Safety, tolerability and pharmacokinetics of Investigator medication in healthy volunteers

JRCT ID: jRCT2071230087

Registered date:09/11/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Healthy participants
• Date of first enrollment: 20/11/2023
• Target sample size: 56
• Study type: Interventional

Intervention(s)

- Cohort A1 to A5, B1 and B2 (n=8 in each 7 cohort)
- Single dose of bispecific antibody (n=6 in each cohort))
- Single dose of placebo (n=2 in each cohort))

Outcome(s)

• Primary Outcome: Treatment emergent adverse events, vital signs, ECG data, laboratory assessments

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 55age old
• Gender: Both

Include criteria

- Able and willing to provide written informed consent.
- Healthy male or non-childbearing potential female participants 18 to 55 years of age, inclusive, at the time of screening, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening and baseline.
- Weigh at least 45.0 kg (female) and 50.0 kg (male) with a body mass index (BMI) within the range of 18.5- 29.9kg/m2

Exclude criteria

- Significant illness, including infectious diseases that has not resolved within 2 weeks prior to baseline, or positive SARS-CoV-2 test result at baseline, or contact with a known case of COVID-19 infection in the 2 weeks prior to baseline.
- Evidence of active or latent Tuberculosis (TB) infection, as determined by T-Spot test at screening.
- Use of other investigational drugs within the last 30 days or 5 half-lives of the other drugs prior to initial dosing, whichever is longer
- Use of any prescription drugs, over-the-counter (OTC) medications, herbal supplements within the last 4 weeks prior to initial dosing.
- Smokers (use of tobacco/nicotine products within 3 months of dosing).

Related Information

• Primary Sponsor: Sato Mika