A Phase 1b/2a Multicenter Study to Assess the Safety and Tolerability, Pharmacokinetics, and Preliminary Efficacy of KPG-818 in Patients With Systemic Lupus Erythematosus
Abstract
The clinical trial is titled "A Phase 1b/2a Multicenter Study to Assess the Safety and Tolerability, Pharmacokinetics, and Preliminary Efficacy of KPG-818 in Patients with Systemic Lupus Erythematosus". This study was designed to address the following key questions:
* Phase 1b: Assess safety and PK of KPG-818 in SLE patients over 14 days.
* Phase 2a: Assess safety, efficacy, PD biomarkers, and PK of KPG-818 in SLE patients over 12 weeks.
The study design comprises eight Cohorts, which are outlined below:
* Phase 1b dose levels: Cohort A (0.15 mg/day), B (0.6 mg/day), C (2 mg/day), and D (5 mg/day).
* Phase 2a dose levels: Cohort E (0.15 mg/day), F (0.6 mg/day), G (2 mg/day) and H (placebo).
Conditions: SLE; Drug.
Primary outcome: Safety / Tolerability (Assessed by Adverse Events); Phase 1b - PK Assessment: AUC0-last of KPG-818 & KPG-818H; Phase 1b - PK Assessment: AUC0-∞ of KPG-818 & KPG-818H; Phase 1b - PK Assessment: AUCτ of KPG-818 & KPG-818H; Phase 1b - PK Assessment: Css_max of KPG-818 & KPG-818H; Phase 1b - PK Assessment: Css_min of KPG-818 & KPG-818H; Phase 1b - PK Assessment: Tmax of KPG-818 & KPG-818H; Phase 1b - PK Assessment: t1/2 of KPG-818 & KPG-818H; Phase 1b - PK Assessment: CL/F,ss of KPG-818 & KPG-818H; Phase 1b - PK Assessment: Vz/F,ss of KPG-818 & KPG-818H; Phase 2a - PK Assessment: AUC0-last of KPG-818 & KPG-818H; Phase 2a - PK Assessment: AUC0-∞ of KPG-818 & KPG-818H; Phase 2a - PK Assessment: AUCτ of KPG-818 & KPG-818H; Phase 2a - PK Assessment: Css_max…
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 64 participants or records.
Read the paper
Related studies
- eggNOG 5.0: a hierarchical, functionally and phylogenetically annotated orthology resource based on 5090 organisms and 2502 viruses
- Online Survival Analysis Software to Assess the Prognostic Value of Biomarkers Using Transcriptomic Data in Non-Small-Cell Lung Cancer
- OptiType: precision HLA typing from next-generation sequencing data
- Nicotinic Cholinergic System and COVID-19: In Silico Identification of an Interaction between SARS-CoV-2 and Nicotinic Receptors with Potential Therapeutic Targeting Implications
- Saccharomyces cerevisiae cells have three Omega class glutathione S-transferases acting as 1-Cys thiol transferases
- Hemolysis at low blood flow rates: in-vitro and in-silico evaluation of a centrifugal blood pump
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.