A Phase 1/1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single and Multiple Ascending Doses of BCX17725 in Healthy Participants and Multiple Doses of BCX17725 in Participants With Netherton Syndrome
This is a first-in-human, Phase 1/1b, 3-part study that includes the evaluation of safety, tolerability, pharmacokinetics (PK), and immunogenicity of BCX17725 when administered via single and multiple doses in healthy adult participants (Parts 1 and 2), and multiple doses in participants with Netherton Syndrome (Part 3).
• Male or non-pregnant, non-lactating female aged 18 to 55 years, inclusive (Parts 1 and 2) or aged 18 to 65 years, inclusive (Part 3)
• Confirmed diagnosis of Netherton syndrome (Part 3 only)
• BMI between 18 and 30 kg/m\^2, inclusive (Parts 1 and 2 only)
• Estimated glomerular filtration rate (eGFR) of ≥ 90 mL/min/1.73 m\^2 (Parts 1 and 2) or ≥ 60 mL/min/1.73 m\^2 (Part 3)
• Agree to follow the protocol contraception requirements from screening until 90 days after the last dose of study drug
• In the opinion of the investigator, expected to adequately comply with all required study procedures and restrictions for the duration of the study