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BX002-A

Phase 1

Undisclosed | Monoclonal antibody | Other |BiomX Inc.|Trials Updated: Jan 25, 2022

BX002-A development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Feb 2021

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

BX002-A clinical trials

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
Healthy VolunteersUnlock trial analytics

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?

BX002-A is an investigational monoclonal antibody being developed by BiomX Inc. It has been studied in a Phase 1 clinical trial in healthy adult volunteers in the United States. The specific disease indications for BX002-A have not been disclosed.

Who is developing BX002-A?

BX002-A is being developed by BiomX Inc., which trades on the NYSE American under the ticker PHGE. BiomX is the sponsor of the clinical program for this monoclonal antibody candidate.

What phase is BX002-A in?

BX002-A is in Phase 1 development. It has completed one Phase 1 clinical trial, NCT04737876, which evaluated safety, tolerability, and fecal pharmacokinetics in healthy adults. There are currently no active trials of BX002-A.

What clinical trials is BX002-A in?

BX002-A has been studied in one clinical trial: NCT04737876, titled "A Study to Evaluate the Safety, Tolerability, and Fecal Pharmacokinetics of BX002-A in Healthy Adults." This Phase 1 trial was completed, enrolled 18 participants, was randomized and placebo-controlled, and was conducted in the United States.

Is BX002-A FDA approved?

BX002-A is not approved; it is an investigational monoclonal antibody still in clinical development. Its only completed trial was a Phase 1 study in healthy volunteers, and no active trials are ongoing.