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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04876924
• Other study ID #: ORF-01-001
• Status: Completed
• Phase: Phase 1
• Start date: April 29, 2021
• Est. completion date: February 27, 2022

Study information

• Verified date: March 2022
• Source: Cantero Therapeutics, a BridgeBio company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: February 27, 2022
• Est. primary completion date: February 27, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• BBP-711
BBP-711, oral suspension
• Placebo
Placebo matching BBP-711

Locations

Country	Name	City	State
United States	Celerion	Tempe	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Cantero Therapeutics, a BridgeBio company	Celerion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability	Incidence of Adverse Events (AEs)	Baseline to Day 20
Secondary	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
Secondary	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
Secondary	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
Secondary	Pharmacodynamic Assessment: Baseline plasma glycolate	Baseline plasma glycolate	Baseline
Secondary	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
Secondary	Pharmacodynamic Assessment: Baseline 24 Hour urinary glycolate:creatinine ratio	Baseline 24 Hour urinary glycolate:creatinine ratio	Baseline
Secondary	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