[Translation] A randomized, double-blind, placebo-controlled phase II clinical study to preliminarily evaluate the efficacy and safety of STC007 injection in the treatment of chronic kidney disease-related pruritus in patients undergoing hemodialysis

主要目的：评价不同剂量STC007注射液连续给药12周在接受血液透析的中至重度慢性肾脏病相关性瘙痒患者中的初步有效性，探索可能的Ⅲ期给药剂量。次要目的：初步评价不同剂量STC007注射液连续给药12周在接受血液透析的中至重度慢性肾脏病相关性瘙痒患者中的安全性。探索性评价不同剂量STC007注射液连续给药12周后停药1周在接受血液透析的中至重度慢性肾脏病相关性瘙痒患者中的躯体依赖性。

[Translation]

Primary purpose: To evaluate the preliminary efficacy of different doses of STC007 injection for 12 weeks in patients with moderate to severe chronic kidney disease-related pruritus undergoing hemodialysis, and to explore possible Phase III dosing doses. Secondary purpose: Preliminary evaluation of the safety of different doses of STC007 injection for 12 weeks in patients with moderate to severe chronic kidney disease-related pruritus undergoing hemodialysis. Exploratory evaluation of the physical dependence of different doses of STC007 injection for 12 weeks followed by 1 week of discontinuation in patients with moderate to severe chronic kidney disease-related pruritus undergoing hemodialysis.

Start Date03 Apr 2026

Sponsor / Collaborator

Chengdu Nuohe Shengtai Biotechnology Co., Ltd.

CTR20241332

/ CompletedPhase 2

初步评估 STC007 注射液治疗腹部手术后疼痛的有效性、安全性和药代动力学特征的随机、双盲、安慰剂/阳性对照Ⅱ期临床研究

[Translation] A randomized, double-blind, placebo/active-controlled Phase II clinical study to preliminarily evaluate the efficacy, safety and pharmacokinetic characteristics of STC007 injection in the treatment of postoperative pain in abdominal surgery

与安慰剂和阳性对照药比较，初步评价STC007注射液不同剂量下治疗腹部手术后疼痛的有效性，探索STC007注射液用于腹部术后镇痛的合理剂量。

[Translation]

Compared with placebo and positive control drugs, the effectiveness of STC007 injection at different doses in treating pain after abdominal surgery was preliminarily evaluated, and the reasonable dose of STC007 injection for abdominal postoperative analgesia was explored.

Start Date28 Oct 2024

Sponsor / Collaborator

Chengdu Nuohe Shengtai Biotechnology Co., Ltd.

CTR20240648

/ CompletedPhase 1

评估STC007注射液在接受血液透析的中至重度慢性肾病相关性瘙痒患者中多次给药的安全性、耐受性、PK及PD特征的Ib期临床研究

[Translation] A Phase Ib clinical study to evaluate the safety, tolerability, PK and PD characteristics of STC007 injection after multiple doses in patients with moderate to severe chronic kidney disease-related pruritus undergoing hemodialysis

主要目的：与同等剂量KAPRUVIA™（difelikefalin）注射液比较，评估一周内多次给予0.5μg/kg STC007注射液在接受血液透析的中至重度慢性肾脏病相关性瘙痒患者中的PK及PD特征。次要目的：评价一周内多次给予0.5μg/kg STC007注射液在接受血液透析的中至重度慢性肾脏病相关性瘙痒患者中的安全性、耐受性。

[Translation]

Primary objective: Compared with the same dose of KAPRUVIA™ (difelikefalin) injection, evaluate the PK and PD characteristics of 0.5μg/kg STC007 injection given multiple times a week in patients with moderate to severe chronic kidney disease-related pruritus undergoing hemodialysis. Secondary objective: Evaluate the safety and tolerability of 0.5μg/kg STC007 injection given multiple times a week in patients with moderate to severe chronic kidney disease-related pruritus undergoing hemodialysis.

Start Date10 Apr 2024

Sponsor / Collaborator

Chengdu Nuohe Shengtai Biotechnology Co., Ltd.

100 Clinical Results associated with STC007

100 Translational Medicine associated with STC007

100 Patents (Medical) associated with STC007

100 Deals associated with STC007

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Chronic Kidney Disease-Associated Pruritus	Phase 2	China	Chengdu Nuohe Shengtai Biotechnology Co., Ltd.	03 Apr 2026
Pain, Postoperative	Phase 2	China	Chengdu Nuohe Shengtai Biotechnology Co., Ltd.	28 Oct 2024
Chronic Kidney Diseases	Phase 1	China	Chengdu Nuohe Shengtai Biotechnology Co., Ltd.	17 May 2023

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