PMID- 37535074
OWN - NLM
STAT- MEDLINE
DCOM- 20240117
LR  - 20240122
IS  - 1432-1912 (Electronic)
IS  - 0028-1298 (Linking)
VI  - 397
IP  - 2
DP  - 2024 Feb
TI  - Comparison of pharmacokinetics and safety of albuvirtide in healthy subjects 
      after intravenous drip and bolus injection.
PG  - 913-922
LID - 10.1007/s00210-023-02614-2 [doi]
AB  - Albuvirtide (ABT) is the first long-acting HIV fusion inhibitor developed in 
      China, blocking the invasion of HIV-1 virus into target cells. This study aimed 
      to compare the pharmacokinetics (PK), tolerability, and safety of ABT following a 
      single intravenous (IV) bolus injection or intravenous drip in healthy Chinese 
      subjects. A single-center, randomized, open-label, single-period, parallel phase 
      I clinical trial was conducted. Thirty subjects were randomly divided into three 
      groups in a ratio of 1:1:1. After an overnight fast, all subjects received a 
      single dose of 320 mg ABT either by intravenous drip for 45 min (group A) or 
      bolus injection for 0.5 min (group B), or bolus injection for 3 min (group C). 
      ABT plasma concentrations were analyzed using a validated enzyme-linked 
      immunosorbent assay (ELISA). Non-compartmental analysis was used to evaluate PK 
      parameters. The median time to reach maximum concentration was 0.75 h in group A 
      and 0.16 h in both groups B and C. Elimination half-life, mean residence time, 
      apparent clearance, and apparent volume of distribution were similar among the 
      three groups. The 90% confidence intervals (CI) of geometric mean ratios of PK 
      parameters for groups B and C relative to group C were within 85-120%. All 
      adverse events (AEs) reported in this study were mild, according to the CTCAE 
      guidelines and the study investigator's judgement. ABT bolus injections for 
      0.5 min and 3 min are expected to be well tolerated and to exhibit similar PK 
      characteristics as IV drip for 45 min, offering potential clinical benefits.
CI  - (c) 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, 
      part of Springer Nature.
FAU - Qin, Huiling
AU  - Qin H
AD  - Department of Clinical Pharmacology, The Second Affiliated Hospital of Anhui 
      Medical University, Hefei, 230601, Anhui, China.
FAU - Yao, Cheng
AU  - Yao C
AD  - Frontier Biotechnologies Inc, Nanjing, 211122, Jiangsu, China.
FAU - Zhang, Wei
AU  - Zhang W
AD  - Department of Clinical Pharmacology, The Second Affiliated Hospital of Anhui 
      Medical University, Hefei, 230601, Anhui, China.
FAU - Hu, Wei
AU  - Hu W
AD  - Department of Clinical Pharmacology, The Second Affiliated Hospital of Anhui 
      Medical University, Hefei, 230601, Anhui, China.
FAU - Liu, Yuantao
AU  - Liu Y
AD  - Frontier Biotechnologies Inc, Nanjing, 211122, Jiangsu, China.
FAU - Yu, Shuchang
AU  - Yu S
AD  - Frontier Biotechnologies Inc, Nanjing, 211122, Jiangsu, China.
FAU - Xie, Dong
AU  - Xie D
AD  - Frontier Biotechnologies Inc, Nanjing, 211122, Jiangsu, China.
FAU - Hu, Min
AU  - Hu M
AD  - Frontier Biotechnologies Inc, Nanjing, 211122, Jiangsu, China. 
      mhu@frontierbiotech.com.
FAU - Ye, Jun
AU  - Ye J
AD  - Department of Infectious Diseases, The Second Affiliated Hospital of Anhui 
      Medical University, Hefei, 230601, Anhui, China. yejun2004088@126.com.
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20230803
PL  - Germany
TA  - Naunyn Schmiedebergs Arch Pharmacol
JT  - Naunyn-Schmiedeberg's archives of pharmacology
JID - 0326264
RN  - MG9PC54E43 (albuvirtide)
RN  - 0 (Peptides)
RN  - 0 (Maleimides)
SB  - IM
MH  - Humans
MH  - Infusions, Intravenous
MH  - Healthy Volunteers
MH  - *Peptides
MH  - Injections, Intravenous
MH  - *Maleimides
OTO - NOTNLM
OT  - Albuvirtide
OT  - Bioequivalence
OT  - Bolus injection
OT  - Pharmacokinetics
EDAT- 2023/08/03 13:09
MHDA- 2024/01/17 06:42
CRDT- 2023/08/03 11:03
PHST- 2023/04/19 00:00 [received]
PHST- 2023/07/06 00:00 [accepted]
PHST- 2024/01/17 06:42 [medline]
PHST- 2023/08/03 13:09 [pubmed]
PHST- 2023/08/03 11:03 [entrez]
AID - 10.1007/s00210-023-02614-2 [pii]
AID - 10.1007/s00210-023-02614-2 [doi]
PST - ppublish
SO  - Naunyn Schmiedebergs Arch Pharmacol. 2024 Feb;397(2):913-922. doi: 
      10.1007/s00210-023-02614-2. Epub 2023 Aug 3.