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Active Not Recruiting
NCT07848334
First-in-Human Safety and Tolerability Study of OPF-110 in Healthy Adults
Conditions: Healthy Volunteers
Sex: All
Ages: 18 Years – 64 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 24
Sponsor: Otsuka Pharmaceutical Factory, Inc.
Location: CenExel Anaheim (Anaheim Clinical Trials) Anaheim California
Summary
This study will evaluate the safety and tolerability of OPF-110 in healthy adult participants.
Eligibility Criteria
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 \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
Source: ClinicalTrials.gov (NCT07848334). StuddyBuddy aggregates publicly available trial information.