Grayslake

Researchers are evaluating how repeated doses of the drug itraconazole affect the way a single dose of ABBV-722 is processed in the body. This Phase 1 study is conducted in healthy adult volunteers to better understand the interaction between these two drugs and their safety and tolerability. The study focuses on detailed measurements of ABBV-722 in the blood after administration with and without itraconazole. The study consists of two periods. In Period 1, participants receive a single dose of ABBV-722 alone. In Period 2, participants take multiple daily doses of itraconazole along with a single dose of ABBV-722. Both drugs are given orally as tablets or capsules. This design allows comparison of ABBV-722 levels in the body with and without itraconazole to observe any changes in drug processing. Participants will have blood samples collected up to day 8 in Period 1 and up to day 14 in Period 2 to measure ABBV-722 concentrations, including peak levels, timing, and overall exposure. Researchers will also monitor for any adverse events up to approximately 45 days. Assessments include medical history, physical exams, vital signs, lab tests, and ECGs to ensure safety throughout the study. The total participation time covers both study periods and follow-up evaluations.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and immune response of ABBV-243, a drug given by intravenous IV or subcutaneous SC injection, in healthy adult volunteers. This Phase 1 trial includes two parts Part 1 tests single ascending doses of ABBV-243 or placebo in healthy adults, and Part 2 evaluates a single IV dose in healthy Asian adults. The study aims to understand how ABBV-243 behaves in the body and its safety profile. Participants will receive either a single IV or SC dose of ABBV-243 or a matching placebo on Day 1. Different groups will get varying doses to assess the effects and how the drug is processed. Specific groups include Han Chinese and Japanese adults who will receive a single IV dose or placebo. The study uses a randomized, double-blind design to compare ABBV-243 against placebo. During the study, participants will attend multiple visits at a hospital or clinic for medical assessments, blood tests, and questionnaires to monitor side effects and drug levels. The main outcomes measured include the number of adverse events, maximum drug concentration in blood, time to reach this concentration, overall drug exposure over time, drug elimination rate, half-life, and the presence of antibodies against ABBV-243. Participants will be followed for safety and drug effects up to Day 204 after dosing.

Researchers are evaluating ABBV-295, a drug administered by subcutaneous injections, in adults with obesity to assess its safety, effects on body weight, and how the body processes the drug. This Phase 1b study focuses on monitoring adverse events and pharmacokinetics in participants with a body mass index between 30.0 and 45.0 kgm2, including those with stable weight-related health conditions. The study is sponsored by AbbVie and aims to better understand ABBV-295s impact in this population. Participants will be randomly assigned to receive either ABBV-295 or a matching placebo through subcutaneous injections for a treatment period lasting 13 to 20 weeks, depending on their assigned group. Several groups are involved, with some receiving 13 weeks of treatment and others up to 20 weeks. The study is triple-blinded, meaning neither participants nor researchers know who receives the drug or placebo during the trial. Throughout the study, participants will be regularly monitored for adverse events, vital signs, electrocardiogram changes, and clinical laboratory test results for up to approximately 194 days. Researchers will also measure various pharmacokinetic parameters of ABBV-295, including plasma concentration levels and antibody development. Body weight changes from baseline will be tracked as a key outcome. The trial includes ongoing safety assessments and a follow-up period to observe lasting effects.

This research aims to evaluate the safety, tolerability, pharmacokinetics, and immune response to single and multiple doses of ABBV-313 in healthy adults aged 18 to 55. The study is a Phase 1 trial sponsored by AbbVie, focusing on how the body reacts to this investigational drug compared to a placebo. Participants will be randomly assigned to receive either ABBV-313 or a placebo through injections or infusions. Some will get a single dose while others will receive multiple doses. The study uses a parallel design with eight groups to assess these different dosing regimens. Throughout the study, participants will be monitored for adverse events and will have blood samples taken to measure drug levels and how the body processes ABBV-313. These evaluations will occur up to approximately 329 days after dosing. The trial involves detailed safety and pharmacokinetic assessments over this period to better understand the drugs effects in healthy volunteers.

Researchers are evaluating the safety, tolerability, and how oral doses of ABBV-1042 move through the body in healthy adult participants. This Phase 1 study aims to understand potential adverse events and how the drug is processed in the body after administration. It is a first-in-human trial sponsored by AbbVie to gather initial safety and pharmacokinetic data in adults aged 18 to 55 years in good health. Participants are randomly assigned to receive a single oral dose of either ABBV-1042 or a placebo on Day 1. The study uses a double-blind design where neither the participants nor the researchers know who receives the drug or placebo. There are multiple groups receiving ascending doses to evaluate different safety and pharmacokinetic profiles. The intervention is an oral solution taken once during the study. During the study, participants will be monitored closely for up to about 32 days to track any adverse events and changes in vital signs, physical exams, electrocardiograms ECG, laboratory tests, and mental health status using the Columbia-Suicide Severity Rating Scale C-SSRS. Blood samples will be collected to measure drug concentrations and how the body metabolizes ABBV-1042. The monitoring period for most assessments is about 3 days post-dose, with extended safety follow-up. Total participation time is approximately one month.

Researchers are evaluating how the drug emraclidine, taken orally, moves through the bodies of healthy elderly adults aged 65 to 85. This Phase 1 study aims to assess the safety, tolerability, and any adverse events related to emraclidine. Participants are healthy volunteers without significant medical conditions, providing important information about how the drug behaves in older adults. Participants will receive oral doses of either emraclidine or a placebo for periods of 10 or 17 days. The study uses a randomized, placebo-controlled design with multiple ascending oral doses to compare how the drug and placebo affect the body. The treatment groups receive the study medication or placebo under close monitoring during these dosing periods. During the study, participants will undergo various assessments including medical history reviews, physical exams, vital signs, electrocardiograms ECGs, and lab tests. Researchers will track adverse events and changes in clinical measures such as movement scales and suicide risk rating scales up to approximately 20 to 50 days. Blood samples will be collected to measure drug levels and how the body processes emraclidine. Overall participation involves careful safety monitoring and evaluation of how the drug is tolerated in healthy elderly adults.

Researchers are evaluating ABBV-859 in healthy adult volunteers to study its safety, tolerability, how it moves through the body pharmacokinetics, and immune response after single increasing doses. This is a Phase 1 clinical trial aimed at understanding these factors in adults aged 18 to 65 who are generally healthy. Participants receive a single dose of ABBV-859 or a matching placebo by oral tablet or intravenous infusion on Study Day 1. The doses increase sequentially across different groups to assess the effects of different dose levels. This study uses a randomized and double-blind design, meaning neither participants nor researchers know who receives the drug or placebo. During the study, participants will be monitored up to 99 days for side effects, drug levels in the blood, and immune reactions. Assessments include physical exams, vital signs, blood tests, ECGs, and tracking of any adverse events. The study also collects measurements like maximum drug concentration, clearance, and antibody development to understand the drugs behavior and safety profile over time.

Researchers are evaluating whether adding immunotherapy drugs brentuximab vedotin and nivolumab to the standard treatment of chemotherapy with or without radiation improves survival for patients aged 5 to 60 with early stage classical Hodgkin lymphoma. This phase III trial compares progression-free survival and overall survival between the standard therapy and the immunotherapy-enhanced approach, as well as patient-reported outcomes and long-term side effects. Participants initially receive two cycles of ABVD chemotherapy every 28 days and then undergo imaging to classify their early response. Based on risk level and response, patients are assigned to one of eight treatment arms that include either continuing standard chemotherapy, receiving immunotherapy drugs, or combinations with involved-site radiation therapy. Treatments are delivered intravenously or orally in cycles lasting 28 days. Imaging and blood samples are collected throughout the trial. Participants are monitored regularly with PET scans, CT or MRI imaging, and blood tests. Follow-up visits occur every 3 months in the first year, then every 6 months for years two and three, and annually up to 12 years from registration. Researchers assess survival outcomes, adverse events, patient-reported symptoms and quality of life, and metabolic tumor burden. Long-term effects such as cardiovascular and pulmonary health are also evaluated using questionnaires and clinical assessments.

Researchers are studying two surgical procedures to reduce the risk of ovarian cancer in women with BRCA1 genetic mutations. This trial compares bilateral salpingectomy, which removes only the fallopian tubes, with bilateral salpingo-oophorectomy, which removes both fallopian tubes and ovaries. The goal is to find out if removing just the fallopian tubes with delayed ovary removal is nearly as effective as removing both from the start. Participants choose between two groups one undergoes bilateral salpingectomy with the option of later ovary removal, and the other undergoes bilateral salpingo-oophorectomy. Both groups have imaging tests like pelvic ultrasounds or pelvic MRIs during screening and provide blood samples throughout the study. Follow-up visits occur at multiple time points, including 10 to 60 days, 6 months, 12 months, 24 months, and then yearly for up to 20 years. During the study, researchers track if ovarian or related cancers develop and assess symptoms related to estrogen loss, quality of life, cancer-related distress, sexual function, menopausal symptoms, medical decision making, and any adverse events. Various questionnaires and imaging tests support these evaluations. Long-term safety and cancer risk reduction are monitored for up to two decades after surgery.

Researchers are evaluating how multiple doses of Itraconazole affect the performance of Nacresertib in healthy adult volunteers aged 18 to 65. The purpose is to assess the safety and drug interaction between these two medications. This Phase 1 study is designed to understand how Itraconazole impacts the behavior of Nacresertib in the body. Participants will receive a single dose of Nacresertib on Day 1 in the first period. In the second period, they will take multiple doses of Itraconazole starting on Day 1, followed by daily single doses from Days 2 through 11, along with a single oral dose of Nacresertib on Day 4. The study uses a crossover design to compare the effects of Nacresertib alone and in combination with Itraconazole. Throughout the study, participants will attend regular weekly and monthly visits at a hospital or clinic. Researchers will conduct medical assessments, blood tests, monitor side effects, and collect questionnaire responses to check the treatment effects. Key measurements include various plasma concentration levels and elimination rates of Nacresertib up to Day 12, ensuring close safety monitoring and detailed drug interaction evaluation.