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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
- Asthma
Trial Status:
Completed
This trial runs in
Cities
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