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A Study to Understand How a New, Unlicensed Drug (AIC468) Works, Compared With a Placebo, Against BK Virus in Patients Who Have Had a Kidney Transplant.

NCT07503561 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-05-08

No results posted yet for this study

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.

Conditions

  • BK Virus Infection

Interventions

DRUG

AIC263029

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).

DRUG

Placebo

Matching placebo administered by subcutaneous injection

Sponsors & Collaborators

  • AiCuris Anti-infective Cures AG

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-15
Primary Completion
2026-09-30
Completion
2026-12-31
FDA Drug
Yes

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07503561 on ClinicalTrials.gov