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NOT YET RECRUITING
NCT07808905
PHASE1/PHASE2

Evaluate the Efficacy and Safety of EN001 in Patients With Sarcopenia

Sponsor: ENCell

View on ClinicalTrials.gov

Summary

A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase 1/2 Clinical Trial to Evaluate the Efficacy and Safety of EN001 in Patients with Sarcopenia

Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase 1/2 Clinical Trial to Evaluate the Efficacy and Safety of EN001 in Patients With Sarcopenia

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

132

Start Date

2027-03-01

Completion Date

2029-10-31

Last Updated

2026-09-11

Healthy Volunteers

No

Conditions

Interventions

DRUG

EN001

\- Phase1-Cohort 1: EN001 Low dose administered intravenously (IV) 3 times at 4 week intervals.

DRUG

EN001

-Phase2-Cohort 2 : EN001 Medium dose administered intravenously (IV) 3times at 4 week intervals.

DRUG

EN001

-Phase1-Cohort 3 : EN001 High dose administered intravenously (IV) 3times at 4 week intervals.

DRUG

EN001

-Phase2-Cohort 1 : EN001 Low dose(Recommended Phase 2 Dose\[RP2D\] of EN001) administered intravenously (IV) 3times at 4 week intervals.

DRUG

EN001

-Phase2-Cohort2 : EN001 High dose(Recommended Phase 2 Dose\[RP2D\] of EN001) administered intravenously (IV) 3times at 4 week intervals.

DRUG

EN001 Placebo

-Phase2-Placebo : EN001 Placebo administered intravenously (IV) 3times at 4 week intervals.

Locations (1)

Samsung Medical Center

Seoul, South Korea