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Compare Bioavailability of RO7239361 After Subcutaneous Injection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03100630
Recruitment Status : Completed
First Posted : April 4, 2017
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE March 29, 2017
First Posted Date  ICMJE April 4, 2017
Last Update Posted Date August 7, 2019
Actual Study Start Date  ICMJE May 9, 2017
Actual Primary Completion Date October 17, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 29, 2017)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 29, 2017)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Compare Bioavailability of RO7239361 After Subcutaneous Injection
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Healthy
Intervention  ICMJE Drug: RO7239361
Specified dose on specified days
Study Arms  ICMJE
  • Active Comparator: Treatment A: RO7239361
    RO7239361 subcutaneous injections on specified days; abdomen
    Intervention: Drug: RO7239361
  • Active Comparator: Treatment B: RO7239361
    RO7239361 subcutaneous injections on specified days; arm
    Intervention: Drug: RO7239361
  • Active Comparator: Treatment C: RO7239361
    RO7239361 subcutaneous injections on specified days; thigh
    Intervention: Drug: RO7239361
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 29, 2018)
99
Original Estimated Enrollment  ICMJE
 (submitted: March 29, 2017)
75
Actual Study Completion Date  ICMJE October 17, 2017
Actual Primary Completion Date October 17, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03100630
Other Study ID Numbers  ICMJE CN001-023
WP40225 ( Other Identifier: Hoffman LaRoche Protocol ID )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP