Phase 1, Single Ascending Dose Study of Subcutaneous BW-50218 in Healthy Participants

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered BW-50218 in Healthy Participants

Inclusion Criteria:

• Capable of providing written informed consent and complying with all study procedures for the duration of the study.
• Body weight and body mass index (BMI) within a range considered appropriate for study participation by the investigator.
• Female participants must be non-pregnant, non-lactating, and either of non-childbearing potential or using highly effective contraception.
• Male participants with partners of childbearing potential must agree to use effective contraception.

Exclusion Criteria:

• Any medical condition, recent illness, or laboratory result that, in the investigator's opinion, may increase risk or interfere with participation in the study.
• Recent hospitalization or a significant acute medical event.
• History of cancer or any long-term medical condition that the study doctor considers clinically relevant.
• Clinical laboratory findings outside of range which are deemed clinically significant by the investigator at screening or Day -1.
• Positive test for hepatitis B, hepatitis C, or HIV.

A decision regarding sharing of de-identified IPD will be made by the Sponsor after study completion and will consider scientific merit, participant privacy, and regulatory requirements.