Delving into the Latest Updates on PTT-621 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

PTT-621

Target

ALPK1

Action

inhibitors

Mechanism

ALPK1 inhibitors(alpha kinase 1 inhibitors)

Therapeutic Areas

Immune System DiseasesDigestive System Disorders

Active Indication

Colitis, Ulcerative

Inactive Indication-

Originator Organization

Pyrotech Therapeutics, Inc.

Active Organization

Pyrotech Therapeutics, Inc.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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主要目的：评价PTT-621在健康受试者中单、多次不同剂量给药后的安全性和耐受性。次要目的：评价PTT-621在健康受试者中单、多次不同剂量给药后的药代动力学（Pharmacokinetics，PK）特征。探索性目的：1）探索PTT-621在健康受试者中单、多次不同剂量给药后体内生物标志物浓度变化特征；2）评价PTT-621在健康受试者中单次不同剂量给药后的血药浓度对QTc间期的影响（C-QTc研究）；3）探索食物对PTT-621药代动力学特征的影响。

[Translation]

Primary objective: To evaluate the safety and tolerability of PTT-621 after single and multiple administrations of different doses in healthy subjects. Secondary objective: To evaluate the pharmacokinetic (PK) characteristics of PTT-621 after single and multiple administrations of different doses in healthy subjects. Exploratory objectives: 1) To explore the characteristics of changes in biomarker concentrations in vivo after single and multiple administrations of different doses of PTT-621 in healthy subjects; 2) To evaluate the effect of blood drug concentrations of PTT-621 on the QTc interval after single and multiple administrations of different doses in healthy subjects (C-QTc study); 3) To explore the effect of food on the pharmacokinetic characteristics of PTT-621.

Start Date24 Jul 2025

Sponsor / Collaborator

Pyrotech Therapeutics, Inc.

ChiCTR2500110503

/ RecruitingPhase 1IIT

A single-center, randomized, double-blind, placebo-controlled phase I clinical study to evaluate the safety, tolerability and pharmacokinetic characteristics of single and multiple dosing of PTT-621 in healthy patients

Start Date20 Jun 2025

Sponsor / Collaborator

Peking University Third Hospital

[+1]

CTR20262689

/ Not yet recruitingPhase 2

一项评估PTT-621在中重度活动性溃疡性结肠炎患者中的疗效、安全性、耐受性和药代动力学特征的IIa期、多中心、单臂研究

[Translation] A phase IIa, multicenter, single-arm study evaluating the efficacy, safety, tolerability, and pharmacokinetic characteristics of PTT-621 in patients with moderate to severe active ulcerative colitis.

主要目的： 1. 评估PTT-621在中重度活动性溃疡性结肠炎患者中的有效性（内镜改善）次要目的： 1. 评估PTT-621在中重度活动性溃疡性结肠炎患者中的安全性和耐受性 2. 评估PTT-621在中重度活动性溃疡性结肠炎患者中的有效性（临床缓解） 3. 评估PTT-621在中重度活动性溃疡性结肠炎患者中的其他有效性 4. 评估PTT-621和代谢产物（如可能）在中重度活动性溃疡性结肠炎患者中的药代动力学（PK）特征 5. 评估PTT-621对中重度活动性溃疡性结肠炎患者粪便钙卫蛋白和高敏C反应蛋白（hsCRP）的影响探索性目的： 1. 探索PTT-621对中重度活动性溃疡性结肠炎患者组织学的影响 2. 探索药效学生物标志物特征（可选）

[Translation]

Primary Objectives: 1. To evaluate the efficacy of PTT-621 in patients with moderate to severe active ulcerative colitis (endoscopic improvement). Secondary Objectives: 1. To evaluate the safety and tolerability of PTT-621 in patients with moderate to severe active ulcerative colitis. 2. To evaluate the efficacy of PTT-621 in patients with moderate to severe active ulcerative colitis (clinical remission). 3. To evaluate other efficacy of PTT-621 in patients with moderate to severe active ulcerative colitis. 4. To evaluate the pharmacokinetic (PK) characteristics of PTT-621 and its metabolites (if possible) in patients with moderate to severe active ulcerative colitis. 5. To evaluate the effects of PTT-621 on fecal calprotectin and high-sensitivity C-reactive protein (hsCRP) in patients with moderate to severe active ulcerative colitis. Exploratory Objectives: 1. To explore the histological effects of PTT-621 on patients with moderate to severe active ulcerative colitis. 2. To explore pharmacodynamic biomarker characterization (optional).

Start Date-

Sponsor / Collaborator

Pyrotech Therapeutics, Inc.

100 Clinical Results associated with PTT-621

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100 Translational Medicine associated with PTT-621

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100 Patents (Medical) associated with PTT-621

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100 Deals associated with PTT-621

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