Clinical trial NCT04876924: A Study of BBP-711 (ORF-229) in Healthy Adult Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Cantero Therapeutics, a BridgeBio company
Sponsor class: INDUSTRY
Collaborators: name: Celerion
First posted: 2021-05-07
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety and Tolerability
timeFrame: Baseline to Day 20
Secondary outcomes:
measure: Pharmacokinetic Assessments: Cmax
timeFrame: Blood samples will be taken pre-dose up to Day 10 for SAD and pre-dose up to Day 20 for MAD
measure: Pharmacokinetic Assessments: Cmin
timeFrame: Blood samples will be taken pre-dose up to Day 10 for SAD and pre-dose up to Day 20 for MAD
measure: Pharmacokinetic Assessments: AUC
timeFrame: Blood samples will be taken pre-dose up to Day 10 for SAD and pre-dose up to Day 20 for MAD
measure: Pharmacodynamic Assessment: Baseline plasma glycolate
timeFrame: Baseline
measure: Pharmacodynamic Assessment: Percentage change from baseline plasma glycolate
timeFrame: Blood samples will be taken pre-dose up to Day 10 for SAD and pre-dose up to Day 20 for MAD
measure: Pharmacodynamic Assessment: Baseline 24 Hour urinary glycolate:creatinine ratio
timeFrame: Baseline
measure: Pharmacodynamic Assessment: Percentage change from baseline of 24 Hour urinary glycolate:creatinine ratio
timeFrame: Urine samples will be taken pre-dose up to Day 3 for SAD and pre-dose up to Day 7 for MAD
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Celerion
state: Arizona
Study officials:
affiliation: Celerion
name: Terry O'Reilly, MD
role: PRINCIPAL_INVESTIGATOR
References: