A Study of BBP-711 (ORF-229) in Healthy Adult Volunteers

A Phase 1, Randomized, Double-Blinded, Placebo-controlled, Single and Multiple-Ascending Dose Study of the Safety, Tolerability, Food Effect, Pharmacokinetics, and Pharmacodynamics of BBP-711 (ORF-229) in Healthy Adult Subjects

The purpose of this study is to evaluate the safety and tolerability of BBP-711 in healthy adult volunteers.

This is a single-center, two-part, randomized, double-blinded, placebo-controlled, ascending dose study of BBP-711 in healthy male and female adult volunteers. The purpose of this study is to evaluate the safety and tolerability of BBP-711 in healthy adult volunteers. Each volunteer will participate in the study for about 20 days.

Inclusion Criteria:

• Adult male or female who is 18 to 65 years old,
• Weight >50 kg and ≤110 kg at Screening
• Body mass index (BMI) 20 to 32 kg/m2, inclusive, at Screening
• In generally good health
• Nonsmoker, or not using tobacco or nicotine-containing products for at least 6 months

Exclusion Criteria:

• Use of any over-the-counter medications, including herbals or routine vitamins or minerals, or other supplements, within 7 days before admission to the research center.
• Pregnant or breastfeeding
• eGFR <90 mL/minute
• Abnormal ECG
• Abnormal laboratory results
• Positive test result for HIV, Hepatitis B, Hepatitis C, or COVID-19
• History of substance dependency (alcohol or other drugs of abuse) in the last 2 years
• Use of study drug in any clinical trial within 30 days of admission to the research center, or in the active follow-up phase of another clinical trial involving study drug