RecruitingPulmonary Arterial Hypertension

Open-label Extension Study of Seralutinib in Adult Subjects With PAH (PROSERA-EXT)

Eligible age

18–75 yrs

Accepts

All genders

Locations

19 states

Healthy volunteers

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About this study

This open-label extension study will evaluate the long-term safety, tolerability and efficacy of orally inhaled seralutinib in subjects who have completed a previous seralutinib study

Sponsor: Gossamer Bio USA, Inc.

You may qualify if…

✓ 1. Subjects must have completed a qualifying last visit in a prior seralutinib PAH study on investigational product (IP) and in accordance with the protocol.
✓ 2. Evidence of an informed consent document, signed and dated by the subject, indicating that the subject has been informed of all pertinent aspects of the study prior to initiation of any subject-mandated procedures.
✓ 3. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
✓ 4. Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test at enrollment visit before first administration of Investigational Product (IP) in this study.
✓ 5. WOCBP who are not abstinent and intend to be sexually active with a non-sterilized male partner must be willing to use a highly effective method of contraception from consent through 30 days following the last administration of IP.
✓ 6. Male subjects: Non-sterilized male subjects who are not abstinent and intend to be sexually active with a female partner of childbearing potential must use a male condom from consent through 90 days after the last dose of IP.

You may not qualify if…

✕ 1. Severe acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation or seralutinib administration, unless associated with an ongoing AE and discussed with the Sponsor's medical monitor (MM) (or designee).
✕ 2. Have any other condition or reason that, in the opinion of the Investigator, would prohibit the subject from participating in the study.