DMB-3111 phase I

Bioequivalence Study Evaluating the Pharmacokinetics of DMB-3111 and Herceptin in Healthy Japanese Male Adults

Status

Unknown

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222436

Enrollment

Registered

2014-03-25

Start date

2014-03-25

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 volunteers

Interventions

investigational material(s) Generic name etc : DMB-3111 INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics AUCt,Cmax	—

Secondary

Measure	Time frame
Pharmacokinetics and safety Pharmacokinetics: AUClast, AUCinf, tmax, MRTt, MRTinf, kel, t1/2, and CL 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)	—

Outcome results

None listed

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