A Study to Understand How a New, Unlicensed Drug Works, Compared With a Placebo, Against BK Virus in Patients Who Have Had a Kidney Transplant.
brief summary
The goal of this clinical trial is to learn if AIC263029 is safe and well tolerated in adult kidney transplant recipients with BK virus (BKV) in the blood (viremia). The study will also examine how the body processes AIC263029 and whether it lowers BKV levels in the blood. Researchers will compare AIC263029 to a placebo (a look-alike injection with no active drug). Participants will be assigned by chance to receive AIC263029 or placebo and will receive weekly injections under the skin for 4 weeks. Participants will have clinic visits and blood tests during treatment and follow-up to monitor safety and measure BKV levels, and will be followed for up to about 24 weeks after treatment.
detailed description
This study is Part A (Phase 2a) of a randomized, double-blind, placebo-controlled clinical trial evaluating AIC263029 in adult kidney transplant recipients with BK virus (BKV) viremia. Part A is designed to assess safety and tolerability of multiple dose levels, characterize pharmacokinetics (PK), and explore antiviral activity based on changes in plasma BKV DNA.
In Part A, participants are enrolled into sequential dose cohorts. Within each cohort, participants are randomized in a 3:1 ratio to receive AIC263029 or matching placebo. Three dose levels are planned (100 mg, 200 mg, and 330 mg). Study drug is administered as subcutaneous injections once weekly, for a total of five injections over a 4-week treatment period. Up to three additional optional cohorts may be added based on emerging safety, PK, and antiviral activity data.
Participants undergo screening (up to approximately 30 days), followed by the 4-week treatment period and a follow-up period of up to approximately 24 weeks after the end of treatment. Safety evaluations include monitoring of treatment-emergent adverse events, adverse events of special interest (including injection site reactions and kidney transplant outcomes such as graft loss and acute/chronic rejection), and clinically significant changes in laboratory parameters, vital signs, and electrocardiograms. PK sampling is performed to estimate standard PK parameters. Antiviral activity is assessed by quantitative plasma BKV DNA measurements over time, including assessment of change from baseline and time to clinically meaningful reductions. Viral genotyping/resistance monitoring may be performed to assess baseline polymorphisms and potential treatment-emergent resistance.
official title
A Randomized, Adaptive, Double-Blind, Placebo-Controlled, Operationally Seamless Phase 2/3 Clinical Trial to Evaluate the Efficacy, Safety, and Tolerability of AIC263029 in the Treatment of BKV Infection in Kidney Transplant Recipients