Oct. 13, 2020 |
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Dec. 19, 2022 |
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jRCT2011200004 |
Phase I study of intravenous administration of NMU-HbV as a red blood cell substitute to healthy adult male volunteers (HbV-101) |
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Phase I study of NMU-HbV as a red blood cell substitute (HbV-101) |
Aug. 20, 2021 |
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11 |
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The participant is a healthy Japanese adult male |
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Twelve subjects were enrolled. This trial consisted of cohort 1 (10 ml infusion), cohort 2 (50 ml infusion) and cohort 3 (premedication followed by 100 ml infusion). 4 subjects were enrolled in each cohort. In cohort 1 and 2, all subjects completed infusion as scheduled. The initiation of cohort 3 was delayed due to the wide spread of coronavirus infection. For the first 2 subjects, a 100 ml infusion was completed. For the 3rd subject, the infusion was halted after approximately 10 ml was infused because of the appearance of rash. The infusion to the 4th subject was cancelled because the investigational drug prepared for this study had expired. (October 2020~September 2021) |
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There was no serious adverse event or death. In cohort 1, three subjects experienced transient infusion reaction (Burning sensation, Flushing, Head dullness, Fatigue, Dizziness, Feeling of strangulation) and slight fever. In cohort 2, two subjects experienced slight fever and 1 subject manifested congestion of conjunctiva. In cohort 3, assigning top priority to subject safety, premedication (dexamethasone, acetaminophen, famotidine) was introduced. In one subject, sense of discomfort in the lower back and manifestation of skin rash was observed. All adverse events resolved spontaneously without medication. |
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Safety: No serious adverse event or death was observed. Infusion reactions, slight fever and skin rash were observed. However, all these events soon resolved spontaneously. For vital signs and hematological and biochemical test, no clinically significant deviation was observed. Pharmacokinetics: Analysis of pharmacokinetics was conducted in 2 subject in cohort 3. The results showed AUCt: 4030, 4700 mg hr/dL, Cmax; 280, 300 mg/dL, T1/2; 7.5, 8.9 hr |
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Adverse events including infusion reactions were transient and tolerable and resolved spontaneously. Vital sign, hematological and biochemical test revealed no clinically significant deviation. The half-life of this drug in the blood at 100 ml infusion was approximately 8 hours, demonstrating that this drug can stay in bloodstream several hours. Based on these results, a plan to conduct Phase 2 trial is being prepared. |
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Dec. 14, 2022 |
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Aug. 08, 2022 |
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https://ashpublications.org/bloodadvances/article/6/21/5711/486139/First-in-human-phase-1-trial-of-hemoglobin |
No |
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https://jrct.niph.go.jp/latest-detail/jRCT2011200004 |
Amano Toraji |
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Hokkaido Univ. |
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Kita 14 Nishi 5, Kita-ku, Sapporo, Hokkaido |
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+81-11-716-1161 |
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n-kami@asahikawa-med.ac.jp |
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Azuma Hiroshi |
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Asahikawa Medical Univ. |
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Midorigaokahigashi 2-1-1-1, Asahikawa, Hokkaido |
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+81-166-68-2481 |
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n-kami@asahikawa-med.ac.jp |
Complete |
Oct. 19, 2020 |
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Oct. 19, 2020 | ||
12 | ||
Interventional |
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single arm study |
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open(masking not used) |
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uncontrolled control |
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single assignment |
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treatment purpose |
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1) The participant is a healthy Japanese adult male |
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1) The participant who have a clinically relevant history or current treatment with surgical operation within 4 weeks before registration. |
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20age old over | ||
50age old under | ||
Male |
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Urgent need for blood transfusion |
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A single-center study designed to evaluate the safety of NMU-HbV administered intravenously to healthy adult males in Japan. |
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Safety |
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Pharmacokinetics |
AMED | |
Not applicable |
Hokkaido University Hospital Institutional Review Board | |
Kita 14 Nishi 5, Kita-ku, Sapporo, Hokkaido | |
+81-117161161 |
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tiken@med.hokudai.ac.jp | |
Approval | |
Aug. 03, 2020 |
none |