Lutherville, Maryland Clinical Trials

A Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GNS-3545 in Healthy Participants

This is a randomized, double-blind, placebo-controlled Phase 1 study of SAD (Part 1) and MAD (Part 2) of orally administered GNS-3545 in healthy adult subjects. The food effect will be assessed in one cohort in Part 1.

K Kim Arcusa

Evaluating the Status of Complex Aneuploidy to Locate Additional Transferrable Embryos

This study aims to evaluate the reproductive potential of embryos classified as "complex aneuploid" (involving three or more abnormal chromosomes) or "chaotic" (six or more abnormal chromosomes) through preimplantation genetic testing for aneuploidy (PGT-A). Specifically, we seek to determine whether embryos initially reported as having multiple chromosomal abnormalities might still …

Cantharidin Application in Patients With Common Warts (Verruca Vulgaris) (COVE-2)

This is a Phase 3, double-blind, randomized, vehicle-controlled study (Study number VP-CW-301; referred to as COVE-2 \[Cantharidin and Occlusion in Verruca Epithelium\]) to evaluate the efficacy and safety of YCANTH (VP-102) treatment in subjects with common warts.

M MD, MPH, FACP

Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BGM1812 Injection Following Single and Multiple Subcutaneous Administration in Normal to Overweight or Obese But Otherwise Healthy Men and Women

This is a Phase 1, single-center, double-blind, placebo-controlled, dose-escalation study. The study will evaluate the pharmacokinetics (PK), pharmacodynamic (PD), preliminary efficacy, safety and tolerability of BGM1812 following single and multiple SC administrations in normal to overweight or obese but otherwise healthy subjects.

Study to Evaluate the Safety & Tolerability of MRT5005 Administered by Nebulization in Adults With Cystic Fibrosis

This Phase 1/2, first-in-human study will evaluate the safety and tolerability of single and multiple escalating doses of MRT5005 administered by nebulization to the respiratory tract of adult subjects with CF.

L Lisa Bendy, BA

Restarting Triple Therapy With Robust Monitoring for Adverse Events (RETRIAL)

RETRIAL is a multi-site observational study of people with Cystic Fibrosis (PWCF) ages 6 and up starting the new triple-therapy modulator (vanzacaftor/tezacaftor/deutivacaftor (VTD)), after having experienced neuropsychiatric events and/or liver injury while taking elexacaftor/tezacaftor/ivacaftor (ETI) that resulted in a modification or discontinuation of standard ETI dosing.

Evaluation of RBS2418 in Combination With Tremelimumab Plus Durvalumab in Participants With Advanced Unresectable Hepatocellular Carcinoma

RBS2418 is a targeted immune modulator that inhibits ectonucleotide pyrophosphatase/phosphodiesterase 1 (ENPP1). It is designed to promote anti-tumor immunity by preserving endogenous 2'-3' cyclic guanosine monophosphate-adenosine monophosphate (cGAMP) from hydrolysis, thereby activating antigen-presenting cells and promoting robust T cell activation. Ideally, RBS2418 acts synergistically with CTLA-4 inhibitors, such as those …

H Hanna Smith

Tocilizumab Discontinuation Versus Dose Reduction for Patients With Well-Controlled Giant Cell Arteritis

This is a multi-center, randomized, open label study that will assess the efficacy and safety of ACTEMRA(R) or one of its FDA-approved biosimilars Tocilizumab (TCZ) maintenance versus withdrawal in Giant cell arteritis (GCA) patients who are in remission after at least 12 months of high dose TCZ treatment. Eligible participants …

C Chenchen Zhang

RNA Sequencing of Discarded Tracheal Stenosis Tissue to Characterize Cellular and Molecular Pathogenesis

Benign tracheal stenosis is a rare but potentially life-threatening condition, typically resulting from fibroinflammatory scarring. It can be secondary to iatrogenic etiologies such as intubation or tracheostomy , as well as autoimmune diseases and being idiopathic. Patients typically undergoes endoscopic or surgical interventions to open up the airways. This project …

K Katherine H. Tkaczuk

Metabotyping of Broccoli Microgreen in Obese Breast Cancer Survivors

Obesity can pose significant challenges to maintaining long-term health in cancer survivors by increasing their risk of cancer coming back. Eating a healthy diet is an important way to help manage weight and improve overall health. Broccoli microgreens (BMG) are young broccoli plants packed with nutrients, and research suggests they …