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Healthy Volunteers clinical trials

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NCT ID: NCT05201092 Recruiting - Healthy Volunteers Clinical Trials

A Study Investigating Lu AG06466 in Healthy Men

Start date: January 5, 2022
Phase: Phase 1
Study type: Interventional

The purpose of this study is to investigate how the drug Lu AG06466 is absorbed, metabolized, and excreted from the body, for example, what the body does to the drug after swallowing a single dose.

NCT ID: NCT05200169 Completed - Healthy Volunteers Clinical Trials

Mass Balance Recovery, Metabolite Profile and Metabolite Identification of 14C-AB1010 in Healthy Male Subjects

Start date: July 31, 2017
Phase: Early Phase 1
Study type: Interventional

To assess the mass balance recovery after a single oral dose of 14C-AB1010

NCT ID: NCT05196061 Recruiting - Healthy Volunteers Clinical Trials

Human Skin and Gut Mycobiome and Bacteriome Comprehensive Registry

Start date: January 1, 2020
Phase:
Study type: Observational [Patient Registry]

Bacterial and fungal microbiota will be different between individual body sites; however, particular microbiome profiles both whole-body and site-specific will be unique to volunteers with a given parameter such as medical diagnosis, diet, medications taken, geographical area; etc.

NCT ID: NCT05195723 Not yet recruiting - Healthy Volunteer Clinical Trials

Study to Assess the Safety and Pharmacokinetics of WP1122 in Healthy Volunteers

Start date: January 15, 2022
Phase: Phase 1
Study type: Interventional

This study in healthy human volunteers will investigate the effects of a single dose (SAD) and multiple days of dosing (MAD) of WP1122 administered as an oral (PO) solution. Dose escalation will take place in sequential SAD cohorts, and MAD will start as soon as SAD has completed at least 3 dosing cohorts in which WP1122 is found to be safe and well-tolerated. This study in healthy volunteers will explore safety and PK, and subsequent clinical development will be in patients infected with SARS CoV-2 in the setting of continued safety and favorable risk/benefit.

NCT ID: NCT05195008 Not yet recruiting - Healthy Volunteer Clinical Trials

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics, With Target Occupancy Study of BIIB113 in Healthy Participants

Start date: February 10, 2022
Phase: Phase 1
Study type: Interventional

Parts A and B: The primary objective of this study is to evaluate the safety and tolerability of single and multiple ascending oral doses of BIIB113 in healthy participants. The secondary objectives of this study are to evaluate the single and multiple oral dose pharmacokinetic (PK) profile of BIIB113 in healthy participants and to evaluate the effect of food on the single oral dose of BIIB113 in healthy participants of Part A cohort 3. Part C: The primary objectives of this study are to evaluate the safety and tolerability of single and multiple ascending oral doses of BIIB113 in healthy participants and to determine target occupancy (TO) as measured by O-GlcNAcase-Positron Emission Tomography (OGA-PET) of single and multiple oral doses of BIIB113 in healthy participants.

NCT ID: NCT05194579 Not yet recruiting - Healthy Volunteers Clinical Trials

Pharmacokinetic Comparability Study in Healthy Participants - PF-06881894 On-Body Injector Relative to Prefilled Syringe

Start date: February 8, 2022
Phase: Phase 1
Study type: Interventional

This will be an open-label, randomized, 2-treatment, 2-period, crossover single-dose study in approximately 134 healthy adult participants. Participants will be randomized into 2 sequences of treatment as described in the following table of Intervention Groups and Duration.

NCT ID: NCT05192369 Active, not recruiting - Healthy Volunteers Clinical Trials

A Randomized Study to Evaluate the Effects of CTP-543 on the QT/QTc Intervals in Health Volunteers

Start date: January 4, 2022
Phase: Phase 1
Study type: Interventional

This is a four-arm, randomized, crossover, placebo and active controlled study to evaluate of the effect of therapeutic and supratherapeutic doses of CTP-543 on the QT/QTc intervals in healthy volunteers

NCT ID: NCT05188638 Recruiting - Healthy Volunteers Clinical Trials

Safety of Ascending Single and Multiple Doses of Nebulised SoftOx Inhalation Solution in Healthy Subjects

Start date: October 8, 2021
Phase: Phase 1
Study type: Interventional

Background: This first-in-human study will investigate the safety and tolerability of single and multiple doses of nebulised SoftOx Inhalation Solution (SIS) delivered via a jet nebuliser to healthy subjects. Objectives: The objective of the current study is to assess the safety and tolerability of single and multiple ascending doses of nebulised SIS in healthy subjects. Eligibility: Subjects are eligible to participate in this study if they are healthy, between 18 and 55 years of age, and have a Body Mass Index (BMI) of ≥ 18.5 and ≤ 29.9 kg/m2. Subjects are not eligible to participate in this study if they have recently participated in another clinical trial or have donated blood, have a medical condition or a history of drug hypersensitivity, are using concomitant medication, or have a positive drugs of abuse test. Design: A randomised, double-blind, and placebo-controlled trial. Subjects will be enrolled into one of three single dose groups or into one of four multiple dose groups. The two first multiple dose groups will be dosed once daily (OD) for five days. The two last multiple dose groups will be dosed twice daily (BID) for four days plus a morning dose on Day 5, or four times daily (QID) for four days plus a morning dose on Day 5, respectively. The investigational medicinal product (SIS or placebo; IMP) will be delivered via a jet nebuliser and inhaled through a mask over a period of up to 15 minutes. Each treatment group will comprise eight subjects who will be randomised to receive SIS or placebo in a 3:1 ratio. A Safety Monitoring Committee (SMC) will review the safety and tolerability data from all preceding groups and decide whether the planned next dose regimen is acceptable prior to initiating the dosing in a new dose group. The dose to be administered in the multiple dose groups will depend on the results obtained in the single dose groups and will be decided by the SMC. The dose tested in the first multiple dose group will be the second highest well-tolerated single dose or lower.

NCT ID: NCT05188261 Not yet recruiting - Healthy Volunteers Clinical Trials

A Study of Single Ascending Doses of IW-3300 in Healthy Volunteers

Start date: January 2022
Phase: Phase 1
Study type: Interventional

This is a first-in-human study to evaluate the safety and tolerability of single ascending doses of IW-3300. The study drug will be administered rectally as a low-volume (20 mL) enema. Study participants will be randomized in a 3:1 ratio to receive a single dose of IW-3300 or placebo. Up to 5 different doses of IW-3300 will be studied. Safety reviews will be conducted before proceeding to each higher dose.

NCT ID: NCT05184218 Not yet recruiting - Healthy Volunteers Clinical Trials

Evaluation of IGM-6268 in Healthy Adults and Patients With Mild to Moderate COVID-19

Start date: January 20, 2022
Phase: Phase 1
Study type: Interventional

This is a Phase 1, multi-center, randomized, double-blinded, placebo-controlled study to assess the safety, tolerability, and pharmacokinetics (PK) of IGM-6268 administered intranasally and intraorally in healthy volunteers and in outpatients with mild-moderate COVID-19. IGM-6268 or placebo will be administered by intranasal + intraoral spray using a Teleflex Mucosal Atomization Device Nasal™ Intranasal Mucosal Atomization Device once, or once or twice each day for 5 days.