DMB-3111 phase I
- Conditions
- Healthy volunteers
- Registration Number
- JPRN-jRCT2080222436
- Lead Sponsor
- Meiji Seika Pharma Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Male
- Target Recruitment
- 70
1) Healthy Japanese male adults
2) Body Mass Index (BMI) between 17.6 and 26.4 kg/m2 at the time of screening
BMI = Body Weight (kg)/[Height (m)]2
3) The individual who freely consents to participate after receiving a detailed explanation of the clinical study and completely understanding thereof, and who has capacity to follow precautions and provide written consent.
1) History of hypersensitivity to components of Herceptin or Polaramine or any other drug
2) Use of any ethical drug within 2 weeks before investigational product administration or any over-the-counter drug within 1 week before investigational product administration that would affect study participation in the opinion of the investigator or subinvestigators (except for Polaramine, which will be used concomitantly in the present clinical trial and any drug applied locally and having no systemic actions)
3) History of allergic symptoms such as bronchial asthma and urticaria that would affect study participation in the opinion of the investigator or subinvestigators
4) History of cardiac disorders, hypertension, coronary artery disease (e.g., myocardial infarction, angina), and/or vascular disorder; ongoing palpitations, shortness of breath, and/or tachycardia
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacokinetics<br>AUCt,Cmax
- Secondary Outcome Measures
Name Time Method Pharmacokinetics and safety<br>Pharmacokinetics: AUClast, AUCinf, tmax, MRTt, MRTinf, kel, t1/2, and CL<br>safety: Incidence of adverse events and adverse drug reactions related to DMB-3111 and Herceptin (subjective symptoms, objective findings, and laboratory and physiological test results)