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OpenTrials
Completed

NCT Number: NCT03100630

Compare Bioavailability of RO7239361 After Subcutaneous Injection

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

WCCT Global, Inc.

Cypress, California, 90630, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RO7239361

Drug

Specified dose on specified days

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 4, 2017
Registry last updated
Aug 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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