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ACTIVE NOT RECRUITING
NCT07848334
PHASE1

First-in-Human Safety and Tolerability Study of OPF-110 in Healthy Adults

Sponsor: Otsuka Pharmaceutical Factory, Inc.

View on ClinicalTrials.gov

Summary

This study will evaluate the safety and tolerability of OPF-110 in healthy adult participants.

Official title: A Phase 1, First-in-human, Randomized, Single-blind, Active-controlled, 2-arm, Parallel-group, Single Ascending Dose Study to Evaluate the Safety and Tolerability of OPF-110 in Healthy Adult Participants.

Key Details

Gender

All

Age Range

18 Years - 64 Years

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2026-08-12

Completion Date

2026-10

Last Updated

2026-10-19

Healthy Volunteers

Yes

Interventions

DRUG

OPF-110

OPF-110 is an investigational 20% lipid injectable emulsion containing fish oil and medium-chain triglycerides administered by intravenous infusion.

DRUG

SMOFLIPID

SMOFlipid is a marketed 20% lipid injectable emulsion containing soybean oil, medium-chain triglycerides, olive oil, and fish oil administered by intravenous infusion.

Locations (1)

CenExel Anaheim (Anaheim Clinical Trials)

Anaheim, California, United States