Repeat-dose study of JBP-TPOXX in Japanese healthy subjects (Phase I study)

JRCT ID: jRCT2031230327

Registered date:05/09/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Mpox, smallpox, cowpox,and omplications occurred by proliferation of vaccinia virus after smallpox
• Date of first enrollment: 04/07/2023
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Subjects will take JBP-TOPOXX 3 capsules (600 mg) twice a day for 14 days as approximately 12 hours (+/-30 minutes) between each dose within 30 minutes after eating. As a recommendation, the meal before dosing should be containing approximately 600 kcal and 25 g of fat.

Outcome(s)

• Primary Outcome: Type, frequency, and severity of adverse events that occurred during the study treatment period and the observation period (Days 1 to 28).
• Secondary Outcome: Concentrations of tecobilimato and tecobilimato metabolites (M4, M5 and TFMBA) and pharmacokinetic parameters in plasma after repeated administration of the investigational product twice daily for 14 days.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 50age old
• Gender: Both

Include criteria

Personnel who meet all of the following criteria shall be eligible:
1)Subjects who obtained written consent of the subject's own free will for participation in the clinical trial.
2)Age at the time of informed consent: 18 to 50 years
3)Persons with a Body Mass Index (BMI) of 18.5 kg/m2 or more and less than 25.0 kg/m2 at screening

Exclude criteria

Any person who falls under any of the following criteria shall be disqualified:
1) Patients with a past history of anaphylaxis due to food or medicine
2) Patients with a history of serious cardiovascular system, blood system, respiratory system, liver, kidney, gastrointestinal system, psychoneurological system, or present medical history
3) Persons with a history of convulsions or epilepsy
4) Persons with a history of immunodeficiency
5) Persons with relatives (within the third degree) with congenital immunodeficiency
6) Persons with a current history of bronchial asthma
7) Smokers or those who quit smoking within 6 months of hospitalization
8) Persons who are alcoholic or have a history of alcoholism
9) Patients with uncontrolled hypertension (systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg)
10) Persons with a positive drug abuse test result at screening or persons with a history of drug dependence
11) Patients with a positive immunological test (HBsAg, HCV antibody, HIV antigen/antibody, serologic test for syphilis) at screening.
12) Patients with clinically significant abnormalities on screening ECG or QTcF > 450 msec
13) Patients with clinically significant abnormalities in screening laboratory tests
14) Subjects who cannot refrain from using drugs or herbal supplements, including over-the-counter drugs, from the date of informed consent until 48 hours after the completion of administration of the investigational drug
15) Women who wish to become pregnant or who are pregnant or breastfeeding during the period from study entry to the first dose of study drug 12 weeks later. Men of women of childbearing potential and their sexual partners should use oral contraceptives (pill), condom, vasectomy, tubal ligation, diaphragm, intrauterine diaphragm, spermicide, intrauterine hormone release system, etc. from the day of study until 12 weeks after the first administration of the investigational product.
16) Subjects who participated in a clinical study of other unapproved drugs within 4 weeks before the start of the clinical study (the date of reckoning shall be the date of administration of the investigational product) and received the investigational product.
17) Patients with a travel overseas within 4 weeks before the start of the clinical trial (the date of reckoning is the date of administration of the investigational product).
18) Individuals unable to comply with and follow up on the protocol (due to psychological, family, social, geographic, etc.)
19) Other subjects who were considered by the investigator (or subinvestigator) to be ineligible for the study.

Related Information

• Primary Sponsor: Arai Masumi