Chatsworth

Researchers are evaluating new medicines to prevent Human Immunodeficiency Virus Type 1 (HIV-1) infection, focusing on women assigned female at birth who are cisgender. This Phase 3 clinical trial aims to determine whether taking the drug MK-8527 once a month is more effective than the usual daily pre-exposure prophylaxis (PrEP) medication in preventing HIV-1 infection. The study also seeks to understand the safety and tolerability of MK-8527 in this population. Participants will be randomly assigned to receive one of several oral tablets: MK-8527 once monthly, a standard daily PrEP medication called Emtricitabine/tenofovir disoproxil (FTC/TDF), or placebo tablets matched to each drug. This double-blind study compares these groups to assess both the effectiveness and side effects of MK-8527 over time. During the study, participants will be monitored for up to about two years to track new HIV-1 infections, any adverse events they experience, and whether they stop taking the study medication due to side effects. Researchers will regularly evaluate participants' health, safety, and adherence to the treatment plan throughout this period.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and neutralization of three broadly neutralizing monoclonal antibodies—VRC07-523LS, PGT121.414.LS, and PGDM1400LS—administered intravenously in adults without HIV. This is a randomized, double-blind, controlled phase 2 clinical trial involving approximately 200 adult participants aged 18 to 65 years. The study aims to understand how these antibody combinations behave in the body and their safety profile over an 18-month participation period. Participants will receive intravenous infusions of the antibodies at different dosages: VRC07-523LS at 400 mg or 3200 mg, PGT121.414.LS at 400 mg or 1600 mg, and PGDM1400LS at 400 mg or 1600 mg. The study includes controlled administration of these biological treatments to assess their effects at varying dose levels. During the study, participants will undergo multiple assessments including monitoring for local and systemic adverse events at specific days (1, 4, 7, 169, and 173), and monitoring for unsolicited and serious adverse events throughout 48 weeks. Laboratory tests will evaluate changes in liver enzymes (ALT, AST, alkaline phosphatase), kidney function (creatinine), and complete blood count at baseline and several points up to day 337. Researchers will also track any early discontinuations and overall tolerability throughout the study duration.

Hidradenitis suppurativa (HS) is a chronic and often painful skin disease that causes lumps, abscesses, and scars in areas like under the breasts, armpits, inner thighs, groin, and buttocks. Researchers are evaluating the investigational drug lutikizumab compared to placebo in adults and adolescents with moderate to severe HS. This study aims to assess the disease activity and safety of lutikizumab in a Phase 3 clinical trial involving about 1280 participants worldwide.

The purpose of the study is to evaluate whether ibuzatrelvir is effective and safe in adults and adolescents with COVID-19 who do not need to be in the hospital but who are at high risk for progression to severe disease. Eligible participants will be randomly assigned (by chance) to receive ibuzatrelvir or matching placebo orally for 5 days. Co-administration of locally available standard of care is allowed. The total duration of the study is around 6 months.