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

Completed

• Conditions: Healthy participants

• Registration Number: jRCT2051230105
• Lead Sponsor: Novartis Pharma. K.K.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-27
• Study Start: 2023-10-10
• Last Update Posted: 2025-04-16

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 24

Inclusion 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.

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: parallel assignment

Primary Outcome Measures

Name	Time	Method
adverse events		Safety endpoint including adverse events
vital signs		Safety endpoint including vital signs
safety laboratory		Safety endpoint including safety laboratory
Electrocardiogram (ECG)		Safety endpoint including Electrocardiogram (ECG)