ACTRN12619000227190
Completed
Phase 1
A Phase I study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of inhaled gdc-4379 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
- Enrollment
- 128
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
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 malignancy, except completely excised basal cell carcinoma or squamous cell carcinoma of the skin
- •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
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Phase 1
Inhalation of Leukotriene B4 (LTB4) in patients suffering from BronchiectasisACTRN12614001199606TB4 Sweden AB30
Completed
Phase 1
Phase I trial to evaluate the safety and tolerability of GDC-0214 in healthy volunteers and patients with mild asthmaAsthmaRespiratory - AsthmaACTRN12617001227381Genentech, Inc.102
Completed
N/A
A phase I study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple-dose subcutaneous and intravenous administration of OMS721 in healthy subjectsautoimmune diseases10003816NL-OMON42466Omeros Corporation24
Completed
N/A
A phase 1 study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of OMS1029 with single-dose intravenous and subcutaneous administration in healthy subjectsNL-OMON53550Omeros Corporation48
Completed
N/A
GEN-001 single dose phase 1 studyNot ApplicableKCT0005339Chonbuk National University Hospital20