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

Cantero Therapeutics, a BridgeBio company92 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

BBP-711DRUG

BBP-711, oral suspension

PlaceboDRUG

Placebo matching BBP-711

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Celerion

Tempe, Arizona, United States

Outcomes

Primary Outcomes

Safety and Tolerability

Incidence of Adverse Events (AEs)

Time frame: Baseline to Day 20

Secondary Outcomes

Pharmacokinetic Assessments: Cmax

Maximum observed plasma concentration (Cmax)

Time frame: 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)

Time frame: 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

Time frame: 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

Time frame: Baseline

Pharmacodynamic Assessment: Percentage change from baseline plasma glycolate

Percentage change from baseline plasma glycolate

Time frame: 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

Time frame: Baseline

Data from ClinicalTrials.gov

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