Ensayos clínicos

Inclusion Criteria:

- Taken part in either of the prior PRM-151 studies: PRM-151-202 or WA42293.

- For women of childbearing potential: agreement to remain abstinent (refrain from
heterosexual intercourse) or use contraception.

- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use
a condom, and agreement to refrain from donating sperm.

Exclusion Criteria:

- Acute respiratory or systemic bacterial, viral, or fungal infection at the first visit
of the OLE, or within 2 weeks of the first visit for patients joining Cohort A (from
Study PRM-151-202).

- History of smoking within 3 months prior to the first visit in the OLE.

- History of alcohol or substance use disorder within 2 years prior to the first visit
of the OLE or known or suspected active alcohol or substance-use disorder.

- History of severe allergic reaction or anaphylactic reaction to PRM-151.

- Clinically significant abnormality on ECG during eligibility assessment that, in the
opinion of the investigator, may pose an additional risk in administering study drug
to the participant.

- Prolonged corrected QT interval > 450 ms (for men) or > 470 ms (for women) based on
the Fridericia correction formula.

- Clinically significant laboratory test abnormalities (hematology, serumchemistry, and
urinalysis) that, in the opinion of the investigator, may pose an additional risk in
administering study drug to the participant.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 8/17/22. Questions regarding updates should be directed to the study team contact.