Bioequivalence Study to Compare Two Injection Devices for BMN 111 in Healthy Participants

Exclusion Criteria

• •1. Any condition considered to affect drug absorption (eg, conditions affecting SC administration such as reduced SC blood flow, lipohypertrophy, and significantly high/low skin temperature).
• •2. Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee).
• •3. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee).
• •4. History of migraines.
• •5. Confirmed (eg, two consecutive measurements) systolic blood pressure \> 140 or \< 90 mmHg, diastolic blood pressure \> 90 or \< 50 mmHg, and pulse rate \> 100 or \< 40 beats per minute or recurrent symptomatic hypotension (defined as episodes of low BP generally accompanied by symptoms e.g., dizziness and fainting) or recurrent symptomatic orthostatic hypotension.
• •6. Positive hepatitis panel and/or positive human immunodeficiency virus test.
• •7. Exposure to mycobacterium tuberculosis, indicative of tuberculosis infection, as confirmed by a positive QuantiFERON-TB Gold test.
• •8. A positive COVID-19 test at Screening or Check-in.
• •9. Taking any of the prohibited medications.
• •10. Administration of a coronavirus disease 2019 (COVID-19) vaccine within 30 days prior to dosing.
• •11. Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to dosing, unless deemed acceptable by the investigator (or designee).
• •12. Use or intend to use any prescription medications/products other than hormone replacement therapy (HRT), oral, implantable, transdermal, injectable, or intrauterine contraceptives within 7 days (or 14 days if the drug is a potential enzyme inducer), or 5 half-lives (whichever is longer), prior to dosing, unless deemed acceptable by the investigator (or designee).
• •13. Use or intend to use slow release medications/products considered to still be active within 14 days prior to Check-in, unless deemed acceptable by the investigator (or designee).
• •14. Use or intend to use any nonprescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant derived preparations within 7 days, or 5 half-lives (whichever is longer), prior to dosing, unless deemed acceptable by the investigator (or designee).
• •15. Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days or 5 half-lives prior to dosing (whichever is longer).
• •16. Have previously completed or withdrawn from this study or any other study investigating BMN 111 and have previously received BMN 111.
• •17. Aspartate aminotransferase, alanine aminotransferase, or bilirubin ≥ 1.5 × upper limit of normal or estimated glomerular filtration rate \< 60 mL/min/1.73m2 (Chronic Kidney Disease Epidemiology Collaboration 2021).
• •18. Receipt of blood products within 2 months prior to Check-in.
• •19. Donation of blood from 3 months prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening.
• •20. Poor peripheral venous access.
• •21. Participants who, in the opinion of the investigator (or designee), should not participate in this study.
• •22. Any skin condition, such as scarring or tattoos, which may preclude receipt of the study drug.
• •23. Unwilling or unable to comply with scheduled visits, the treatment plan, laboratory tests and other study procedures or lifestyle guidance.