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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: BBP-711
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BBP-711 for SAD<br>A single dose of BBP-711 will be administered orally. | Drug: BBP-711<br>* BBP-711, oral suspension<br>|
| Placebo Comparator: Placebo for SAD<br>A single dose of matching placebo will be administered orally. | Drug: Placebo<br>* Placebo matching BBP-711<br>|
| Experimental: BBP-711 for MAD<br>A dose of BBP-711 will be administered orally for multiple days. | Drug: BBP-711<br>* BBP-711, oral suspension<br>|
| Placebo Comparator: Placebo for MAD<br>A dose of matching placebo will be administered orally for multiple days. | Drug: Placebo<br>* Placebo matching BBP-711<br>|
| Experimental: BBP-711 for SAD Food Effect<br>A single dose of BBP-711 will be administered orally. | Drug: BBP-711<br>* BBP-711, oral suspension<br>|
| Placebo Comparator: Placebo for SAD Food Effect<br>A single dose of matching placebo will be administered orally. | Drug: Placebo<br>* Placebo matching BBP-711<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability | Incidence of Adverse Events (AEs) | Baseline to Day 20 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic Assessments: Cmax | Maximum observed plasma concentration (Cmax) | Blood samples will be taken pre-dose up to Day 10 for SAD and pre-dose up to Day 20 for MAD | 
| Pharmacokinetic Assessments: Cmin | Minimum observed plasma concentration (Cmin) | Blood samples will be taken pre-dose up to Day 10 for SAD and pre-dose up to Day 20 for MAD | 
| Pharmacokinetic Assessments: AUC | Area under the plasma concentration-time curve from 0 to last measurable concentration (AUC(0-last)) computed using the linear trapezoidal rule | Blood samples will be taken pre-dose up to Day 10 for SAD and pre-dose up to Day 20 for MAD | 
| Pharmacodynamic Assessment: Baseline plasma glycolate | Baseline plasma glycolate | Baseline | 
| Pharmacodynamic Assessment: Percentage change from baseline plasma glycolate | Percentage change from baseline plasma glycolate | Blood samples will be taken pre-dose up to Day 10 for SAD and pre-dose up to Day 20 for MAD | 
| Pharmacodynamic Assessment: Baseline 24 Hour urinary glycolate:creatinine ratio | Baseline 24 Hour urinary glycolate:creatinine ratio | Baseline | 
| Pharmacodynamic Assessment: Percentage change from baseline of 24 Hour urinary glycolate:creatinine ratio | Percentage change from baseline of 24 Hour urinary glycolate:creatinine ratio | Urine samples will be taken pre-dose up to Day 3 for SAD and pre-dose up to Day 7 for MAD |