Compare Bioavailability of RO7239361 After Subcutaneous Injection

• Sponsor: Hoffmann-La Roche (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03100630
• Collaborator: (none)
• Enrollment: 99
• Location: 1
• Arms: 3
• Actual Duration (Months): 5.3
• Patients Per Site Per Month: 18.7

Study Details

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
• 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: Oct 17, 2017
• Actual Study Completion Date: Oct 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) [Up to 92 days]

2. AUC from time zero to time of last quantifiable concentration [AUC(0-T)] [Up to 92 days]

3. AUC from time zero extrapolated to infinite time [AUC(INF)] [Up to 92 days]

Secondary Outcome Measures

1. Incidence of Adverse Events ( AEs) [Up to 92 days]

2. Incidence of Serious Adverse Events (SAEs) [Up to 92 days]

3. Change from baseline in electrocardiogram findings [Up to 92 days]

4. Change from baseline in physical examination findings [Up to 92 days]

5. Change from baseline in clinical laboratory test findings [Up to 92 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	WCCT Global, Inc.	Cypress	California	United States	90630

Sponsors and Collaborators

• Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• FDA Safety Alerts and Recalls

Publications

None provided.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT03100630
• Other Study ID Numbers: CN001-023; WP40225
• First Posted: Apr 4, 2017
• Last Update Posted: Aug 7, 2019
• Last Verified: Aug 1, 2019

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

Study Results

No Results Posted as of Aug 7, 2019