Healthy VolunteersPhase 1NCT07848334
First-in-Human Safety and Tolerability Study of OPF-110 in Healthy Adults
A Phase 1 study testing OPF-110 and SMOFLIPID in people with Healthy Volunteers, run by Otsuka Pharmaceutical Factory, Inc. at 1 site in United States.
Trial summary
This study will evaluate the safety and tolerability of OPF-110 in healthy adult participants. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- OPF-110 and SMOFLIPID
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2026to Oct 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
- Ability and willingness to abstain from alcohol from 48 hours prior to IP administration and until Day 10 (EOS).
- Participants are eligible to participate in this study if they are:
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- Of nonchildbearing potential
- Of childbearing potential, and if they agree to use a highly effective form of contraception as per the contraceptive guidance consistently during the study, starting at Screening and until Day 10 (EOS). These participants must have a negative pregnancy test at Screening and Day -1.
- Participants who produce viable sperm and agree to use an adequate method of contraception with a partner of childbearing potential as per the contraceptive guidance consistently during the study, starting at Screening and until the EOS and also refrain from donating sperm during this period. Participants with a partner or partners who is (are) not of childbearing potential are exempt from these requirements.
Who cannot join
- 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.
- Participants who have history or presence of alcohol or drug abuse within the past 2 years prior to Day -1.
- Positive urine drug screen or urine alcohol test at Screening and Day -1.
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- Participants who are unable to refrain from or anticipate using any drug, including prescription and non-prescription medications, herbal remedies, or vitamin supplements from 14 days prior to Day 1 and until Day 10 (EOS).
- Participants who have known hypersensitivity to fish, egg, soybean, peanut or any of the active or inactive ingredients of OPF-110 and SMOFlipid.
- Participants with veins unsuitable for venous blood collection.
- Positive human immunodeficiency virus 1/2, hepatitis B surface antigen, or hepatitis C virus at Screening.
- Participants who have donated blood or had significant blood loss within 56 days prior to Day 1.
- Receipt of any investigational agent or drug within 60 days or 5 half-lives of that drug (whichever is longer) in another clinical study, prior to IP administration on Day 1 in the current study. The 60-day window will be derived from the last blood sampling or dosing date, whichever is later, in the previous study to Day 1 of the current study.
- Participants who are pregnant, breastfeeding, or planning to become pregnant during study
Trial locations and contacts
1 site in 1 country.
United States1 site
CenExel Anaheim (Anaheim Clinical Trials)
Anaheim, California, 92801
About this study
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.
This study will evaluate the safety and tolerability of OPF-110 in healthy adult participants.
- Conditions
- Healthy Volunteers
- Being tested
- OPF-110, SMOFLIPID
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPF-110Drug
OPF-110 is an investigational 20% lipid injectable emulsion containing fish oil and medium-chain triglycerides administered by intravenous infusion.
SMOFLIPIDDrug
SMOFlipid is a marketed 20% lipid injectable emulsion containing soybean oil, medium-chain triglycerides, olive oil, and fish oil administered by intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| OPF-110 | Experimental | Not described Receives: Drug: OPF-110 |
| SMOFLIPID | Active comparator | Not described Receives: Drug: SMOFLIPID |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events(AEs)
Measured: From Day 1 to Day 10
Number of Serious Adverse Events(SAEs)
Measured: From Day 1 to Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start12 Aug 2026
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Otsuka Pharmaceutical Factory, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07848334
- Sponsor's protocol ID
- 664-101
- Status last verified
- Oct 2026
- First submitted
- 7 Aug 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07848334
- Acronym / sponsor ID
- 664-101
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Otsuka Pharmaceutical Factory, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Aug 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 30 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety and tolerability of OPF-110 in healthy adult participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OPF-110 | Experimental | Drug: OPF-110 |
| SMOFLIPID | Active comparator | Drug: SMOFLIPID |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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).
- Ability and willingness to abstain from alcohol from 48 hours prior to IP administration and until Day 10 (EOS).
Key exclusion criteria (13 listed)
- 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.
- Participants who have history or presence of alcohol or drug abuse within the past 2 years prior to Day -1.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OPF-110OPF-110 is an investigational 20% lipid injectable emulsion containing fish oil and medium-chain triglycerides administered by intravenous infusion. | Drug | OPF-110 |
| SMOFLIPIDSMOFlipid is a marketed 20% lipid injectable emulsion containing soybean oil, medium-chain triglycerides, olive oil, and fish oil administered by intravenous infusion. | Drug | SMOFLIPID |
Primary outcome
Number of Adverse Events(AEs)
Time frame: From Day 1 to Day 10
Number of Serious Adverse Events(SAEs)
Time frame: From Day 1 to Day 10
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OPF-110 and SMOFLIPID in people with Healthy Volunteers, run by Otsuka Pharmaceutical Factory, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Adverse Events(AEs) (time frame: From Day 1 to Day 10). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.