Clinical Research Directory

A Study to Determine the Safety and Tolerability of AG-236 and How it is Absorbed, Broken Down, and Eliminated From the Body in Healthy Participants

The primary purpose of this study is to assess the safety and tolerability of a single dose of AG-236 administered subcutaneously in healthy participants.

A Study to Investigate Safety, Tolerability, and Pharmacokinetics of AZD3974 in Healthy Participants

The purpose of this study is to assess the safety and tolerability of AZD3974 and characterize the pharmacokinetics (PK) of AZD3974 following oral administration to healthy participants, including participants of Japanese and Chinese descent.

A First-in-Human Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single and Multiple Oral Doses of Debio 1453P in Healthy Adults

The main purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) of Debio 1453P compared to placebo across different dose levels in healthy adults after single and repeated oral dosing.

A Phase I Study of KLA318-2 Nanocrystal Injection

The purpose of this study is to evaluate the safety,tolerability and pharmacokinetics properties of KLA318-2 Nanocrystal Injection after a single intravenous injection in healthy participants.

A Mutiple-dose Study of IBI3033 in Healthy Participants

This is a Phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of IBI3033 in Chinese healthy participants. The entire trial cycle includes a 4-week screening period, 8-week treatment period and 8-week follow-up period.

Drug-drug Interaction Trial of AP31969 and Carbamazepine or Itraconazole

The primary objective of the trial is to assess the effect of multiple doses of the cytochrome P450 (CYP3A4) enzyme inducer carbamazepine (Part A) or the CYP3A4 inhibitor itraconazole (Part B) on the single-dose pharmacokinetics (PK) of AP31969 in healthy participants.

A First-in-human, Single-ascending-dose Study of IBI3033 in Healthy Participants

This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of IBI3033 in Chinese healthy participants. The entire trial cycle includes a 4-week screening period, 1-day treatment period and 12-week follow-up period.

Location- and Frequency-Dependent Effects of Thalamic Temporal Interference Stimulation During Sleep

This study is to find out whether a type of non-invasive electrical brain stimulation called temporal interference transcranial electrical stimulation (TI-TES) can temporarily change brain activity during sleep, especially sleep spindles (brain rhythms in the \~8-16 Hz range). Up to 24 healthy participants in Dane County, Wisconsin will be enrolled for 3 overnight study visits. Participants can expect to be on study for approximately 5 weeks, depending on scheduling availability.

A Study to Investigate the Pharmacokinetics of Different Formulations and Safety of AZD5004 in Healthy Participants Aged 18 to 55 Years

The purpose of this study is to assess the pharmacokinetics (PK), safety and tolerability of different oral formulations of AZD5004, and to evaluate the effect of food on these formulations in healthy participants.

Prospective Study for the Development, Validation and Confirmation of a Multi-Cancer Early Detection Platform Through Whole-Genome Sequencing Analysis of Circulating DNA in Cancer and Non-Cancer Subjects

This is a prospective, multi-center clinical study of Multi-Cancer Early Detection (MCED) testing in cancer patients and healthy volunteers. This study was designed to establish a clinical and molecular database using circulating DNA from both cancer patients and non-cancer participants, advance and validate an artificial intelligence platform capable of detecting various types of cancer at an early stage, and evaluate its performance.

A Study to Assess the Bioequivalence of Trastuzumab Via Different Subcutaneous Delivery Platforms in Healthy Male Participants

This two-part study will evaluate the bioequivalence, safety, and tolerability of a single SC dose of trastuzumab administered via handheld syringe/syringe pump (HHS/SP) with infusion set (IS) and an on-body delivery system (OBDS).

Study of an RSV-hMPV-PIV3 Trivalent Vaccine Candidate VXB-251 in Older Adults

This study is being done to find out how safe and effective a new combined vaccine candidate, called VXB-251, is for older adults. The vaccine candidate is designed to protect against three common viruses that can cause respiratory tract infections: * RSV (respiratory syncytial virus) * hMPV (human metapneumovirus) * PIV3 (parainfluenza virus type 3) Two components of this vaccine (RSV and hMPV) have already been tested in people before, as part of another study for a two-in-one vaccine. However, this is the first time that the PIV3 component and all three components together (RSV, hMPV, and PIV3) are being tested in people. The vaccine candidate will be given as a single intramuscular injection. The study will also test unlicensed comparator vaccines and a placebo (a substance that looks like the real vaccine but doesn't contain any active ingredients) that target none, one or two of these viruses to see whether combining all three components affects safety or how well the immune system responds.

VR for Hope: A Brief VR Self-help Protocol to Enhance Hope and Well-being in Young Adults

The objective of this study is to evaluate the feasibility of a brief self-help protocol based on immersive Virtual Reality (VR) to promote hope and psychological well-being in young adults while enhancing their mentalization capacity. The intervention consists of five sessions. The first session will be conducted in person and features an immersive VR experience, while the subsequent sessions will be delivered in a self-help format via audio and video materials. The intervention is designed to guide participants through personal reflection on key aspects of individual experience, such as hope and the understanding of one's own and others' mental states. Participants will complete self-report questionnaires before (T0) and after (T1) the intervention to assess levels of hope, psychological well-being, and mentalization capacity.

Testing Non-Invasive Spinal Stimulation Devices

The purpose of this study is to compare updated spinal stimulation devices with the spinal stimulation device that is currently used. Spinal stimulation is often used in studies aimed at assisting individuals with a spinal cord injury. These devices were updated to improve upon limitations in the currently used device. The devices will be compared in a group of people without spinal cord injury or other nervous system conditions.

fMRI Evaluation of Auricular Acupuncture Targets: An Exploratory Clinical Study

This study employs resting-state functional magnetic resonance imaging (rs-fMRI) to examine whether auricular press needles acupuncture modulates functional connectivity between the insula and medial prefrontal cortex (MPFC), in a manner comparable to transcranial vagus nerve stimulation (taVNS), and to assess its association with interoceptive improvement. By establishing a neurophysiological baseline for auricular vagus nerve stimulation (aVNS) in the healthy brain, the research aims to clarify its regulatory mechanisms in cognition and emotion. The findings provide a key theoretical and evaluative framework for translating aVNS into clinical applications for insomnia and depression.

Gait Analysis Parameter and Upper Limb Evaluation in Control Participants

The ActiControl study is a monocentric, academic, and fully remote observational study designed to build a normative, longitudinal dataset using the Syde® wearable device. The study will enroll 200 healthy volunteers across all age groups, genders, and backgrounds. Participants will be remotely recruited and followed over two years, wearing the Syde® device for 3-week periods every 6 months. All study visits, including consent, data collection, and follow-up, are conducted remotely via phone or video conferencing. The primary objectives are to collect reference data on gait and movement patterns and to assess adherence and acceptability of the device. Secondary objectives include evaluating the reliability of digital endpoints and the influence of demographic and lifestyle factors on these measures.

Study of TGM-312-SC01 in Healthy Participants and Adults With MASH

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) effects of single ascending doses of TGM-312-SC01 in healthy adults and multiple ascending doses in patients with metabolic dysfunction-associated steatohepatitis (MASH).

Synaptic Mechanisms of Intermittent Theta Burst Stimulation for Major Depressive Disorder

Many people with depression do not get better with standard treatments like medications or talk therapy. Transcranial magnetic stimulation (TMS) is a non-invasive brain stimulation treatment that uses magnetic pulses to stimulate areas of the brain involved in depression. One form of TMS called intermittent theta burst stimulation (iTBS) is FDA-cleared for depression and takes only 3 minutes to deliver. However, about one-third of patients do not respond to iTBS, and another one-third do not reach full remission. Improving iTBS requires a better understanding of how it works in the brain. iTBS is thought to work by strengthening connections between brain cells, a process called synaptic plasticity. This process depends on a type of brain receptor called the NMDA receptor. Most of what researchers know about how iTBS affects these connections comes from studies of healthy people. It is not known whether iTBS works the same way in the prefrontal cortex - the brain region targeted during depression treatment - or in people who actually have depression. This study has two phases. In Phase 1, both healthy volunteers and people with depression will complete 4 research visits to test how iTBS changes brain activity in the prefrontal cortex and whether medications that increase or decrease NMDA receptor activity change those effects. Each visit involves active or sham (inactive) iTBS combined with one of three study medications: a placebo (inactive pill), d-cycloserine (a medication that increases NMDA receptor activity), or dextromethorphan (a medication that decreases NMDA receptor activity). Brain activity is measured before and after each TMS session using electroencephalography (EEG), a painless test that records electrical signals from the scalp through a cap placed on the head. All participants also complete a brain MRI before beginning study visits for targeting purposes. In Phase 2, participants with depression will be offered a standard clinical course of 30 daily iTBS sessions (Monday through Friday over 6 weeks). Each session is combined with one blinded study medication (placebo, d-cycloserine, or dextromethorphan) taken daily. Brain activity measurements and standard depression and anxiety questionnaires are collected weekly throughout this phase to track how the brain changes over the course of treatment and whether those changes relate to improvements in symptoms. Together, the two phases of this study aim to identify the brain mechanism by which iTBS works in people with depression. This knowledge could lead to more effective TMS treatments for people who have not responded to medications or other therapies.

A Study to Assess the Relative Bioavailability of Different Subcutaneous Formulations ofAZD6234

This study in healthy volunteers aims to compare blood levels and side effects after administration of different formulations of AZD6234. This study will take place at one site in Nottingham, United Kingdom, and will enrol 21 healthy men and women aged 18-55 years.

Virtual Reality Assisted Schema Therapy

Schema therapy helps people understand which emotional needs were not met during childhood, and how they can take care of those needs now. One important part of the therapy is the chairwork exercise, where people imagine talking to different parts of themselves (like the strict parent or the hurt child) using empty chairs. These exercises can be very helpful, but they can also be difficult for people who find it hard to imagine things in their mind. Virtual Reality (VR) can make these exercises easier and more powerful. VR creates a 3D world that feels real, using special equipment like a headset. In this world, people can see and interact with virtual characters that represent different parts of themselves. This can make the therapy more concrete and easier to understand, especially for people who struggle with imagination. In this study, the investigators want to compare the regular imagination-based exercise with the chairwork exercise done in Virtual Reality. Everyone who joins the study will do both versions of the exercise-one with imagination and one with VR. The order will be random. Before and after each exercise, a short assessment will be conducted to see how people feel. At the end, there will also be a short interview about their experience. The whole session will take about 1.5 to 2 hours. The investigators want to know if people experience the VR exercise differently than the regular imagination exercise. The investigators also want to know if these differences depend on how well someone can imagine things in their mind.

A Study to Investigate the Effect of AZD5004 on Mitiglinide and Pioglitazone in Healthy Participants

The purpose of the study is to assess the effect of AZD5004 on the pharmacokinetics (PK) of mitiglinide and pioglitazone in healthy participants.

A Phase I/II, Dose-finding Study to Assess the Safety, Reactogenicity, and Immunogenicity of a Broadly Protective Sarbecovirus Vaccine (GBP511) in Healthy Adults.

The purpose of this research study is to evaluate the safety of and the body's immune response to single and multiple vaccinations in healthy men and women. We want to find out what effects GBP511 has on you and your health. We are doing this study to find out: If the study drug has any side effects when given as single and multiple vaccinations. If reactogenicity, an indication that the immune systems is working and is preparing to protect the body against future infection, occurs. This is a normal physical inflammatory response that occurs after vaccination, manifesting as localised reactions that may include pain or redness at the injection site, or systemic symptoms such as headache or fever. If immunogenicity which is when GBP511 causes your body to make antibodies against the non-harmful viral proteins contained within GBP511, called 'neutralising antibodies (Nab),' occurs. And if GBP511 will cause the specialised cells of the body's immune system to mount a defence against the non-harmful viral proteins contained within GBP511, called 'cell-mediated immunity (CMI)'. In this study, GBP511 will be administered with and without adjuvant, CAS-1. An adjuvant is an ingredient used in some vaccines that help produce a stronger immune response in the people receiving the vaccine and thus helps the vaccine work better. This study will recruit approximately 368 participants in total and will be conducted in two stages: Stage 1 will look at two vaccinations with GBP511 when given with and without the CAS-1 adjuvant; and Stage 2 will look at either one or two vaccinations with two candidate GBP511 vaccines chosen from Stage 1 of the study. Participants will be required to attend Linear's clinical unit on two separate occasions to receive their two vaccinations. On the first day of dosing (Visit 2/Day 1) and second day of dosing (Visit 5/Day 29), we will be testing a single dose of the study drug in up to 168 healthy volunteers who will be divided into 3 groups. Group 1, Groups 2 and 3 will have 56 people each. These 3 groups will be divided into treatment subgroups, with a total of 6 test subgroups and 3 control subgroups. In all groups, neither you or the study doctor will know what subgroup you are part of, and therefore what treatment (GBP511 or Comirnaty+ placebo) you will receive.

A Phase 1 Study of Navlimetostat Tablet Formulations

This study aims to compare the PK of Navlimetostat after administration of a wet-granulation tablet versus the dry-granulation tablet formulation in healthy adult female

A Study to Evaluate Dermal Open-Flow Microperfusion and Plasma Pharmacokinetic Study of Multiple Doses of Oral Povorcitinib or Topical Ruxolitinib Cream in Healthy Adult Participants

The purpose of this study is to evaluate the interstitial concentrations using the open-flow microperfusion device and plasma pharmacokinetics following multiple doses of povorcitinib or topical ruxolitinib cream in healthy adult participants.