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The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Subcutaneous Administration of a Novel Anti-NGF Monoclonal Antibody (AK115) in Healthy Participants: A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Phase I Clinical Trial.

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Title: The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Subcutaneous Administration of a Novel Anti-NGF Monoclonal Antibody (AK115) in Healthy Participants: A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Phase I Clinical Trial.
Authors: Zhang J; Research Center of Clinical Pharmacology, the First Affiliated Hospital of Yunnan University of Chinese Medicine, Yunnan, People's Republic of China.; Research Center for Early Clinical Trials of Drugs (Vaccines), the Affiliated Anning First People's Hospital, Kunming University of Science and Technology, Kunming, People's Republic of China., Fan YX; Research Center of Clinical Pharmacology, the First Affiliated Hospital of Yunnan University of Chinese Medicine, Yunnan, People's Republic of China., Huang Y; Research Center of Clinical Pharmacology, the First Affiliated Hospital of Yunnan University of Chinese Medicine, Yunnan, People's Republic of China., Guan R; Research Center of Clinical Pharmacology, the First Affiliated Hospital of Yunnan University of Chinese Medicine, Yunnan, People's Republic of China., Li R; Research Center of Clinical Pharmacology, the First Affiliated Hospital of Yunnan University of Chinese Medicine, Yunnan, People's Republic of China., Long S; Research Center of Clinical Pharmacology, the First Affiliated Hospital of Yunnan University of Chinese Medicine, Yunnan, People's Republic of China., Yang M; Research Center of Clinical Pharmacology, the First Affiliated Hospital of Yunnan University of Chinese Medicine, Yunnan, People's Republic of China., Yu B; Akeso Biopharma, Inc, Zhongshan, People's Republic of China., Wang GQ; Akeso Biopharma, Inc, Zhongshan, People's Republic of China., Chen P; Akeso Biopharma, Inc, Zhongshan, People's Republic of China., Gong X; Akeso Biopharma, Inc, Zhongshan, People's Republic of China., Li B; Akeso Biopharma, Inc, Zhongshan, People's Republic of China., Xia M; Akeso Biopharma, Inc, Zhongshan, People's Republic of China., He J; Research Center of Clinical Pharmacology, the First Affiliated Hospital of Yunnan University of Chinese Medicine, Yunnan, People's Republic of China.
Source: Drug design, development and therapy [Drug Des Devel Ther] 2025 Apr 24; Vol. 19, pp. 3225-3235. Date of Electronic Publication: 2025 Apr 24 (Print Publication: 2025).
Publication Type: Journal Article; Randomized Controlled Trial; Clinical Trial, Phase I
Journal Info: Publisher: Dove Press Limited Country of Publication: New Zealand NLM ID: 101475745 Publication Model: eCollection Cited Medium: Internet ISSN: 1177-8881 (Electronic) Linking ISSN: 11778881 NLM ISO Abbreviation: Drug Des Devel Ther Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Subcutaneous Administration of a Novel Anti-NGF Monoclonal Antibody (AK115) in Healthy Participants: A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Phase I Clinical Trial.
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  Data: <searchLink fieldCode="AU" term="%22Zhang+J%22">Zhang J</searchLink>; Research Center of Clinical Pharmacology, the First Affiliated Hospital of Yunnan University of Chinese Medicine, Yunnan, People's Republic of China.; Research Center for Early Clinical Trials of Drugs (Vaccines), the Affiliated Anning First People's Hospital, Kunming University of Science and Technology, Kunming, People's Republic of China.<br /><searchLink fieldCode="AU" term="%22Fan+YX%22">Fan YX</searchLink>; Research Center of Clinical Pharmacology, the First Affiliated Hospital of Yunnan University of Chinese Medicine, Yunnan, People's Republic of China.<br /><searchLink fieldCode="AU" term="%22Huang+Y%22">Huang Y</searchLink>; Research Center of Clinical Pharmacology, the First Affiliated Hospital of Yunnan University of Chinese Medicine, Yunnan, People's Republic of China.<br /><searchLink fieldCode="AU" term="%22Guan+R%22">Guan R</searchLink>; Research Center of Clinical Pharmacology, the First Affiliated Hospital of Yunnan University of Chinese Medicine, Yunnan, People's Republic of China.<br /><searchLink fieldCode="AU" term="%22Li+R%22">Li R</searchLink>; Research Center of Clinical Pharmacology, the First Affiliated Hospital of Yunnan University of Chinese Medicine, Yunnan, People's Republic of China.<br /><searchLink fieldCode="AU" term="%22Long+S%22">Long S</searchLink>; Research Center of Clinical Pharmacology, the First Affiliated Hospital of Yunnan University of Chinese Medicine, Yunnan, People's Republic of China.<br /><searchLink fieldCode="AU" term="%22Yang+M%22">Yang M</searchLink>; Research Center of Clinical Pharmacology, the First Affiliated Hospital of Yunnan University of Chinese Medicine, Yunnan, People's Republic of China.<br /><searchLink fieldCode="AU" term="%22Yu+B%22">Yu B</searchLink>; Akeso Biopharma, Inc, Zhongshan, People's Republic of China.<br /><searchLink fieldCode="AU" term="%22Wang+GQ%22">Wang GQ</searchLink>; Akeso Biopharma, Inc, Zhongshan, People's Republic of China.<br /><searchLink fieldCode="AU" term="%22Chen+P%22">Chen P</searchLink>; Akeso Biopharma, Inc, Zhongshan, People's Republic of China.<br /><searchLink fieldCode="AU" term="%22Gong+X%22">Gong X</searchLink>; Akeso Biopharma, Inc, Zhongshan, People's Republic of China.<br /><searchLink fieldCode="AU" term="%22Li+B%22">Li B</searchLink>; Akeso Biopharma, Inc, Zhongshan, People's Republic of China.<br /><searchLink fieldCode="AU" term="%22Xia+M%22">Xia M</searchLink>; Akeso Biopharma, Inc, Zhongshan, People's Republic of China.<br /><searchLink fieldCode="AU" term="%22He+J%22">He J</searchLink>; Research Center of Clinical Pharmacology, the First Affiliated Hospital of Yunnan University of Chinese Medicine, Yunnan, People's Republic of China.
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