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

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.

Inclusion Criteria:

1. 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.
2. Healthy participants aged 18 to 64 years (inclusive) at the time of signing the ICF.
3. Participants who have body mass index (BMI) of ≥18.5 and \<30.0 kg/m2 at Screening.
4. 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).
5. Ability and willingness to abstain from alcohol from 48 hours prior to IP administration and until Day 10 (EOS).
6. Participants are eligible to participate in this study if they are:

1. Of nonchildbearing potential
2. 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.
3. 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.

Exclusion Criteria:

1. Participants who have hypertriglyceridemia (serum triglyceride levels of \>150 mg/dL) at Screening.
2. Participants who are mentally or legally incapacitated or have significant emotional problems at the time of the Screening or anticipated during the study.
3. 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.
4. 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.
5. Participants who have history or presence of alcohol or drug abuse within the past 2 years prior to Day -1.
6. Positive urine drug screen or urine alcohol test at Screening and Day -1.
7. 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).
8. Participants who have known hypersensitivity to fish, egg, soybean, peanut or any of the active or inactive ingredients of OPF-110 and SMOFlipid.
9. Participants with veins unsuitable for venous blood collection.
10. Positive human immunodeficiency virus 1/2, hepatitis B surface antigen, or hepatitis C virus at Screening.
11. Participants who have donated blood or had significant blood loss within 56 days prior to Day 1.
12. 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.
13. Participants who are pregnant, breastfeeding, or planning to become pregnant during study

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

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

Not reported.

Not reported.