ABBV-722 Safety Study in Healthy Adults

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: AbbVie

Disqualifiers: Recent illness, Alcohol, Tobacco, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 14 days

88 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a Phase 1, first-in-human study to investigate safety, tolerability, and pharmacokinetics of ABBV-722 after oral dosing in healthy adult participants.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since this is a study for healthy adults, it's possible that you may need to pause certain medications. Please consult with the study coordinators for specific guidance.

How is the drug ABBV-722 different from other treatments for hepatitis B?

The drug ABBV-722 is unique because it is being studied for safety in healthy adults, but there is no direct information available about its specific differences from other hepatitis B treatments in the provided research. ^{1 2 3 4 5}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

This trial is for healthy adults who want to participate in a study testing a new drug. Specific criteria for joining or being excluded aren't provided, but typically participants must meet certain health standards and not be taking conflicting medications.

Inclusion Criteria

Second-generation participants born outside of Japan must have two parents and four grandparents born in Japan and are of full Japanese descent

Participant must be first- or second-generation Japanese of full Japanese parentage (both parents of Japanese descent), residing outside of Japan. Participants must be in general good health and maintain a typical Japanese lifestyle, including consuming a typical Japanese diet

Participant must be first- or second-generation Han Chinese of full Chinese parentage (both parents of Han Chinese descent), residing outside of China. Participants must be in general good health and maintain a typical Chinese lifestyle, including consuming a typical Chinese diet

Exclusion Criteria

I haven't had any major illness, infection, or surgery in the last 30 days.

I have not consumed alcohol, grapefruit, Seville oranges, starfruit, or tonic water in the last 72 hours.

Use of tobacco or nicotine-containing products within 180 days prior to the first dose of study drug

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive single or multiple ascending doses of ABBV-722 or placebo

14 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ABBV-722

Trial Overview The study is looking at how the body processes ABBV-722 when taken orally, what side effects occur, and if it's easy to tolerate. Some people will get the actual drug while others will receive a placebo (a pill without any active drug) to compare results.

How Is the Trial Designed?

Group I: Part 3: Group 9 Experimental Treatment 2 Interventions

Participants will receive either ABBV-722 Dose C or placebo for 14 days.

Group II: Part 3: Group 8 Experimental Treatment 2 Interventions

Participants will receive either ABBV-722 Dose B or placebo for 14 days.

Group III: Part 3: Group 11 Experimental Treatment 2 Interventions

Participants will receive either ABBV-722 Dose E or placebo for 14 days.

Group IV: Part 3: Group 10 Experimental Treatment 2 Interventions

Participants will receive either ABBV-722 Dose D or placebo for 14 days.

Group V: Part 2: Group 7 Experimental Treatment 1 Intervention

Participants who are Japanese will receive a single dose of ABBV-722 Dose C.

Group VI: Part 2: Group 6 Experimental Treatment 1 Intervention

Participants who are Han Chinese will receive a single dose of ABBV-722 Dose C.

Group VII: Part 1: Group 5 Experimental Treatment 2 Interventions

Participants will receive a single dose of either ABBV-722 Dose E or placebo.

Group VIII: Part 1: Group 4 Experimental Treatment 2 Interventions

Participants will receive a single dose of either ABBV-722 Dose D or placebo.

Group IX: Part 1: Group 3 Experimental Treatment 2 Interventions

Participants will receive a single dose of either ABBV-722 Dose C or placebo.

Group X: Part 1: Group 2 Experimental Treatment 2 Interventions

Participants will receive a single dose of either ABBV-722 Dose B or placebo.

Group XI: Part 1: Group 1 Experimental Treatment 2 Interventions

Participants will receive a single dose of either ABBV-722 Dose A or placebo.

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Published Research Related to This Trial

The novel HBV/MF59 vaccine demonstrated significantly higher immunogenicity compared to the licensed Recombivax HB vaccine, with 89% of recipients achieving protective antibody levels after just one dose, compared to only 12% for the licensed vaccine.

After two doses, the HBV/MF59 vaccine produced a geometric mean titer of 13,422 mIU/ml, over five times higher than the 2,346 mIU/ml from three doses of the licensed vaccine, indicating a much stronger immune response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, controlled study in adults of the immunogenicity of a novel hepatitis B vaccine containing MF59 adjuvant. Heineman, TC., Clements-Mann, ML., Poland, GA., et al.[2019]

The experimental hepatitis B vaccine (HB-AS04) demonstrated nearly 100% seroprotection rates and produced two-fold higher antibody levels compared to a licensed vaccine in a study involving 1303 healthy volunteers.

Both the HB-AS04 and the licensed vaccine were well tolerated, indicating that the safety profile of the new vaccine is comparable to that of the established vaccine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity profile of an experimental hepatitis B vaccine adjuvanted with AS04. Boland, G., Beran, J., Lievens, M., et al.[2006]

In a study of 399 healthy adult workers, both vaccination schedules (0-1-12 months and 0-1-6 months) provided similar high rates of seroconversion and seroprotection against hepatitis B virus, indicating both schedules are effective.

The 0-1-12 month schedule resulted in significantly higher geometric mean concentrations of anti-HBs compared to the 0-1-6 month schedule, suggesting that while both are effective, the longer schedule may enhance antibody levels, albeit with a delayed onset of protection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative immunogenicity of two vaccination schedules of a combined hepatitis A and B vaccine in healthy volunteers. De Schryver, A., Verstrepen, K., Vandersmissen, L., et al.[2013]

In a study involving 509 participants, including 343 healthy adults and 166 hemodialysis patients, the experimental German Hepatitis B Vaccine showed low-intensity and short-duration local and systemic adverse reactions, particularly after the first dose.

The vaccine was found to be non-infectious, meaning it did not cause hepatitis B infections or other viral or bacterial infections, and it did not induce any harmful immune responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Active hepatitis B immunization with an experimental German vaccine. IV. Reactogenicity studies in healthy adults and in hemodialysis patients. Scheiermann, N., Kuwert, EK.[2009]

In a Phase III study involving 450 healthy adults, the investigational HB-AS02 vaccine demonstrated high seroprotection rates, with 75.9% of participants achieving protective antibody levels after the first dose and 100% after the second dose.

The vaccine was well-tolerated, with mild to moderate local and general symptoms reported after 80.7% and 45.5% of doses, respectively, and no participants withdrew due to adverse events, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of an investigational adjuvanted hepatitis B vaccine (HB-AS02V) in healthy adults. Beran, J., Hobzova, L., Wertzova, V., et al.[2021]

Citations

1. Netherlands pubmed.ncbi.nlm.nih.gov

A randomized, controlled study in adults of the immunogenicity of a novel hepatitis B vaccine containing MF59 adjuvant. [2019]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity profile of an experimental hepatitis B vaccine adjuvanted with AS04. [2006]

3. England pubmed.ncbi.nlm.nih.gov

Comparative immunogenicity of two vaccination schedules of a combined hepatitis A and B vaccine in healthy volunteers. [2013]

4. Germany pubmed.ncbi.nlm.nih.gov

Active hepatitis B immunization with an experimental German vaccine. IV. Reactogenicity studies in healthy adults and in hemodialysis patients. [2009]

5. United States pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of an investigational adjuvanted hepatitis B vaccine (HB-AS02V) in healthy adults. [2021]