Compare Bioavailability of RO7239361 After Subcutaneous Injection
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ClinicalTrials.gov Identifier: NCT03100630 |
Recruitment Status :
Completed
First Posted : April 4, 2017
Last Update Posted : August 7, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Drug: RO7239361 | Phase 1 |
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 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Treatment A: RO7239361
RO7239361 subcutaneous injections on specified days; abdomen
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Drug: RO7239361
Specified dose on specified days |
Active Comparator: Treatment B: RO7239361
RO7239361 subcutaneous injections on specified days; arm
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Drug: RO7239361
Specified dose on specified days |
Active Comparator: Treatment C: RO7239361
RO7239361 subcutaneous injections on specified days; thigh
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Drug: RO7239361
Specified dose on specified days |
- Maximum observed serum concentration (Cmax) [ Time Frame: Up to 92 days ]
- AUC from time zero to time of last quantifiable concentration [AUC(0-T)] [ Time Frame: Up to 92 days ]
- AUC from time zero extrapolated to infinite time [AUC(INF)] [ Time Frame: Up to 92 days ]
- Incidence of Adverse Events ( AEs) [ Time Frame: Up to 92 days ]
- Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 92 days ]
- Change from baseline in electrocardiogram findings [ Time Frame: Up to 92 days ]
- Change from baseline in physical examination findings [ Time Frame: Up to 92 days ]
- Change from baseline in clinical laboratory test findings [ Time Frame: Up to 92 days ]

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03100630
United States, California | |
WCCT Global, Inc. | |
Cypress, California, United States, 90630 |
Study Director: | Clinical Trials | Hoffmann-La Roche |
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 Key Record Dates |
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 |