[Translation] A Phase I clinical study to evaluate the safety, tolerability and pharmacokinetics of AP017 monoclonal antibody injection in healthy subjects in a randomized, double-blind, placebo-controlled, single-dose escalation

主要目的评价健康受试者单次注射不同剂量AP017单克隆抗体注射液的安全性和耐受性。次要目的 1）评价健康受试者单次注射不同剂量AP017单克隆抗体注射液的药代动力学特征； 2）评价健康受试者单次注射不同剂量AP017单克隆抗体注射液的免疫原性； 3）评价健康受试者单次注射不同剂量AP017单克隆抗体注射液的药效学特征。探索性目的探索健康受试者单次注射不同剂量AP017单克隆抗体注射液的PK/PD相关性。

[Translation]

Primary objective To evaluate the safety and tolerability of a single injection of different doses of AP017 monoclonal antibody injection in healthy subjects. Secondary objectives 1) To evaluate the pharmacokinetic characteristics of a single injection of different doses of AP017 monoclonal antibody injection in healthy subjects; 2) To evaluate the immunogenicity of a single injection of different doses of AP017 monoclonal antibody injection in healthy subjects; 3) To evaluate the pharmacodynamic characteristics of a single injection of different doses of AP017 monoclonal antibody injection in healthy subjects. Exploratory objective To explore the PK/PD correlation of a single injection of different doses of AP017 monoclonal antibody injection in healthy subjects.

Start Date10 Jul 2023

Sponsor / Collaborator

Anyuan Pharmaceutical Technology (Shanghai) Co., Ltd.

100 Clinical Results associated with AP017

100 Translational Medicine associated with AP017

100 Patents (Medical) associated with AP017

Literatures (Medical) associated with AP017

01 Nov 2022·World Neurosurgery

Safety and Efficacy of the Novel Low-Profile APERIO Hybrid17 for a Treatment of Proximal and Distal Vessel Occlusion in Acute Ischemic Stroke: A Multi-Center Experience

Article

Author: Weiss, Daniel ; Phung, Timo Huan ; Goertz, Lukas ; Schlamann, Marc ; Dorn, Franziska ; Kaschner, Marius ; Borggrefe, Jan ; Haage, Patrick ; Nordmeyer, Hannes ; Moenninghoff, Christoph ; Abdullayev, Nuran ; Kabbasch, Christoph

OBJECTIVETo report our initial experience with the novel low-profile APERIO Hybrid¹⁷ Thrombectomy Device (AP17) for proximal and distal vessel occlusions in acute ischemic stroke.METHODSA multicentric retrospective analysis of patients treated with the AP17 was performed. The primary effectiveness endpoint was first-pass TICI ≥2b (Thrombolysis in cerebral infarction scale). The primary safety endpoint was the occurrence of hemorrhagic complications. Further outcome measures were number of passes, device-related complications, and 3-month functional outcome.RESULTSThe AP17 was used in 71 patients (mean age: 73 years) with a median baseline National Institutes of Health Stroke Scale score of 9. Treated vessels were the carotid-T in 8 cases (11%), the M1-segment in 16 (23%), the M2-segment in 29 (41%), the anterior cerebral artery in 3 (4%), and basilar/posterior cerebral arteries in 15 (21%). The rates of first-pass and final TICI ≥2b were 75.6% and 92.7%, retrospectively, with a mean number of passes of 3 ± 2. Final TICI ≥2b rates were comparable between large and medium vessel occlusions. Symptomatic intracranial hemorrhages were recorded in 2 cases (2.8%). At 3-month clinical follow-up, a modified Rankin scale score ≤2 was achieved in 69.0% (29/42). The all-cause mortality at discharge was 17.4%.CONCLUSIONSThe AP17 was associated with a reasonable safety and efficacy profile for both proximal and distal vessel occlusions. These results may contribute to establish mechanical thrombectomy for distal occlusions.

29 Oct 2020·Microbiology Resource Announcements

Whole-Genome Sequence of Cyanobacterium Oxynema sp. AP17, Isolated from an Indian Mangrove Forest

Article

Author: Mukherjee, Joydeep ; Pramanik, Arnab ; Maruthanayagam, Veerabadhran ; Basu, Shayontani

01 Jun 1987·Applied and Environmental MicrobiologyQ2 · BIOLOGY

Comparative survival of antibiotic-resistant and -sensitive fecal indicator bacteria in estuarine water

Q2 · BIOLOGY

Article

Author: Sullivan, S A ; Shiaris, M P ; Pettibone, G W

The survival of antibiotic-resistant and -sensitive strains of Escherichia coli, Enterococcus faecalis, Enterococcus faecium, Streptococcus equinus, and two environmental isolates, AP17 and AQ62, was examined in estuarine water. Each strain was rendered resistant to a combination of two antibiotics by serial passage in increasing concentrations of antibiotics. Cultures were incubated in filter-sterilized estuarine water for up to 7 days. Recovery was assessed by examining colony-forming ability on media with and without antibiotics. None of the antibiotic-resistant forms survived longer than its antibiotic-sensitive counterpart in estuarine water. Three of the resistant strains died off more rapidly than the antibiotic-sensitive wild type. Survival of the test bacteria in estuarine water was as follows: sensitive and resistant AQ62, resistant Escherichia coli less than sensitive Escherichia coli less than resistant AP17 less than resistant Enterococcus faecium less than sensitive AP17, sensitive and resistant S. equinus less than sensitive and resistant Enterococcus faecalis, sensitive Enterococcus faecium. The results supported the suggestion that fecal entercocci may serve as better indicators of fecal pollution than Escherichia coli in marine ecosystems. Moreover, the results indicated that the use of antibiotic-resistant mutants to follow the fate of bacteria in the environment is inappropriate without adequate studies to ensure that resistant and wild-type strains react similarly to environmental stressors.

100 Deals associated with AP017

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Hemophilia A	Phase 1	CN	Anyuan Pharmaceutical Technology (Shanghai) Co., Ltd.	10 Jul 2023
Hemophilia B	Phase 1	CN	Anyuan Pharmaceutical Technology (Shanghai) Co., Ltd.	10 Jul 2023

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