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BX002-A

Phase 1

Healthy Volunteers | Monoclonal antibody | Other |BiomX Inc.|Last Updated: Jan 25, 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedPLACEBO_CONTROLLED
Total Trials1
Total Enrollment18

FDA Designations

No designations recorded

Clinical trial landscape

BX002-A · 1 trial · 1 indication

Phase 1 1
NCT04737876A Study to Evaluate the Safety, Tolerability, and Fecal Pharmacokinetics of BX002-A in Healthy AdultsHealthy Volunteers
COMPLETED18 Analytics
PHASE1COMPLETED
A Study to Evaluate the Safety, Tolerability, and Fecal Pharmacokinetics of BX002-A in Healthy Adults
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Study Endpoints

Primary Endpoints

Safety and Tolerability: adverse events
Through study completion Day 31 (+ 2 days)

Evaluated by reviewing adverse events

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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeOTHER

Treatment Arms

ArmTypeDescription
BX002-AEXPERIMENTALBX002-A: 1 mL liquid for multiple dose oral administration
PlaceboPLACEBO_COMPARATORPlacebo: 1 mL liquid for multiple dose oral administration

Interventions

NameTypeDescription
BX002-ABIOLOGICALbacteriophage cocktail
PlaceboOTHERPlacebo
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Healthy adults 18-65 years old 2. Able to understand study procedures and sign informed consent Exclusion Criteria: 1. Evidence or history of clinically significant underlying conditions 2. Women who are pregnant or nursing, or plan to become pregnant during study, or women...

Countries:United States
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Frequently asked questions about BX002-A

What is BX002-A used for?

BX002-A is an investigational monoclonal antibody being studied in healthy volunteers. It is currently in Phase 1 clinical development, with a completed trial evaluating its safety, tolerability, and fecal pharmacokinetics in healthy adults. BX002-A is not approved for any indication and remains under investigation.

Who makes BX002-A?

BX002-A is being developed by BiomX Inc., a biopharmaceutical company. BiomX Inc. is publicly traded under the ticker symbol PHGE. The company is conducting clinical research on BX002-A as an investigational monoclonal antibody.

What phase is BX002-A in?

BX002-A is in Phase 1 clinical development. A Phase 1 trial has been completed, which studied the safety, tolerability, and fecal pharmacokinetics of BX002-A in healthy adults. BX002-A is investigational and has not been approved by regulatory authorities.

What clinical trials is BX002-A in?

BX002-A has one completed clinical trial, identified as NCT04737876. This Phase 1 study evaluated the safety, tolerability, and fecal pharmacokinetics of BX002-A in healthy adults in the United States. The trial enrolled 18 participants and was placebo-controlled.

Is BX002-A FDA approved?

No, BX002-A is not FDA approved. It is an investigational monoclonal antibody currently in Phase 1 clinical development. A Phase 1 trial in healthy volunteers has been completed, but BX002-A has not received approval for any medical use.