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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04876924

Enrollment

Registered

2021-05-07

Start date

2021-04-29

Completion date

2022-02-27

Last updated

2022-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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

Detailed description

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.

Interventions

DRUGBBP-711

BBP-711, oral suspension

DRUGPlacebo

Placebo matching BBP-711

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Safety and Tolerability	Baseline to Day 20	Incidence of Adverse Events (AEs)

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026