A study to look at how safe different doses of a new study medicine (RO7303509) were for healthy people to take – and how this medicine was processed through the body

  • Healthy Volunteers
Please note that the recruitment status of the study at your site may differ from the overall study status because some study sites may recruit earlier than others.
Study Status:

Completed

This study runs in
Country
  • United States
Study Identifier:

GA42285

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      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      Study Summary

      This clinical trial investigated a new medicine called, “RO7303509”, for the treatment of “systemic sclerosis”. This study was done to find out how safe it was for healthy people to get a single treatment of this study medicine. Different groups of people were given different doses of RO7303509. This was a phase 1a, randomized, double‑blind, placebo-controlled, single ascending-dose study in healthy volunteers.

      Genentech, Inc. (A part of F. Hoffmann-La Roche Ltd., Switzerland) Sponsor
      Phase 1a Phase
      GA42285 Study Identifier
      Both Gender
      18 to 75 Years Age
      Yes Healthy Volunteers

      Healthy volunteers were enrolled at one study site in USA to evaluate the safety and tolerability of RO7303509, a treatment for systemic sclerosis. Forty-nine participants contributed to the final analyses of the safety data in this phase 1a, randomized, double‑blind, placebo-controlled, single ascending-dose study. Results showed RO7303509 to be well tolerated; there were some low-grade common side effects, but no deaths, no serious side effects, or side effects leading to study discontinuations.

      Study Summary

      This clinical trial investigated a new medicine called, “RO7303509”, for the treatment of “systemic sclerosis”. This study was done to find out how safe it was for healthy people to get a single treatment of this study medicine. Different groups of people were given different doses of RO7303509. This was a phase 1a, randomized, double‑blind, placebo-controlled, single ascending-dose study in healthy volunteers.

      Genentech, Inc. (A part of F. Hoffmann-La Roche Ltd., Switzerland) Sponsor
      Phase 1a Phase
      GA42285 Study Identifier
      RO7303509 Treatments
      Healthy volunteers Condition
      Official Title

      A phase 1a, randomized, double‑blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of single ascending doses of RO7303509 in healthy volunteers

      Eligibility Criteria

      Both Gender
      18 to 75 Years Age
      Yes Healthy Volunteers

      For the latest version of this information please go to www.forpatients.roche.com

       

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