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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

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

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The all participants were healthy adult Japanese.The mean age of subjects was 30.2 years (range: 19 - 39) and all participants were male. The mean weight of participants was 62.23 kg (range: 52.1 - 74.1) and mean BMI was 20.91 kg/m2 (range: 17.7 - 24.7).

Each Cohort (1~3) portions of the study consisted of 8 participants of which 2 were randomized to receive placebo and 6 were randomized to receive TIN816. Ono participant discontinued the study after treatment. The discontinuation was not safety related.

- No deaths, serious adverse events (SAEs) and adverse events (AEs) that led to discontinuation of study treatment were observed in the study. - AEs by PT were reported in 19 participants in the study. No Grade >=3 AEs were reported in the TIN816 treatment groups. - One participant in the placebo group had dose interruption due to AEs.

Primary outcome measures - - No deaths, serious adverse events (SAEs) and adverse events (AEs) that led to discontinuation of study treatment were observed in the study. - AEs by PT were reported in 19 participants in the study. No Grade >=3 AEs were reported in the TIN816 treatment groups. - One participant in the placebo group had dose interruption due to AEs. Secondary outcome measures - The peak serum concentrations were typically observed at the first sampling time, which was immediately after the end of dosing. Cmax and AUC exposure increased in a dose proportional manner when increasing doses.

TIN816 was well tolerated in healthy Japanese participants.

No

https://jrct.mhlw.go.jp/latest-detail/jRCT2051230105

Maruyama Hideki

Novartis Pharma. K.K.

Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan

rinshoshiken.toroku@novartis.com

Maruyama Hideki

Novartis Pharma. K.K.

Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan

+81-120-003-293

rinshoshiken.toroku@novartis.com

Complete

Oct. 23, 2023

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

other

- 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.

- 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

Both

Healthy participants

- 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))

All safety endpoints (including adverse events, vital signs, Electrocardiogram (ECG) and safety laboratory)

+81-6-6395-9000

Sept. 22, 2023

none