A Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of TIN816 in Japanese healthy participants

JRCT ID: jRCT2051230105

Registered date:27/09/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Healthy participants
• Date of first enrollment: 23/10/2023
• Target sample size: 24
• Study type: Interventional

Intervention(s)

- Cohort 1 to 3 (n=8 in each cohort)
- Single dose of TIN816 (n=6 in each cohort))
- Single dose of placebo (n=2 in each cohort))

Outcome(s)

• Primary Outcome: All safety endpoints (including adverse events, vital signs, Electrocardiogram (ECG) and safety laboratory)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 45age old
• Gender: Both

Include criteria

- Japanese healthy male and female participants between the ages of 18 and 45 years, in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
- At screening and baseline, vital signs (systolic and diastolic blood pressure (DBP) and pulse rate) will be assessed in the sitting position and again (when required) in the standing position. Sitting vital signs should be within the following ranges:
- Axillary body temperature between 35.0-37.5 celsius degree
- Systolic blood pressure between 90-139 mm Hg
- Diastolic blood pressure between 50-89 mm Hg
- Pulse rate between 50-90 bpm
- Participants must weigh at least 40 kg at screening to participate in the study and must have a body mass index (BMI) within the range of 18-30 kg/m2.

Exclude criteria

- Concomitant use of anticoagulant and antiplatelet agents (including aspirin) unless they can be permanently discontinued 4 weeks prior to dosing and for the duration of study.
- Use of any prescription drugs or herbal supplements within four weeks prior to initial dosing, and/or over-the-counter (OTC) medication or dietary supplements (vitamins included) within two weeks prior to initial dosing.
- Significant illness (including active infections) which has not resolved within two weeks prior to initial dosing.
- Active and/or chronic infection with Hepatitis B Virus (HBV) or Hepatitis C Virus
(HCV).
- Women of child-bearing potential, defined as all women physiologically capable of
becoming pregnant.
- Smokers

Related Information

• Primary Sponsor: Hirano Takamitsu