A study to find out if a new medicine, GDC-0214, is safe in healthy people and in patients with asthma

A Phase 1 study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of inhaled GDC-0214 conducted in three parts: a single-ascending dose study in healthy volunteers, a multiple-ascending dose study in healthy volunteers, and a proof-of-activity study in patients with mild asthma.

  • Healthy Volunteers
  • Asthma
Trial Status:

Completed

This trial runs in
Countries
  • New Zealand
Trial Identifier:

      Show trial locations

      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

      Results Disclaimer

      Trial Summary

      Healthy volunteers for Parts A (n=34) and B (n=32), and asthma patients for Part C (n=36) were enrolled at 2 study sites in New Zealand to evaluate the safety and tolerability of GDC-0214, a small molecule inhibitor of JAK1. All 102 participants completed the study and comprised the safety-evaluable population. Part A was a single-ascending dose study (0.15-15 mg of GDC-0214). Parts B and C were multiple-ascending dose studies (1-10 mg QD and 15 mg BID for Part B; 1-15 mg QD and 15 mg BID for Part C). Results showed GDC-0214 to be similarly tolerated in active and placebo dose groups in Parts A-C at doses of up to 15 mg BID; all adverse events (AEs) that occurred in ≥2 participants were all of grades 1-2. There were no deaths or serious AEs, and no discontinuations or modifications of the study treatment. The observed safety, pharmacokinetics, and pharmacodynamics data support continued development of GDC-0214 in asthma indication.

      Genentech, Inc. Sponsor
      Phase 1 Phase
      All Gender
      ≥18 years
 Age
      Yes Healthy Volunteers

      GDC-0214 is a new medicine intended for the treatment of patients with “Type 2 asthma”. This study investigated the effects of GDC-0214 when taken by healthy people and patients with mild asthma. Some participants got the study medicine while others got a placebo (no medicine) to compare side effects of the treatment with and without the medicine.

      Trial Summary

      Healthy volunteers for Parts A (n=34) and B (n=32), and asthma patients for Part C (n=36) were enrolled at 2 study sites in New Zealand to evaluate the safety and tolerability of GDC-0214, a small molecule inhibitor of JAK1. All 102 participants completed the study and comprised the safety-evaluable population. Part A was a single-ascending dose study (0.15-15 mg of GDC-0214). Parts B and C were multiple-ascending dose studies (1-10 mg QD and 15 mg BID for Part B; 1-15 mg QD and 15 mg BID for Part C). Results showed GDC-0214 to be similarly tolerated in active and placebo dose groups in Parts A-C at doses of up to 15 mg BID; all adverse events (AEs) that occurred in ≥2 participants were all of grades 1-2. There were no deaths or serious AEs, and no discontinuations or modifications of the study treatment. The observed safety, pharmacokinetics, and pharmacodynamics data support continued development of GDC-0214 in asthma indication.

      Genentech, Inc. Sponsor
      Phase 1 Phase
      GDC-0214 Treatments
      None for healthy volunteers
 Patients with asthma Condition
      Official Title

      A Phase 1 study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of inhaled GDC-0214 conducted in three parts: a single-ascending dose study in healthy volunteers, a multiple-ascending dose study in healthy volunteers, and a proof-of-activity study in patients with mild asthma.

      Eligibility Criteria

      All Gender
      ≥18 years
 Age
      Yes Healthy Volunteers

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