Compare Bioavailability of RO7239361 After Subcutaneous Injection

An Open-label, Randomized, Parallel-group, Single Dose Study to Compare the Bioavailability of Subcutaneous Injections in the Arm, Thigh, and Abdomen and to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of RO7239361 in Healthy Participants

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: RO7239361

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Cypress, California, United States, 90630
      • WCCT Global, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Other protocol defined inclusion and exclusion criteria apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Treatment A: RO7239361; RO7239361 subcutaneous injections on specified days; abdomen	Drug: RO7239361; Specified dose on specified days
ACTIVE_COMPARATOR: Treatment B: RO7239361; RO7239361 subcutaneous injections on specified days; arm	Drug: RO7239361; Specified dose on specified days
ACTIVE_COMPARATOR: Treatment C: RO7239361; RO7239361 subcutaneous injections on specified days; thigh	Drug: RO7239361; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum observed serum concentration (Cmax)	Up to 92 days
AUC from time zero to time of last quantifiable concentration [AUC(0-T)]	Up to 92 days
AUC from time zero extrapolated to infinite time [AUC(INF)]	Up to 92 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of Adverse Events ( AEs)	Up to 92 days
Incidence of Serious Adverse Events (SAEs)	Up to 92 days
Change from baseline in electrocardiogram findings	Up to 92 days
Change from baseline in physical examination findings	Up to 92 days
Change from baseline in clinical laboratory test findings	Up to 92 days

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Publications and helpful links

Helpful Links

• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 9, 2017
• Primary Completion (ACTUAL): October 17, 2017
• Study Completion (ACTUAL): October 17, 2017

Study Registration Dates

• First Submitted: March 29, 2017
• First Submitted That Met QC Criteria: March 29, 2017
• First Posted (ACTUAL): April 4, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 7, 2019
• Last Update Submitted That Met QC Criteria: August 5, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: CN001-023; WP40225 (OTHER: Hoffman LaRoche Protocol ID)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No