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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
- Respiratory Disorder
- Asthma
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
Country
- New Zealand
Trial Identifier:
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
For the latest version of this information please go to www.forpatients.roche.com