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

Part of paid clinical trials in Anaheim, California.

Sponsor
Otsuka Pharmaceutical Factory, Inc.
Study ID
NCT07848334
Phase
PHASE1
Status
Recruiting
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Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Accepted

Interventions

  • OPF-110 — DRUG
    OPF-110 is an investigational 20% lipid injectable emulsion containing fish oil and medium-chain triglycerides administered by intravenous infusion.
  • SMOFLIPID — DRUG
    SMOFlipid is a marketed 20% lipid injectable emulsion containing soybean oil, medium-chain triglycerides, olive oil, and fish oil administered by intravenous infusion.

Study Details

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

Key Dates

First listed
Sep 30, 2026
Start date
Aug 12, 2026
Status verified
Sep 2026
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: OPF-110
  • Active Comparator: SMOFLIPID

Primary Outcome Measure

Number of Adverse Events(AEs) [ Time Frame: From Day 1 to Day 10 ]

Central Contacts

  • Clinical Operations Office Clinical Development Department
    +81-3-5280-2721
    [email protected]

Locations (1)

FacilityCityStateZIPSite coordinators
CenExel Anaheim (Anaheim Clinical Trials)AnaheimCalifornia92801
Recruitment Manager
[email protected]
714-774-7777

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By research site
CenExel Anaheim (Anaheim Clinical Trials)· Anaheim, CA

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