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

ConditionHealthy Volunteers
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-64
SponsorOtsuka Pharmaceutical Factory, Inc.

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Capable of giving signed informed consent , which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and in this protocol.

Healthy participants aged 18 to 64 years (inclusive) at the time of signing the ICF.

Participants who have body mass index (BMI) of ≥18.5 and <30.0 kg/m2 at Screening.

Nonsmoker or occasional smokers (ie, smokes ≤10 cigarettes [or equivalent] per day) or participants who have not used nicotine-containing products within 3 months prior to Day 1, based on participants self-reporting and ability and willingness to refrain from smoking/using nicotine-containing products from Screening and until Day 10 (EOS：End Of Study).

Disqualifiers

Participants who have hypertriglyceridemia (serum triglyceride levels of >150 mg/dL) at Screening.

Participants who are mentally or legally incapacitated or have significant emotional problems at the time of the Screening or anticipated during the study.

Participants who have history or presence of clinically significant medical or psychiatric condition or disease (such as Type I or Type II diabetes mellitus) that, in the opinion of the Investigator (or designee), might confound the results of the study or pose an additional risk to the participant safety.

Participants with clinically significant findings from physical examination, clinical safety laboratory results, vital signs, or ECGs, as deemed by the Investigator (or designee) at Screening.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: OPF-110Experimental treatment 1 intervention
Group B: SMOFLIPIDActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of Adverse Events(AEs)

Time frame
From Day 1 to Day 10
2

Number of Serious Adverse Events(SAEs)

Time frame
From Day 1 to Day 10

Secondary outcomes

Other outcomes

1

Change in Total Protein

This measure evaluates total protein as a biomarker of nutritional efficacy. Unit of measure: g/dL

Time frame
Day1, Day2
2

Change in Albumin

This measure evaluates albumin as a biomarker of nutritional efficacy. Unit of measure: g/dL

Time frame
Day1, Day2
3

Change in Total Cholesterol

This measure evaluates total cholesterol as a biomarker of nutritional efficacy. Unit of measure: mg/dL

Time frame
Day1, Day2
4

Change in Triglycerides

This measure evaluates triglycerides as a biomarker of nutritional efficacy. Unit of measure: mg/dL

Time frame
Day1, Day2

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Otsuka Pharmaceutical Factory, Inc.

Lead sponsor

Source ClinicalTrials.gov
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