RecruitingPhase 1ACTRN12624000808549

A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Cavrotolimod in Subjects with Chronic Hepatitis B Infection

A Phase 1b/2 Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Cavrotolimod Alone and in Combinations in Subjects with Chronic Hepatitis B Infection- Part A

Sponsor

Bluejay Therapeutics, Inc

Enrollment

40 participants

Start Date

Aug 5, 2024

Study Type

Interventional

Conditions

Chronic Hepatitis B Infection

Summary

This is a Phase 1b study to evaluate the safety and tolerability, PK/PD, and antiviral activity/efficacy of cavrotolimod and cavrotolimod-containing combinations in CHB infected subjects who are on nucleos(t)ide therapy. Cavrotolimod ± BJT-778 is being developed to address the high unmet medical need with possible benefits for participants with Chronic Hepatis B virus infection (CHB). This study will enroll non-cirrhotic, chronic hepatitis B (CHB) infected adults aged 18-65 years of age, inclusive, on nucleos(t)ide therapy. The study consists of two parts (Part A and Part B). Part A is multiple ascending dose study with 5 cohorts. Each cohort will enroll a total of 4 participants with 3 randomized to treatment arm and 1 randomized to the placebo treatment arm. Safety Review Committee will review the participant safety data as needed and determine dose escalation to the next cohort.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Plain Language Summary

Simplified for easier understanding

Chronic hepatitis B (CHB) is a viral infection that affects the liver and, if untreated, can lead to cirrhosis and liver cancer. While existing antiviral medications (called nucleos(t)ide analogues) keep the virus under control, they rarely clear the infection entirely. A cure remains elusive, and there is a significant need for new treatments that can bring the virus to undetectable levels. This Phase 1b study is testing a new drug called cavrotolimod, either alone or combined with another agent, in people with CHB who are already taking antiviral therapy. The study is assessing whether cavrotolimod is safe, how it moves through the body, and whether it has any effect on the virus. You may be eligible if you are aged 18 to 65, have had chronic hepatitis B for at least six months, are currently on stable antiviral medication, and have a very low level of the virus in your blood. People with advanced liver disease, cirrhosis, HIV, or hepatitis C would not be eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

Investigational Product (IP): Cavrotolimod and BJT-778 Dosage Form: Vial Method of administration: Sub cutaneous injection Dose: Cavrotolimod will be supplied as 2mL vial and BJT-778 will be supp

Investigational Product (IP): Cavrotolimod and BJT-778 Dosage Form: Vial Method of administration: Sub cutaneous injection Dose: Cavrotolimod will be supplied as 2mL vial and BJT-778 will be supplied as 6 mL glass vial. The study consists of Two parts (Part A and Part B). This registration contains details of Part A. Part A is a randomized, double-blind, placebo-controlled portion of the study to evaluate multiple ascending doses (MAD) of cavrotolimod (20 mg/mL vial) administered subcutaneously (SC) in sequential cohorts. Four (4) subjects per cohort will be enrolled and randomized 3:1, active to placebo, respectively Part A- Cohort 1: Cavrotolimod 2 mg or placebo administered SC every week for 1 month Cohort 2: Cavrotolimod (less than equal to) 6 mg or placebo administered SC for 1 month Cohort 3: Cavrotolimod (less than equal to) 16 mg or placebo administered SC for 1 month Optional Cohort 4: Cavrotolimod (less than equal to) 24 mg or placebo administered SC for 1 month Optional Cohort 5: Cavrotolimod (less than equal to) 24 mg or placebo administered SC for 1 month. Subjects will continue to be followed for 5 weeks after the last dose of cavrotolimod. Dose escalation to next cohort will only proceed only safety review meetings where it is confirmed to proceed to next dosing cohort, Emerging safety and PD data will be reviewed at Safety Review Meetings to confirm the dose and frequency of SC administration (e.g., weekly or extend to every 2 weeks) of cavrotolimod to be evaluated in Cohorts 2-5. Adherence is not monitored as cavrotolimod or placebo will be injected by the site staff. Optional cohorts 4 and 5 may be included to explore additional dose levels and/or dosing regimens. Optional cohorts 4 and 5 may also be included to extend an existing dose level and/or dosing regimens for the purposes of gathering further information at that dose level.