Publications by authors named "P Van Remoortere"
Article Synopsis
- Chronic hepatitis B (CHB) poses a significant health challenge globally, and while there are limited treatment options, the oral drug JNJ-64794964 (JNJ-4964) is being tested for its potential effectiveness as a TLR7 agonist.
- In a phase 1 trial involving healthy volunteers, researchers analyzed blood samples to observe changes in gene expression and immune cell activity after administering JNJ-4964, finding notable increases in interferon-stimulated genes and activated natural killer (NK) and B cells.
- The results indicate that JNJ-4964 not only triggers a range of immune responses but also provides insights that could help develop biomarkers for monitoring CHB patients treated with TLR7 agonists
Background: JNJ-4964 is a TLR7 agonist, which, via a type I interferon (IFN)-dependent mechanism, may enhance host immunity suppressed by persistent exposure to hepatitis B antigens in chronic hepatitis B.
Methods: PK and PD data were pooled from 2 studies involving 90 participants ( = 74 JNJ-4964, dose range 0.2-1.
Background: This Phase I, two-part, first-in-human study assessed safety/tolerability and pharmacokinetics/pharmacodynamics of single-ascending doses (SAD) and multiple doses (MD) of the oral toll-like receptor-7 agonist, JNJ-64794964 (JNJ-4964) in healthy adults.
Methods: In the SAD phase, participants received JNJ-4964 0.2 ( = 6), 0.
Objectives: We investigated JNJ-64530440 (a hepatitis B virus capsid assembly modulator) safety, antiviral activity and pharmacokinetics in patients with chronic hepatitis B (CHB) (Phase 1b, NCT03439488).
Methods: Twenty treatment-naive, HBeAg-positive or -negative CHB patients were randomized 4:1 to JNJ-64530440 750 mg once or twice daily, or placebo for 28 days.
Results: All patients (mean age 43.
Pharmacokinetics, safety and tolerability of single- and multiple-ascending doses of JNJ-64530440, a novel hepatitis B virus capsid assembly modulator, in healthy volunteers.
Antivir Ther
May 2022
Background: Pharmacokinetics and safety of JNJ-64530440, a hepatitis B virus capsid assembly modulator producing normal empty capsids (CAM-N), in healthy volunteers were evaluated.
Methods: This Phase I study (NCT03439488) was a double-blind, randomised, placebo-controlled study. Adults ( = 10/cohort, five Asian/five non-Asian), randomised 4:1, received single-ascending doses of oral JNJ-64530440 (first- and second-generation formulations) or placebo under fasted (50, 150, 300 and 900 mg) or fed (300, 750, 1,000, 2000 and 4000 mg) conditions.