AiCuris Anti-infective Cures AG
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.
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). S…
Inclusion Criteria: 1. Male or female aged 18 years or older 2. Kidney transplantation within 12 months prior to randomization 3. First episode of detectable BKV DNA in plasma since last kidney transplantation. As defined by either: 1. positive BKV DNA test of one time \>104 IU/mL and \<106 IU/mL, within 30 days prior to randomization, or 2. \>103 IU/mL and ≤104 IU/mL sustained for at least 2 weeks (confirmed by at least 2 consecutive measurements), with the most recent measurement within 14 days prior to randomization. 4. Female participants (if of childbearing potential) must agree t…
AIC263029 supplied in vials for injection (110 mg/mL) and administered by subcutaneous injection; Part A uses weekly dosing over 4 weeks in planned dose cohorts (100 mg, 200 mg, 330 mg).
Matching placebo administered by subcutaneous injection