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Neuropharmacologic Imaging and Biomarker Assessments of Response to Acute and Repeated-Dosed Ketamine Infusions in Major Depressive Disorder
Background: Most medications that treat depression take weeks or months to work. Researchers want to develop fast-acting treatments. One dose of ketamine has …
Recruitment and Characterization of Healthy Research Volunteers for NIMH Intramural Studies
Objective: To screen and create a list of adult volunteers in good health for participation in research studies conducted at the National Institutes of Health …
A Phase 1, Double-Blind, Placebo-Controlled, Randomized, Single and Multiple Ascending Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SIF001 in Healthy Subjects and in a Patient Cohort With Epilepsy
This is a dose escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of SIF001, a monoclonal antibody with the potential t…
A Phase 1, Open-label, Single Dose, Crossover Study to Assess the Relative Bioavailability of Emraclidine Formulations in Healthy Adult Subjects
The objective of this study is to evaluate the pharmacokinetics (PK) and relative bioavailability of emraclidine following single oral administration of differ…
A Phase 1, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Pharmacokinetics of Inhaled TRL1068 in Healthy Volunteers
This study in healthy volunteers will provide a basis for evaluation of inhaled TRL1068 as a first in human study, specifically, important safety, tolerability…
A Phase 1/2, Randomized, Double-blind, Placebo-controlled 2-part Study of the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Single Dose ALN-4324 in Overweight to Obese Adult Healthy Volunteers and Multiple Dose ALN-4324 in Overweight to Obese Patients With Type 2 Diabetes Mellitus (T2DM)
The purpose of this study is to: * evaluate the safety and tolerability of single ascending doses of ALN-4324 in healthy volunteers and to characterize the si…
Variability In Mixed Meal Tests: Fixed Versus Adjusted to Energy Needs Caloric Dose
Background: Researchers use mixed meal tolerance tests (MMTTs) to look at how people s bodies respond to eating a meal. However, researchers do not agree on h…
A Phase 1, Multi-center, Open-label, Single-dose Study to Assess the Pharmacokinetics and Safety of BMS-986435 in Participants With Normal Hepatic Function and Participants With Mild and Moderate Hepatic Impairment
The purpose of this study is to determine the pharmacokinetic and safety of BMS-986435 in participants with normal hepatic function and participants with diffe…
A Phase 3, Randomized, Modified Double-blind, Active-controlled, Parallel-group, Lot-to-lot Consistency, 4-arm Study to Investigate the Safety and Immunogenicity of a 4-dose Regimen of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants and Toddlers
This is a phase 3 randomized, modified double-blind study whose purpose is to measure whether 3 lots of the investigational pneumococcal vaccine PCV21 can help…
A First in Human, Single Ascending Dose Study of ABBV-1451 to Evaluate the Pharmacokinetics, Immunogenicity, Safety, and Tolerability in Healthy Subjects and in Japanese and Han Chinese Healthy Subjects
The objective of this study is to assess the pharmacokinetic (PK), immunogenicity, safety, and tolerability of ABBV-1451 after single ascending doses in health…
A Phase 1, Randomized, Placebo-controlled Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Emraclidine Following Multiple Ascending Oral Doses in Healthy Elderly Subjects
This study is to assess how oral emraclidine moves through the body of healthy elderly adult participants, and assess adverse events, and tolerability.
Novel Biomarkers of Non-IgE Immediate Hypersensitivity Drug Reactions
The goal of this clinical trial is to investigate biomarkers of non-IgE-mediated immediate hypersensitivity reactions during infusion of intravenous vancomycin…