A Phase 1 interventional study of BBP-711 and Placebo in Healthy, sponsored by Cantero Therapeutics, a BridgeBio company. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-21.
Sponsored by Cantero Therapeutics, a BridgeBio company · Phase 1, Interventional, and Treatment
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.
This is the only study on the registry with Cantero Therapeutics, a BridgeBio company as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
A single dose of BBP-711 will be administered orally.
Drug: BBP-711
A single dose of matching placebo will be administered orally.
Drug: Placebo
A dose of BBP-711 will be administered orally for multiple days.
Drug: BBP-711
A dose of matching placebo will be administered orally for multiple days.
Drug: Placebo
A single dose of BBP-711 will be administered orally.
Drug: BBP-711
A single dose of matching placebo will be administered orally.
Drug: Placebo
BBP-711, oral suspension
Placebo matching BBP-711
Safety and Tolerability
Incidence of Adverse Events (AEs)
Time frame: Baseline to Day 20
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
Pharmacodynamic Assessment: Percentage change from baseline of 24 Hour urinary glycolate:creatinine ratio
Percentage change from baseline of 24 Hour urinary glycolate:creatinine ratio
Time frame: Urine samples will be taken pre-dose up to Day 3 for SAD and pre-dose up to Day 7 for MAD
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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