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BBP-711

Phase 1

Healthy | Small molecule | Other |BridgeBio Pharma, Inc.|Last Updated: Mar 21, 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment92

FDA Designations

No designations recorded

Clinical trial landscape

BBP-711 · 1 trial · 1 indication

Phase 1 1
NCT04876924A Study of BBP-711 (ORF-229) in Healthy Adult VolunteersHealthy
COMPLETED92 Analytics
PHASE1COMPLETED
A Study of BBP-711 (ORF-229) in Healthy Adult Volunteers
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Study Endpoints

Primary Endpoints

Safety and Tolerability
Baseline to Day 20

Incidence of Adverse Events (AEs)

Secondary Endpoints

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
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
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
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BBP-711 for SADEXPERIMENTALA single dose of BBP-711 will be administered orally.
Placebo for SADPLACEBO_COMPARATORA single dose of matching placebo will be administered orally.
BBP-711 for MADEXPERIMENTALA dose of BBP-711 will be administered orally for multiple days.
Placebo for MADPLACEBO_COMPARATORA dose of matching placebo will be administered orally for multiple days.
BBP-711 for SAD Food EffectEXPERIMENTALA single dose of BBP-711 will be administered orally.
Placebo for SAD Food EffectPLACEBO_COMPARATORA single dose of matching placebo will be administered orally.

Interventions

NameTypeDescription
BBP-711DRUGBBP-711, oral suspension
PlaceboDRUGPlacebo matching BBP-711
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 Exclusi...

Countries:United States
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Frequently asked questions about BBP-711

What is BBP-711 used for?

BBP-711 is an investigational small molecule being studied in healthy adult volunteers. It is currently in Phase 1 clinical development, and the completed trial evaluated its safety and tolerability in healthy participants. BBP-711 is not approved for any medical condition and remains in early-stage clinical testing.

Who makes BBP-711?

BBP-711 is being developed by BridgeBio Pharma, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol BBIO. The company is conducting clinical research on this investigational small molecule in healthy volunteers.

What phase is BBP-711 in?

BBP-711 is in Phase 1 clinical development. The single completed Phase 1 trial enrolled 92 healthy adult volunteers in the United States. As an investigational drug, BBP-711 has not been approved by regulatory authorities and is still in early-stage clinical testing.

What clinical trials is BBP-711 in?

BBP-711 has one completed Phase 1 clinical trial registered as NCT04876924, titled "A Study of BBP-711 (ORF-229) in Healthy Adult Volunteers." This randomized, double-blind, placebo-controlled study enrolled 92 healthy participants aged 18 years and older in the United States.

Is BBP-711 the same as ORF-229?

Yes, BBP-711 is also known as ORF-229. The clinical trial NCT04876924, which studied BBP-711 in healthy adult volunteers, refers to the drug as BBP-711 (ORF-229), confirming that these names refer to the same investigational compound.