JNJ-64530440 / J&J - LARVOL DELTA

Pharmacokinetics, safety and tolerability of single- and multiple-ascending doses of JNJ-64530440, a novel hepatitis B virus capsid assembly modulator, in healthy volunteers. (PubMed, Antivir Ther) - P1 | "Single (up to 4000 mg) and multiple doses (up to 2000 mg for 7 days) of JNJ-64530440 were well tolerated in healthy volunteers. Multiple doses ≥750 mg/day achieved plasma concentrations expected to have antiviral activity that may lower hepatitis B surface antigen. No clinically relevant differences in tolerability or pharmacokinetic parameters were seen between Asians versus Caucasians."

Clinical • Journal • P1 data • PK/PD data • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Safety, antiviral activity and pharmacokinetics of JNJ-64530440, a novel capsid assembly modulator, as 4 week monotherapy in treatment-naive patients with chronic hepatitis B virus infection. (PubMed, J Antimicrob Chemother) - P1 | "JNJ-64530440 750 mg once-daily or twice-daily for 28 days was well tolerated and achieved potent antiviral activity in CHB patients."

Clinical • Journal • Monotherapy • PK/PD data • Fatigue • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Pain

Study in Women on the Effect of JNJ-64530440 on Oral Contraceptive and Midazolam, and the Effect of a High-fat Meal on JNJ-64530440 (clinicaltrials.gov) - P1; N=0; Withdrawn; Sponsor: Janssen Research & Development, LLC; N=16 ➔ 0; Suspended ➔ Withdrawn

Clinical • Enrollment change • Trial withdrawal

Study in Women on the Effect of JNJ-64530440 on Oral Contraceptive and Midazolam, and the Effect of a High-fat Meal on JNJ-64530440 (clinicaltrials.gov) - P1; N=16; Suspended; Sponsor: Janssen Research & Development, LLC; Trial primary completion date: Nov 2021 ➔ Aug 2021

Clinical • Trial primary completion date

Study in Women on the Effect of JNJ-64530440 on Oral Contraceptive and Midazolam, and the Effect of a High-fat Meal on JNJ-64530440 (clinicaltrials.gov) - P1; N=16; Suspended; Sponsor: Janssen Research & Development, LLC; Trial completion date: Apr 2020 ➔ Nov 2021; Trial primary completion date: Apr 2020 ➔ Nov 2021

Clinical • Trial completion date • Trial primary completion date • Long-acting Reversible Contraceptives • Women's Health

Study in Women on the Effect of JNJ-64530440 on Oral Contraceptive and Midazolam, and the Effect of a High-fat Meal on JNJ-64530440 (clinicaltrials.gov) - P1; N=16; Suspended; Sponsor: Janssen Research & Development, LLC; Not yet recruiting ➔ Suspended

Clinical • Trial suspension

A Study of JNJ-64530440 in Healthy Japanese Male Participants (clinicaltrials.gov) - P1; N=16; Terminated; Sponsor: Janssen Pharmaceutical K.K.; N=24 ➔ 16; Trial completion date: Jan 2020 ➔ Jul 2019; Recruiting ➔ Terminated; Trial primary completion date: Oct 2019 ➔ Jul 2019; Stopped due to a strategic decision.

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Trial termination

Study in Women on the Effect of JNJ-64530440 on Oral Contraceptive and Midazolam, and the Effect of a High-fat Meal on JNJ-64530440 (clinicaltrials.gov) - P1; N=16; Not yet recruiting; Sponsor: Janssen Research & Development, LLC; Initiation date: Dec 2019 ➔ Mar 2020

Clinical • Trial initiation date

A Study of Orally Administered JNJ-440 to Evaluate the Safety, Tolerability, and Pharmacokinetics After Single Ascending Doses Including Food Effect Evaluation; After Multi-Day Dosing in Healthy Participants; and After Multiple (Ascending) Doses in Participants With Chronic Hepatitis B (clinicaltrials.gov) - P1; N=130; Completed; Sponsor: Alios Biopharma Inc.; Recruiting ➔ Completed

Clinical • Trial completion

JNJ-64530440 (JNJ-0440), A NOVEL CLASS N CAPSID ASSEMBLY MODULATOR (CAM-N): SAFETY, TOLERABILITY, PHARMACOKINETICS (PK), AND ANTIVIRAL ACTIVITY OF MULTIPLE ASCENDING DOSES IN PATIENTS (PTS) WITH CHRONIC HEPATITIS B (CHB) (AASLD 2019) - P1; "JNJ-0440 750 mg QD or BID administered over 28 days was generally well tolerated and resulted in potent antiviral activity in adults with CHB."

Clinical • PK/PD data

"Our old #hepC friend Ed Gane is now presenting on JNJ-0440 capsid inhibitor for #HepB. #LiverMtg19 #LiverSnaps @JanssenUS" (@LizHIVHep)

A Study of JNJ-64530440 in Healthy Japanese Male Participants (clinicaltrials.gov) - P1; N=24; Recruiting; Sponsor: Janssen Pharmaceutical K.K.; Trial completion date: Jul 2019 ➔ Jan 2020; Trial primary completion date: Jul 2019 ➔ Oct 2019

Clinical • Trial completion date • Trial primary completion date

"#AASLD19 #HBV $JNJ JNJ-64530440 seems to be the new leader in capsid assembly modulator class : potent HBV DNA reduction + Good safety. *Mean hbv dna red. at day 28 (ph1b data)* - 3.3 $JNJ - 2.9 ABI-H0731 $ASMB - 2.8 AB-506 $ABUS - 2.7 RO7049389 $RHHBY" (@CaesarBiotech)

Clinical

Study in Women on the Effect of JNJ-64530440 on Oral Contraceptive and Midazolam, and the Effect of a High-fat Meal on JNJ-64530440 (clinicaltrials.gov) - P1; N=16; Recruiting; Sponsor: Janssen Research & Development, LLC; Trial completion date: Nov 2019 ➔ Apr 2020; Initiation date: Mar 2019 ➔ Dec 2019; Trial primary completion date: Nov 2019 ➔ Apr 2020

Clinical • Trial completion date • Trial initiation date • Trial primary completion date