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

A Phase 1, randomized, participant- and investigatorblinded, placebo-controlled, single ascending dose study to investigate the safety, tolerability and pharmacokinetics of TIN816 in Japanese healthy participants

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2051230105

Enrollment

Registered

2023-09-27

Start date

2023-10-10

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy participants

Interventions

- 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))

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
All safety endpoints (including adverse events, vital signs, Electrocardiogram (ECG) and safety laboratory)	—

Contacts

Public ContactHideki Maruyama

Novartis Pharma. K.K.

rinshoshiken.toroku@novartis.com+81-120-003-293

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026