ABBV-722 Safety Study in Healthy Adults
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: AbbVie
Disqualifiers: Recent illness, Alcohol, Tobacco, others
No Placebo Group
Trial Summary
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.
Eligibility Criteria
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
+6 more
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
Trial Timeline
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
Participant Groups
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.
11Treatment groups
Experimental Treatment
Group I: Part 3: Group 9Experimental Treatment2 Interventions
Participants will receive either ABBV-722 Dose C or placebo for 14 days.
Group II: Part 3: Group 8Experimental Treatment2 Interventions
Participants will receive either ABBV-722 Dose B or placebo for 14 days.
Group III: Part 3: Group 11Experimental Treatment2 Interventions
Participants will receive either ABBV-722 Dose E or placebo for 14 days.
Group IV: Part 3: Group 10Experimental Treatment2 Interventions
Participants will receive either ABBV-722 Dose D or placebo for 14 days.
Group V: Part 2: Group 7Experimental Treatment1 Intervention
Participants who are Japanese will receive a single dose of ABBV-722 Dose C.
Group VI: Part 2: Group 6Experimental Treatment1 Intervention
Participants who are Han Chinese will receive a single dose of ABBV-722 Dose C.
Group VII: Part 1: Group 5Experimental Treatment2 Interventions
Participants will receive a single dose of either ABBV-722 Dose E or placebo.
Group VIII: Part 1: Group 4Experimental Treatment2 Interventions
Participants will receive a single dose of either ABBV-722 Dose D or placebo.
Group IX: Part 1: Group 3Experimental Treatment2 Interventions
Participants will receive a single dose of either ABBV-722 Dose C or placebo.
Group X: Part 1: Group 2Experimental Treatment2 Interventions
Participants will receive a single dose of either ABBV-722 Dose B or placebo.
Group XI: Part 1: Group 1Experimental Treatment2 Interventions
Participants will receive a single dose of either ABBV-722 Dose A or placebo.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Acpru /Id# 270279Grayslake, IL
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Who Is Running the Clinical Trial?
AbbVieLead Sponsor
References
A randomized, controlled study in adults of the immunogenicity of a novel hepatitis B vaccine containing MF59 adjuvant. [2019]The safety and immunogenicity of a novel hepatitis B virus (HBV) vaccine containing recombinant PreS2 and S antigens combined with MF59 adjuvant (HBV/MF59) was evaluated in healthy adults (N=230) who were randomized to receive 2 or 3 immunizations of either the study vaccine or a licensed control vaccine (Recombivax HB). After a single immunization, 105 of 118 (89%) recipients of HBV/MF59 achieved protective serum levels of anti-HBs antibody (> 10 mIU/ml), compared with 13 of 110 (12%) recipients of licensed vaccine (P
Safety and immunogenicity profile of an experimental hepatitis B vaccine adjuvanted with AS04. [2006]The reactogenicity and safety of an experimental hepatitis B (HB) vaccine containing adjuvant system (AS04) was compared with a licensed vaccine in a phase III, single-blind, randomised study in healthy volunteers >or=15 years of age. A total of 1303 subjects were enrolled to receive either two doses of HB-AS04 (0, 6 months) or three doses of the comparator vaccine (0, 1, 6 months). Two doses of HB-AS04 elicited seroprotection rates close to 100% and two-fold higher GMTs than the comparator vaccine. Results showed that both vaccines were well tolerated and the general safety profile of HB-AS04 was similar to that of the comparator vaccine.
Comparative immunogenicity of two vaccination schedules of a combined hepatitis A and B vaccine in healthy volunteers. [2013]In 1996, a combined vaccine against both hepatitis A and B was licensed and commercialized and has been recommended for healthcare personnel in Belgium. This study compares the immunogenicity against hepatitis B virus (HBV) and safety of two vaccination schedules (0-1-12 months and 0-1-6 months) with this vaccine. This is a randomized, stratified and controlled study in healthy adult workers, who are not occupationally exposed to HBV. Seroconversion (≥1 IU/L) and seroprotection (≥10 IU/L) rates were compared using Fisher's exact test; geometric mean concentrations (GMCs) of anti-HBs were compared using one-way ANOVA. All statistical analyses were carried out with SPSS 11 on Apple Macintosh. A total of 399 subjects were enrolled in the study, and 356 were analysed according to the protocol. The rate of ≥10 IU/L at 6 months was 70.6% in the group 0-1-12 and 79.9% in the group 0-1-6; this rate decreased to 55.9% at 12 months in the first group. Seroconversion and seroprotective rates against HBV measured at month 13 in group 0-1-12 (98.9% and 95.6%) and measured at month 7 in group 0-1-6 (99.4% and 97.1%) were not statistically significantly different. GMC of anti-HBs after the 0-1-12 schedule was more than two fold higher than after 0-1-6 schedule (P
Active hepatitis B immunization with an experimental German vaccine. IV. Reactogenicity studies in healthy adults and in hemodialysis patients. [2009]Reactogenicity testing was performed accompanying vaccination with the experimental German Hepatitis B Vaccine. 509 individuals, among them 343 healthy adults and 166 hemodialysis patients, were vaccinated with three doses of vaccine. The evaluation of questionnaires indicated that local and systemic adverse reactions were of low intensity and short duration. The rates of reactions were highest following the first and lowest after the third vaccination. The vaccine did not induce immunopathological alterations. The vaccine was non-infectious and thus not the cause of hepatitis B infections nor of other viral or bacterial infections.
Safety and immunogenicity of an investigational adjuvanted hepatitis B vaccine (HB-AS02V) in healthy adults. [2021]HB-AS02 is an investigational adjuvanted hepatitis B virus (HBV) vaccine for potential use in patients with renal insufficiency and other immunocompromized individuals. In this Phase III lot-to-lot consistency study, 450 healthy adult volunteers who had not previously been vaccinated against HBV were randomized to one of three production lots of HB-AS02 at 0 and 1 month and followed until one month after the last vaccine dose. Lot-to-lot consistency was established. High seroprotection rates were already achieved after the first vaccine dose (75.9%). All subjects were seroprotected (anti-HBs antibody concentrations ≥10 mIU/ml) after two doses, with all but one subject achieving anti-HBs antibody concentrations ≥100 mIU/ml (99.7%). Geometric mean anti-HBs antibody concentration was 4594.5 mIU/ml. Local and general symptoms were reported after 80.7% and 45.5% of doses, respectively. However, these were mainly of mild or moderate severity and no subject withdrew from the study due to adverse events.