A randomized, double-blind, placebo-controlled, single-dose and multiple-dose escalation phase I study evaluating the safety, tolerability, pharmacokinetic profile, and immunogenicity of PHP1003 in Chinese healthy adult subjects

Start Date18 Oct 2022

Sponsor / Collaborator-

CTR20222159

/ Active, not recruitingPhase 1

一项评价PHP1003在中国健康成年受试者中安全性、耐受性、药代动力学特征、免疫原性特征的随机、双盲、安慰剂对照、单次及多次剂量递增Ⅰ期临床研究

[Translation] A randomized, double-blind, placebo-controlled, single- and multiple-dose escalation Phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics, and immunogenicity of PHP1003 in healthy adult subjects in China

评价PHP1003在中国健康成年受试者中单次/多次，静脉滴注/皮下注射给药的安全性、耐受性和药代动力学特征。确定PHP1003在中国健康成年受试者中单次/多次，静脉滴注/皮下注射给药的最大耐受剂量（MTD），为后期临床试验给药方案提供安全的剂量范围。

[Translation]

Evaluate the safety, tolerability and pharmacokinetic characteristics of PHP1003 administered by single/multiple intravenous drip/subcutaneous injection in healthy Chinese adult subjects. Determine the maximum tolerated dose (MTD) of PHP1003 administered by single/multiple intravenous drip/subcutaneous injection in healthy Chinese adult subjects to provide a safe dose range for the dosing regimen of late-stage clinical trials.

Start Date18 Oct 2022

Sponsor / Collaborator

Suzhou Pulekang Pharmaceutical Technology Co., Ltd.

CTR20244055

/ Not yet recruitingPhase 2

一项评价PHP1003在治疗中国中重度甲状腺眼病（TED）患者中的有效性和安全性的多中心、随机、双盲、安慰剂对照的Ⅱ期临床研究

[Translation] A multicenter, randomized, double-blind, placebo-controlled Phase II clinical study to evaluate the efficacy and safety of PHP1003 in the treatment of moderate to severe thyroid eye disease (TED) in Chinese patients

基于眼球突出应答率评价PHP1003在中国TED患者中的初步疗效

[Translation]

Evaluation of the preliminary efficacy of PHP1003 in Chinese TED patients based on proptosis response rate

Start Date-

Sponsor / Collaborator

Suzhou Pulekang Pharmaceutical Technology Co., Ltd.

100 Clinical Results associated with PHP1003

100 Translational Medicine associated with PHP1003

100 Patents (Medical) associated with PHP1003

100 Deals associated with PHP1003

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Graves Ophthalmopathy	Phase 2	China	Suzhou Pulekang Pharmaceutical Technology Co., Ltd.	06 Nov 2024

Clinical Result

Indication

Phase

Evaluation

View All Results

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis