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Compare Bioavailability of RO7239361 After Subcutaneous Injection

NCT ID: NCT03100630

Last Updated: 2019-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-09

Study Completion Date

2017-10-17

Brief Summary

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Randomized study in healthy men and women. Assess the similarity of RO7239361 when injected into the arm, thigh, or the stomach. Collect data on safety of RO7239361.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Treatment A: RO7239361

RO7239361 subcutaneous injections on specified days; abdomen

Group Type ACTIVE_COMPARATOR

RO7239361

Intervention Type DRUG

Specified dose on specified days

Treatment B: RO7239361

RO7239361 subcutaneous injections on specified days; arm

Group Type ACTIVE_COMPARATOR

RO7239361

Intervention Type DRUG

Specified dose on specified days

Treatment C: RO7239361

RO7239361 subcutaneous injections on specified days; thigh

Group Type ACTIVE_COMPARATOR

RO7239361

Intervention Type DRUG

Specified dose on specified days

Interventions

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RO7239361

Specified dose on specified days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy participant as determined by no significant deviations in normal medical and surgical history and assessments
* Body Mass Index 18 kg/m2 to 32 kg/m2
* females must be of non-childbearing potential

Exclusion Criteria

* tattoos or other skin findings on any of the potential injection sites
* history of chronic muscle pain within 30 days prior to study treatment
* prior history of IgG1 therapy
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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WCCT Global, Inc.

Cypress, California, United States

Site Status

Countries

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United States

Related Links

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http://www.bms.com/clinical_trials/pages/investigator_inquiry_form.aspx

Investigator Inquiry Form

http://www.fda.gov/Safety/Recalls/

FDA Safety Alerts and Recalls

Other Identifiers

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WP40225

Identifier Type: OTHER

Identifier Source: secondary_id

CN001-023

Identifier Type: -

Identifier Source: org_study_id

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