Phase I study of NMU-HbV as a red blood cell substitute

JRCT ID: jRCT2011200004

Registered date:13/10/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Urgent need for blood transfusion
• Date of first enrollment: 19/10/2020
• Target sample size: 12
• Study type: Interventional

Intervention(s)

A single-center study designed to evaluate the safety of NMU-HbV administered intravenously to healthy adult males in Japan.
Cohort1:10 mL of NMU-HbV Cohort2:50 mL of NMU-HbV Cohort3:100 mL of NMU-HbV
Conduct Cohort 2 after Cohort 1 is completed and Cohort 3 after Cohort 2 is completed.

Outcome(s)

Primary Outcome

Safety
To evaluate adverse events until 14 days after administration
To evaluate clinically serious changes until day 3 (72 hours) after administration
Clinical symptoms, vital signs, the findings of electrocardiogram, and laboratory data from baseline (before administration) to day 3 compared to that in baseline.

Secondary Outcome

Pharmacokinetics
To evaluate the concentration of NMU-HbV in the serum from immediately after administration to Day15. In addition, the maximum blood concentration (Cmax), the time to reach the maximum blood concentration (Tmax), the area under the blood concentration-time curve (AUC), and the elimination half-life (T1/2) of NMU-HbV are calculated by the formula.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 50age old
• Gender: Male

Include criteria

1) The participant is a healthy Japanese adult male
2) The participant from whom obtained written informed consent prior to screening test
3) The participant is an aged 20 to 50 years at the time of consent acquisition
4) Body weight of 50 to 85 kg, and BMI of 18.5 to 25.0 at the time of screening test
5) The participant can quit smoking during the period of admission
6) The participant can access in all the tests of this clinical trial and will be able to complete the clinical trial.

Exclude criteria

1) The participant who have a clinically relevant history or current treatment with surgical operation within 4 weeks before registration.
2) The participant with a clinically history or current treatment of hepato-renal-cardiac dysfunction
3) The participant with a history or presence of drugs and liposome allergies
4) The participant with a history of alcohol or drug dependence
5)The participant who donated 400 ml whole blood within 4 months, 200 ml whole blood within 2 months or blood component within 14 days before the screening test.
6) The participant who have used prescription drugs or over-the-counter drugs (including crude drugs) 14 days before the screening test. However, topical disinfectants, eye drops, etc. that the principal investigator(s) is not considered to have any effect even when used, such as no systemic exposure, are allowed.
7) The participant who plans to join in other clinical trials or post-marketing clinical trials together with this clinical trial.
8) The participant who joined in another clinical trial 4 months (starting from the last administration date) before the screening test and received the investigational drug.
9) The participant who is suspected to need some therapy for current symptoms or organ dysfunction with abnormal vital signs or laboratory data at the time of screening. However, those who is excluded that principal investigator(s) have judged appropriate condition for participation in this study.
10) Positive for infectious disease test [HBs antigen, syphilis test (TPLA method), HCV antibody, HIV antibody] or urinary abuse drug test
11) In case of the participant with partner possible to be pregnant, participant who did not have sexual intercourse without contraception and consent to adopt highly effective contraceptive method* from the registration through 12 weeks after discontinuation of the clinical trial.
12) In addition, those judged by the principal investigator(s) to be inappropriate for this clinical trial (when it is suspected that it will be difficult for the subject to visit phase I unit or to keep the subject under control)
* Use medically appropriate methods of contraception (condoms, contraceptive pills, etc.)

Related Information

• Primary Sponsor: Amano Toraji
• Secondary Sponsor: Azuma Hiroshi
• Source(s) of Monetary Support: AMED