Compare Bioavailability of RO7239361 After Subcutaneous Injection

• ClinicalTrials.gov Identifier: NCT03100630
• Recruitment Status: Completed
• First Posted: April 4, 2017
• Last Update Posted: August 7, 2019
• Sponsor: Hoffmann-La Roche
• Information provided by (Responsible Party): Hoffmann-La Roche

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Healthy	Drug: RO7239361	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 99 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: 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
• Actual Study Start Date: May 9, 2017
• Actual Primary Completion Date: October 17, 2017
• Actual Study Completion Date: October 17, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Incidence of Adverse Events ( AEs) [ Time Frame: Up to 92 days ]
2. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 92 days ]
3. Change from baseline in electrocardiogram findings [ Time Frame: Up to 92 days ]
4. Change from baseline in physical examination findings [ Time Frame: Up to 92 days ]
5. Change from baseline in clinical laboratory test findings [ Time Frame: Up to 92 days ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 55 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, California

WCCT Global, Inc.

Cypress, California, United States, 90630

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials; Hoffmann-La Roche

More Information

Additional Information:

Investigator Inquiry Form  FDA Safety Alerts and Recalls 

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT03100630
• Other Study ID Numbers: CN001-023; WP40225 ( Other Identifier: Hoffman LaRoche Protocol ID )
• First Posted: April 4, 2017
• Last Update Posted: August 7, 2019
• Last Verified: August 2019

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No