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HY6725

Phase 1

Healthy | Monoclonal antibody | Other |Genelux Corporation|Last Updated: Mar 11, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment74

FDA Designations

No designations recorded

Clinical trial landscape

HY6725 · 1 trial · 1 indication

Phase 1 1
NCT07262281Evaluation of the Safety, Tolerability and Pharmacokinetics of HY6725 in Healthy Adult ParticipantsHealthy
RECRUITING74 Analytics
PHASE1RECRUITING
Evaluation of the Safety, Tolerability and Pharmacokinetics of HY6725 in Healthy Adult Participants
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Study Endpoints

Primary Endpoints

Safety data including incidence and severity of TEAEs, SAEs, change from baseline in vital signs, lab values and ECG parameters.
From signing informed consent form to the end of study at Day 150.

Secondary Endpoints

Peak Plasma Concentration (Cmax)
From Day1 predose to Day 150.
Area under the plasma concentration versus time curve (AUC)
From Day1 predose to Day 150.
Time to maximum concentration (Tmax)
From Day1 predose to Day 150.
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeOTHER

Treatment Arms

ArmTypeDescription
HY6725EXPERIMENTALIt's an injection solution. SAD part for subcutaneous dosing in 7 cohorts, including 3mg, 10mg, 30mg, 90mg, 150mg, 300mg and 450mg with only one administration on Day 1 of each cohort. MAD part for subcutaneous dosing in 3 cohorts, including 150mg, 300mg and 450mg with two administrations on Day 1 and Day 30 of each cohort.
placeboPLACEBO_COMPARATORIt's same injection solution just without active ingredient compared with HY6725. SAD part for subcutaneous dosing in 7 cohorts, including 3mg, 10mg, 30mg, 90mg, 150mg, 300mg and 450mg with only one administration on Day 1 of each cohort. MAD part for subcutaneous dosing in 3 cohorts, including 150mg, 300mg and 450mg with two administrations on Day 1 and Day 30 of each cohort.

Interventions

NameTypeDescription
HY6725BIOLOGICALHY6725 is an injection solution with 120mg/ml per vial. SAD part for subcutaneous dosing in 7 cohorts, including 3mg, 10mg, 30mg, 90mg, 150mg, 300mg and 450mg with only one administration on Day 1 of each cohort. MAD part for subcutaneous dosing in 3 cohorts, including 150mg, 300mg and 450mg with two administrations on Day 1 and Day 30 of each cohort.
Placebo ControlOTHERA vial with 1ml injection solution contain same ingredient except HY6725 compared with HY6725 solution.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Male and female participants must be 18 to 55 years of age, inclusive, at the time of signing the informed consent. 2. Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, vital sign assessme...

Countries:Australia
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Frequently asked questions about HY6725

What is HY6725?

HY6725 is an investigational monoclonal antibody being developed by Genelux Corporation. It is currently in Phase 1 clinical development for use in healthy adult participants. The drug is being studied to evaluate its safety, tolerability, and pharmacokinetics.

What is HY6725 used for?

HY6725 is being studied for use in healthy adult participants. The ongoing Phase 1 trial is designed to evaluate the safety, tolerability, and pharmacokinetics of the drug. It is not yet approved for any medical condition and remains in clinical development.

Who makes HY6725?

HY6725 is being developed by Genelux Corporation, a biopharmaceutical company. The company is listed on the stock exchange under the ticker symbol GNLX. Genelux is conducting a Phase 1 clinical trial to evaluate the drug's safety and tolerability in healthy participants.

What phase is HY6725 in?

HY6725 is in Phase 1 clinical development. The drug is currently being evaluated in a Phase 1 trial that is recruiting participants. It is an investigational drug and has not been approved by regulatory authorities for any use.

What clinical trials is HY6725 in?

HY6725 is being studied in a Phase 1 clinical trial with the identifier NCT07262281. The trial is titled "Evaluation of the Safety, Tolerability and Pharmacokinetics of HY6725 in Healthy Adult Participants" and is currently recruiting in Australia. The study plans to enroll 74 healthy adult participants.