ACTRN12617001227381
Completed
Phase 1
A Phase I study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of 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.
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Asthma
- Sponsor
- Genentech, Inc.
- Enrollment
- 102
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Key Inclusion Criteria for Healthy Volunteers • Signed Informed Consent Form
- •Age 18\-65 years
- •Body mass index of 18\-37 kg/m2
- •Weight of 50\-120 kg
- •In good health, determined by no clinically significant findings from medical history, 12\-lead ECG, and vital signs.
- •First forced expiratory volume (FEV1\) \>70 % predicted
- •Forced vital capacity (FVC) \>2\.0 L
- •Ability to demonstrate sufficient inspiratory effort using the inhaler training
- •Ability to comply with the study protocol, including all study procedures
- •Agreement to remain abstinent or use contraceptive methods
Exclusion Criteria
- •Key Exclusion Criteria for Healthy Volunteers
- •Subjects who meet any of the following criteria will be excluded from Parts A and B:
- •History or clinical manifestations of significant metabolic, hepatic, renal, pulmonary, cardiovascular, gastrointestinal, urologic, neurologic, or psychiatric disorders, in the investigator’s judgment
- •History of nasal polyposis or nasal polyps identified during screening physical examination
- •History of anaphylaxis, hypersensitivity, or significant drug allergies
- •History of severe hypersensitivity to milk proteins
- •History or presence of an abnormal ECG that is clinically significant
- •Any medical condition or abnormality in clinical laboratory tests that, in the investigator’s judgment, precludes the subject’s safe participation in and completion of the study
- •Illicit drug or alcohol abuse within 12 months prior to initiation of study drug
- •Positive alcohol screen at screening or pre\-randomization
Outcomes
Primary Outcomes
Not specified
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