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

Phase Ib 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)Healthy Japanese adults
2)Written informed consent obtained prior to screening
3) Age at the time of obtaining informed consent: 18 years or older and less than 50 years
4) Body weight at the time of screening: 40 kg or more and less than 85 kg
5)Able to abstain from smoking during hospitalization
6)Blood hemoglobin concentration at screening within the following ranges:
Males: >=12.0 and <=16.5 g/dL, Female: >=10.0 and <=14.5 g/dL
7)Able to participate in all examinations required in this clinical study and are expected to complete the study

<Exclusion criteria at screening>
1)History of any clinically significant disease or clinically significant surgery within 4 weeks prior to enrollment
2) Hepatic, renal, or cardiac dysfunction requiring clinical treatment, or a history thereof
3) History of allergy to drugs or liposomal formulations
4) History of alcohol or drug dependence
5)Whole blood donation of >=400 mL within 4 months prior to screening, >=200 mL within 1 month prior to screening, or apheresis within 14 days prior to screening
6) Use of prescription or over-the-counter medications (including crude drugs) within 14 days prior to screening visit (excluding topical agents with no systemic exposure, such as disinfectants and ophthalmic solutions, that are considered not to affect the study)
7)Planned participation in another clinical study or post-marketing clinical study during the study period
8)Receipt of an investigational medicinal product in another clinical study within 4 months prior to screening (based on the last administration date)
9)Prior receipt of the investigational drug (NMU-HbV)
10) Clinically significant abnormal findings in vital signs or laboratory test results at screening that suggest a condition requiring treatment or organ dysfunction (unless the investigator or sub-investigator judges that participation in the study is acceptable)
11) Positive results for any of the following tests at screening: infectious disease tests (HBs antigen, syphilis tests [TP antibody (CLEIA) or RPR (LA)], HCV antibody, or HIV antibody) or urine drug screening
12)Women of childbearing potential who do not agree to use contraception* from the time of informed consent through the study period and until 12 weeks after the end of the study
*Definition of women of childbearing potential
Women from menarche to menopause are considered to have reproductive potential unless they have undergone permanent sterilization.
Women meeting any of the following criteria are not considered to be of childbearing potential
Pre-menarche
Documented hysterectomy
Documented bilateral salpingectomy
Documented bilateral oophorectomy
Postmenopausal (defined as at least 12 months since the last menstrual bleeding without an alternative medical cause)
13) Male subjects with a female partner of childbearing potential who do not agree that the subject or the partner will comply with contraception requirements, from the time of informed consent through the study period and until 12 weeks after the end of the study
14) Any other condition that, in the opinion of the principal investigator or sub-investigator, makes the subject unsuitable for participation in the study (e.g., anticipated difficulty in complying with study visits or subject management).
* Acceptable methods of contraception are medically appropriate methods (e.g., condoms, oral contraceptives)
<Exclusion Criteria at Pre-dose Assessment>
1) Participation in another clinical study and receipt of an investigational product between screening and admission
2) Use of any other medications within 14 days prior to admission
3)Receipt of medical treatment from a physician who is not involved in the study at the time of admission
4) Intake of food or beverages containing caffeine or alcohol within 3 days prior to initiation of investigational product administration
5) Any other condition that, in the opinion of the principal investigator or sub-investigator, makes the subject unsuitable for participation in the study (e.g., ineligibility based on pre-dose assessments, anticipated difficulty in complying with study visits or subject management)

Both

A condition requiring urgent blood transfusion

This is a single-center study conducted in healthy Japanese adults to evaluate the safety of NMU-HbV following intravenous administration
Cohort 1: 100 mL (maintenance infusion rate: 2.5 mL/min)
Cohort 2: 100 mL (maintenance infusion rate: 5.0 mL/min)
Cohort 3: 200 mL (maintenance infusion rate: 5.0 mL/min)
Cohort 4: 400 mL (maintenance infusion rate: 5.0 mL/min)
Cohorts will be initiated sequentially from Cohort 1. Progression to the next cohort will occur after completion of the observation period for the preceding cohort and review by the Safety Evaluation Committee

Safety
- Incidence and frequency of adverse events up to 14 days after investigational product administration
- Medically significant changes within 72 hours (3 days) after investigational product administration
Safety assessments will be based on subjective and objective symptoms, vital signs, electrocardiograms, and clinical laboratory test results compared with baseline (pre-dose) values

Pharmacokinetics
Plasma concentration-time profiles of NMU-HbV from immediately after administration through Day 15 will be evaluated.
The following pharmacokinetic parameters will be estimated:
- Maximum plasma concentration (Cmax)
- Time to reach maximum plasma concentration (Tmax)
- Area under the plasma concentration-time curve (AUC)
- Elimination half life (T1/2)

+81-744-22-3051

Dec. 10, 2024

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