Phase 1A Safety Trial of Inhaled PK10571 (GB002)

Completed · Phase 1 · Has a placebo group

Conditions studied: Safety Issues

In brief

This is a phase 1A randomized double blind placebo controlled single ascending dose and multiple ascending dose trial of inhaled PK10571 (GB002) in healthy adult subjects.

Key facts

Study ID

NCT03473236

Run by

GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.

People needed

66

Starts

2017-09-06

Expected to finish

2018-12-03

Last updated by the study team

2020-06-09

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Males and females (if unable to become pregnant)
• Age 18-55
• Body mass index (BMI) 18-32 kg/m\^2 and minimum weight of 50 kg (110 lbs)
• Non-smoker
• Ability to give informed consent
• Ability to remain in study unit for duration of study and return for outpatient visits
• Ability to use dry powder inhaler (DPI) effectively
• (See full protocol for additional details.)

You may not qualify if…

• Hospitalization within the 6 months prior to the first dose of study treatment
• History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the subject or the validity of the study results
• History or presence of active lung disease (i.e., asthma, chronic obstructive pulmonary disease [COPD], pulmonary fibrosis, hemoptysis, bronchiectasis) or prior intubation
• Currently uses an inhaler
• History or presence of heart disease (i.e., prior myocardial infarction [MI], coronary artery disease, heart failure, hypertension, pulmonary hypertension, valve disease, atrial fibrillation, other arrhythmia, or prolonged QT syndrome)
• History or presence of cancer (with the exception of basal cell skin cancer that has been effectively treated)
• History of diabetes mellitus
• History of thyroid disease other than hypothyroidism control with levothyroxine and documented normal thyroid-stimulating hormone (TSH)
• History of tuberculosis, Lyme disease, or other chronic or opportunistic infection.
• History of positive purified protein derivative (PPD) skin test, or positive PPD test at screening
• Has a positive test for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) at screening or has been previously treated for hepatitis B, hepatitis C, or HIV infection
• History of smoking within the past 15 years
• Is a female with a positive pregnancy test result, or who has the ability to become pregnant, or who is lactating
• Has forced expiratory volume in 1 second (FEV1) less than 80% predicted, forced vital capacity (FVC) ˂80% predicted, or resting oxygen saturation less than 97% on room air at screening or baseline
• Upper respiratory infection within the 3 months prior to the first dose of medication
• History of major bleeding or major surgical procedure of any type within 6 months prior to the first dose of medication
• History of minor bleeding disorders such as epistaxis, rectal bleeding (spots of blood on toilet paper), and gingival bleeding within 3 months before the study treatment
• History of bleeding disorder or coagulopathy
• Females with history of dysfunctional uterine bleeding, including history of menorrhagia or metrorrhagia, unless subject has had a hysterectomy.
• History of GI bleed
• Has used any over-the-counter (OTC) medication, nutritional or dietary supplements, herbal preparations, or vitamins within 7 days prior to the first dose of medication
• Has used any antiplatelet agents such as acetylsalicylic acid (ASA), nonsteroidal anti-inflammatory drugs (NSAIDs), clopidogrel (or similar agent) or anti-coagulants within 7 days prior to the first dose of medication
• Has used any prescription medication, except female hormonal replacement therapy, within 14 days prior to the first dose of study medication
• Has been treated with any known drugs that are moderate or strong inhibitors/inducers of CYP enzymes such as barbiturates, phenothiazines, cimetidine, carbamazepine, etc., within 30 days prior to the first dose of study medication and that in the Investigator's judgment may impact subject safety or the validity of the study results
• History of peripheral vascular disease

Where it is running

• Phase 1 Unit — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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