A study to look at how safe different doses of a new medicine called MTPS9579A were for healthy people to take, and how this medicine was processed through the body

A phase 1, single center, randomized, observer-blinded, placebo-controlled study to evaluated the safety, tolerability, pharmacokinetics, and explore pharmacodynamics effects and immunogenicity of single- and multiple-ascending doses of MTPS9579A in healthy adult subjects

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

Completed

This trial runs in
N/A
Trial Identifier:

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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 trial 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.

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      Trial Summary

      One hundred and six healthy male (n=36) and female (n=70) subjects, between 18-55 years of age, enrolled at a single site in Canada. Some participants (n=42) received a single subcutaneous dose (30, 100, or 300 mg MTPS9579A or placebo). Others (n=40) received 3 doses given once every 4 weeks (5 cohorts, including 150, 300, and 750 mg dose cohorts [subcutaneous MTPS9579A or placebo]; 1800 and 3600 mg dose cohorts [IV infusion MTPS9579A or placebo]). Adverse events (rate and severity) were comparable across the dose-level cohorts, between subjects who received MTPS9579A or placebo; the majority were Grade 1 in severity and judged as not related to the study drug. There were no serious adverse events and no deaths. No safety concerns with respect to the clinical laboratory tests, ECGs, and vital signs were noted.

      Genentech Sponsor
      Phase 1 Phase
      All Gender
      ≥18 Years Age
      Yes Healthy Volunteers

      MTPS9579A is a new medicine intended for the treatment of patients with severe asthma. This study investigated the effects of MTPS9579A when taken by healthy people. Some people got the study medicine while others got a placebo (no medicine) to compare side effects of the treatment with and without the medicine. There were 106 healthy people who took part in this study conducted in Canada.

      Trial Summary

      One hundred and six healthy male (n=36) and female (n=70) subjects, between 18-55 years of age, enrolled at a single site in Canada. Some participants (n=42) received a single subcutaneous dose (30, 100, or 300 mg MTPS9579A or placebo). Others (n=40) received 3 doses given once every 4 weeks (5 cohorts, including 150, 300, and 750 mg dose cohorts [subcutaneous MTPS9579A or placebo]; 1800 and 3600 mg dose cohorts [IV infusion MTPS9579A or placebo]). Adverse events (rate and severity) were comparable across the dose-level cohorts, between subjects who received MTPS9579A or placebo; the majority were Grade 1 in severity and judged as not related to the study drug. There were no serious adverse events and no deaths. No safety concerns with respect to the clinical laboratory tests, ECGs, and vital signs were noted.

      Genentech Sponsor
      Phase 1 Phase
      MTPS9579A Treatments
      None Condition
      Official Title

      A phase 1, single center, randomized, observer-blinded, placebo-controlled study to evaluated the safety, tolerability, pharmacokinetics, and explore pharmacodynamics effects and immunogenicity of single- and multiple-ascending doses of MTPS9579A in healthy adult subjects.

      Eligibility Criteria

      All Gender
      ≥18 Years Age
      Yes Healthy Volunteers

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

       

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