A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of Kylo-11 in Healthy Subjects

This is a first-in-human, randomized, double-blind, placebo-controlled, single ascending dose study in healthy volunteers. Kylo-11 will be evaluated in approximately 60 subjects to assess safety, tolerability, pharmacokinetics and pharmacodynamic effects.

Start Date31 May 2024

Sponsor / Collaborator

Kylonova (Xiamen) Biopharma Co., Ltd.

CTR20241810 / RecruitingPhase 1

一项评价Kylo-11在中国成年健康受试者中单次给药剂量递增的安全性、耐受性、药代动力学和药效学的I期临床研究

[Translation] A Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of Kylo-11 in Chinese healthy adult subjects after single-dose escalation

主要研究目的：评估中国健康成年受试者接受Kylo-11单次给药后24周内的安全性、耐受性。次要研究目的：评估中国健康成年受试者接受Kylo-11单次给药后整个研究期间的安全性、耐受性。评估中国健康成年受试者接受Kylo-11单次给药后的药代动力学（PK）特征。评估中国健康成年受试者接受Kylo-11单次给药后的药效动力学（PD）特征。评估中国健康成年受试者接受Kylo-11单次给药后的免疫原性特征。探索性目的：初步探索Kylo-11单次给药后对脂蛋白（a）［Lp(a)］外其他血脂指标的影响。初步鉴定Kylo-11单次给药后的代谢产物。

[Translation]

Primary study objectives: To evaluate the safety and tolerability of Kylo-11 in healthy Chinese adult subjects within 24 weeks after a single dose. Secondary study objectives: To evaluate the safety and tolerability of Kylo-11 in healthy Chinese adult subjects throughout the study period after a single dose. To evaluate the pharmacokinetic (PK) characteristics of Kylo-11 in healthy Chinese adult subjects after a single dose. To evaluate the pharmacodynamic (PD) characteristics of Kylo-11 in healthy Chinese adult subjects after a single dose. To evaluate the immunogenicity characteristics of Kylo-11 in healthy Chinese adult subjects after a single dose. Exploratory objectives: To preliminarily explore the effects of a single dose of Kylo-11 on other lipid indicators besides lipoprotein (a) [Lp(a)]. To preliminarily identify the metabolites of Kylo-11 after a single dose.

Start Date20 May 2024

Sponsor / Collaborator

Kylonova (Xiamen) Biopharma Co., Ltd.

100 Clinical Results associated with Kylo-11

100 Translational Medicine associated with Kylo-11

100 Patents (Medical) associated with Kylo-11

100 Deals associated with Kylo-11

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Atherosclerosis	Phase 1	CN	Kylonova (Xiamen) Biopharma Co., Ltd.	20 May 2024
Lipoprotein (a) hyperlipoproteinemia	Phase 1	CN	Kylonova (Xiamen) Biopharma Co., Ltd.	20 May 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

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