A single-center, open-label, uncontrolled study to evaluate the safety and tolerability of EVA101 with non-oxygenated perfluorodecalin (PFD) in healthy male volunteers

JRCT ID: jRCT2052240047

Registered date:30/05/2024

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Healthy Male Subjects
• Date of first enrollment: 21/06/2024
• Target sample size: 27
• Study type: Interventional
• Intervention(s): A single infusion of PFD is made into the rectum to maintain PFD to accumulate in the intestine for 60 minutes after the start of infusion. Discharged PFD through rectum to collect using a simple toilet or other means

Outcome(s)

Primary Outcome

Adverse events, laboratory tests (hematology, blood biochemistry, erythrocyte sedimentation rate, urinalysis), vital signs (systolic/diastolic blood pressure, pulse rate, respiratory rate, temperature), electrocardiogram
Transcutaneous arterial blood oxygen saturation, partial pressure of carbon dioxide (non-invasive transcutaneous measurement)
Effect on bowel movements
PFD recovery rate

• Secondary Outcome: PFD Blood Concentration

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 45age old
• Gender: Male

Include criteria

(1) Healthy male Japanese (all relatives within the second degree of kinship are Japanese)
(2) Age between 20 and 45 years old at the time of consent
(3) BMI between 18.5 and 25.0
(4) Able to abstain from smoking and alcohol during hospitalization
(5) Have no clinically relevant abnormalities in clinical examination (hematology, blood biochemistry, erythrocyte sedimentation rate, urinalysis) results, electrocardiogram, or vital signs at the time of screening
(6) Must be able to sign the ICF, including compliance with the requirements and restrictions described in the Informed Consent Form (ICF) and this study protocol.

Exclude criteria

(1) Patients with a concomitant or pre-existing metabolic, endocrine, hepatic, renal, hematologic, cardiovascular, gastrointestinal, urologic, immunologic, neurologic, or psychiatric disorder with significant and clinical manifestations that are judged by the investigator or subinvestigator to be inappropriate for this clinical trial
(2) Patients with lower gastrointestinal diseases such as hemorrhoids, irritable bowel syndrome, inflammatory bowel disease, colon polyps, diverticula, and those with a history of abdominal surgery.
(3) Patients with chronic constipation or tendency to defecate
(4) Subjects with chronic diarrhea or acute diarrhea prior to use of the device under study
(5) Patients with perforation or suspected perforation of the intestinal tract, or acute bleeding in the intestinal tract
(6) Persons with hypersensitivity or allergy (or suspected allergy) to materials used in the clinical trial, or with a history of such hypersensitivity or allergy.
(7) The subject has taken other drugs or supplements within 2 weeks prior to the use of the investigational device, or is required to take other drugs or supplements by the end of the clinical trial.
(8) Persons who have consumed alcohol in the 24 hours prior to the screening test and from 2 days prior to admission to the hospital to the time of admission
(9) Patients with a history of alcoholism or drug dependence
(10) Positive alcohol or drug of abuse tests at the time of screening and admission
(11) Positive hepatitis B, hepatitis C, HIV or syphilis test at the time of screening test
(12) Whole blood samples of 400 mL within 12 weeks, whole blood samples of 200 mL within 4 weeks, or component blood samples (plasma and platelet) within 2 weeks prior to the use of the test device
(13) Who participated in another clinical trial within 3 months prior to obtaining consent, and for whom the investigational drug or device was administered or used, or who is scheduled to participate in another clinical trial during the period of this study
(14) Persons who have participated in other clinical studies within 3 months prior to obtaining consent and have received any drug or procedure related to such studies, or are scheduled to participate in such clinical studies during the term of this clinical trial (excluding backward-looking observational studies).
(15) Employees of the sponsor, their family members, or persons in a dependent relationship (e.g., husband and wife, parents, children, siblings) with employees of the sponsor or others involved in the conduct of this clinical study, or persons who may consent under coercion
(16) Persons who are judged by the investigator or subinvestigator to be inappropriate to participate in this clinical trial

Related Information

• Primary Sponsor: Chihiro Yokota
• Secondary Sponsor: Payment In-Kind including labor, system, know-how and administartion to conduct clinical trial