[Translation] A Phase Ib/II clinical trial to evaluate the safety, pharmacokinetics, immunogenicity and preliminary efficacy of EP-9001A injection in the treatment of moderate to severe bone metastasis cancer pain.

主要目的：评价EP-9001A注射液在骨转移癌痛患者中的安全性和耐受性。次要目的： 1)评价EP-9001A注射液在骨转移癌痛患者中的药代动力学特征； 2)评价EP-9001A注射液在骨转移癌痛患者中的免疫原性； 3)评价EP-9001A注射液在骨转移癌痛患者中的初步有效性。

[Translation]

Primary purpose: To evaluate the safety and tolerability of EP-9001A injection in patients with bone metastasis cancer pain. Secondary purposes: 1) To evaluate the pharmacokinetic characteristics of EP-9001A injection in patients with bone metastasis cancer pain; 2) To evaluate the immunogenicity of EP-9001A injection in patients with bone metastasis cancer pain; 3) To evaluate the preliminary efficacy of EP-9001A injection in patients with bone metastasis cancer pain.

Start Date30 Oct 2023

Sponsor / Collaborator

Chengdu Youluo Biotechnology Co., Ltd.

CTR20220481

/ CompletedPhase 1

评估EP-9001A注射液在健康受试者中的安全性、耐受性、药代动力学以及免疫原性的随机、双盲、安慰剂对照剂量爬坡Ia期临床试验。

[Translation] A randomized, double-blind, placebo-controlled, dose-escalation Phase Ia clinical trial to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of EP-9001A injection in healthy subjects.

主要目的：评价EP-9001A注射液在健康受试者中的安全性和耐受性。次要目的：1) 评价EP-9001A注射液在健康受试者中的药代动力学特征；2) 评价EP-9001A注射液在健康受试者中的免疫原性。

[Translation]

Primary objective: To evaluate the safety and tolerability of EP-9001A injection in healthy subjects. Secondary objectives: 1) To evaluate the pharmacokinetic characteristics of EP-9001A injection in healthy subjects; 2) To evaluate the immunogenicity of EP-9001A injection in healthy subjects.

Start Date10 May 2022

Sponsor / Collaborator

Chengdu Youluo Biotechnology Co., Ltd.

NCT05278611

/ Unknown statusPhase 1

A Randomized, Double-blind, Placebo-controlled Dose Escalation Phase Ia Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of EP-9001A Injection in Healthy Subjects

Nerve Growth Factor（NGF）plays an important role in the pathogenesis of neuropathic pain including cancer pain. EP-9001A is a humanized monoclonal antibody targeting NGF, thus thought to alleviate neuropathic pain though the blockade of NGF signal pathway.
The primary objective of the study is to assess the safety and tolerability of a single dose of subcutaneous (SC) administered EP-9001A in healthy Chinese subjects.

Start Date23 Mar 2022

Sponsor / Collaborator

Chengdu Easton Biopharmaceuticals Co., Ltd.

100 Clinical Results associated with EP-9001A

100 Translational Medicine associated with EP-9001A

100 Patents (Medical) associated with EP-9001A

100 Deals associated with EP-9001A

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Cancer Pain	Phase 2	China	Chengdu Youluo Biotechnology Co., Ltd.	30 Oct 2023
Neuralgia	Discovery	China	Chengdu Easton Biopharmaceuticals Co., Ltd.	23 Mar 2022

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