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MechanismAPOC3 inhibitors |
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Inactive Indication- |
Drug Highest PhasePhase 1 |
First Approval Ctry. / Loc.- |
First Approval Date- |
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Mechanismlipoprotein(a) inhibitors |
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Inactive Indication- |
Drug Highest PhasePhase 1 |
First Approval Ctry. / Loc.- |
First Approval Date- |
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Inactive Indication- |
Drug Highest PhasePhase 1 |
First Approval Ctry. / Loc.- |
First Approval Date- |
一项评价Kylo-12在中国健康成年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-12 in healthy Chinese 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-12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-12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-12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-12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-12单次给药后的免疫原性特征。
探索性目的：
初步探索Kylo-12单次给药后对除载脂蛋白C3（ApoC3）、甘油三酯（TG）外其他血脂指标和其他探索性指标的影响。
初步鉴定Kylo-12单次给药后的代谢产物。
[Translation] Main study objectives:
To evaluate the safety and tolerability of Kylo-12 in healthy Chinese adult subjects within 24 weeks after a single dose.
Secondary study objectives:
To evaluate the safety and tolerability of Kylo-12 in healthy Chinese adult subjects throughout the study period after a single dose.
To evaluate the pharmacokinetic (PK) characteristics of Kylo-12 in healthy Chinese adult subjects after a single dose.
To evaluate the pharmacodynamic (PD) characteristics of Kylo-12 in healthy Chinese adult subjects after a single dose.
To evaluate the immunogenicity characteristics of Kylo-12 in healthy Chinese adult subjects after a single dose.
Exploratory objectives:
To preliminarily explore the effects of a single dose of Kylo-12 on other lipid indicators and other exploratory indicators except apolipoprotein C3 (ApoC3) and triglycerides (TG).
To preliminarily identify the metabolites of Kylo-12 after a single dose.
/ Not yet recruitingPhase 1 A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of Kylo-12 in Healthy Subjects
This is a first-in-human, randomized, double-blind, placebo-controlled, single ascending dose study in healthy volunteers. Kylo-12 will be evaluated in approximately 50 subjects to assess safety, tolerability, pharmacokinetics and pharmacodynamic effects.
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.
100 Clinical Results associated with Kylonova (Xiamen) Biopharma Co., Ltd.
0 Patents (Medical) associated with Kylonova (Xiamen) Biopharma Co., Ltd.
100 Deals associated with Kylonova (Xiamen) Biopharma Co., Ltd.
100 Translational Medicine associated with Kylonova (Xiamen) Biopharma Co., Ltd.
