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Phase I study of intravenous administration of NMU-HbV as a red blood cell substitute to healthy adult volunteers (HbV-101b)

Phase I study of NMU-HbV as a red blood cell substitute
(HbV-101b)

Matsumoto Masanori

Nara Medical University Hospital

840 Shijo-cho, Kashihara, Nara

mmatsumo@naramed-u.ac.jp

Kasahara Masato

Nara Medical University Hospital

840 Shijo-cho, Kashihara, Nara

+81-744-22-3051

kasa@naramed-u.ac.jp

Recruiting

Mar. 01, 2025

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1) The participant is a healthy Japanese adult
2) The participant from whom obtained written informed consent prior to screening test
3) The participant is an aged 18 and under 50 years at the time of consent acquisition
4) Body weight of 50 to 85 kg at the time of screening test
5) The participant can quit smoking during the period of admission
6)Blood hemoglobin concentration at the time of screening test within the following ranges:
Men: >=12.0 g/dL and <=16.5 g/dL, Women: >=10.0 g/dL and <=14.5 g/dL
7)The participant can access in all the tests of this clinical trial and will be able to complete the clinical trial.

<Exclusion criteria at screening>
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 have received the study drug (NMU-HbV).
10) 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.
11) Positive for infectious disease test [HBs antigen, syphilis test (TPLA method), HCV antibody, HIV antibody] or urinary abuse drug test.
12) Women who are likely to become pregnant* and who have not received contraceptive treatment, who cannot consent to contraception* from the time of obtaining consent until 12 weeks after the end of the study throughout the study period.
* Definition of a woman who may become pregnant
Women between menarche and menopause are considered reproductive unless they are permanently sterilized.
Women who fall under the following items are not considered to be women who may become pregnant.
Pre-menarche
There is evidence of hysterectomy.
There is evidence of bilateral salpingectomy.
There is evidence of bilateral ovariectomy.
Postmenopausal (postmenopausal status is defined as at least 12 months since the last menstrual bleeding without another medical cause) )
13) Men with female partners of childbearing potential who are not receiving contraceptive treatment, or women whose partners are likely to become pregnant and are not receiving contraceptive treatment, who are unable to consent to contraception* from the time of obtaining consent until 12 weeks after the end of the study throughout the study period.
14) 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.)

<Exclusion criteria at the time of pre-dose examination>
1) The participant who participated in other clinical trials and received medication from the time of screening test to the time of hospitalization
2) Use of other drugs within 14 days before hospitalization
3) The participant who are receiving medical treatment from another doctor at the time of hospitalization
4) Ingested foods and beverages containing caffeine and alcohol from 3 days prior to the start of administration of the test drug
5) Other items that the investigator deems inappropriate (e.g., if it is judged that the patient is ineligible to participate in the clinical trial as a result of the pre-administration examination, or if it is expected that it will be difficult to comply with the visit or manage the subject)

Both

Urgent need for blood transfusion

A single-center study designed to evaluate the safety of NMU-HbV administered intravenously to healthy adult in Japan.
Cohort1:100 mL of NMU-HbV (Maintenance dosing rate: 2.5 mL/min)
Cohort2:100 mL of NMU-HbV (Maintenance dosing rate: 5.0 mL/min)
Cohort3:200 mL of NMU-HbV Conduct (Maintenance dosing rate: 5.0 mL/min)
Cohort4:400 mL of NMU-HbV Conduct (Maintenance dosing rate: 5.0 mL/min)
Cohorts start from 1 in order, and after each cohort is observed at the end of the observation period and confirmed by the safety evaluation committee, it moves on to the next cohort.

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.

Pharmacokinetics
To evaluate the concentration of NMU-HbV in the serum from immediately after administration to Day4. 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.

+81-744-22-3051

Dec. 10, 2024

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