formulation 2<br>A single dose given as two subcutaneous injections on Day 1 | Drug: Crenezumab<br> <br> * Other names: RO5490245 or MABT5102A (formerly);|
| Experimental: Crenezumab Formulation 3<br>A single dose given as two subcutaneous injections on Day 1 | Drug: Crenezumab<br> <br> * Other names: RO5490245 or MABT5102A (formerly);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |