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Healthy Volunteers clinical trials

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NCT ID: NCT03546465 Completed - Healthy Volunteers Clinical Trials

Safety, Tolerability, Pharmacokinetics & Pharmacodynamics Study of Ropeginterferon Alfa-2b in Healthy Japanese and Caucasian Subjects

Start date: May 7, 2018
Phase: Phase 1
Study type: Interventional

This is a Phase 1 single center, parallel group study to assess and compare the safety, tolerability, PK and PD of 4 single ascending doses of P1101 (100, 200, 300, and 450 μg) following subcutaneous administration in healthy Japanese and Caucasian subjects.

NCT ID: NCT03545789 Completed - Healthy Volunteers Clinical Trials

Phase 1 Test-retest Evaluation of [18F]MNI-958 PET

Start date: March 12, 2018
Phase: Phase 1
Study type: Interventional

The overall goal of this protocol is to evaluate [18F]MNI-958 also known as APN-0000455 or PM-PBB3, a tau targeted radiopharmaceutical.

NCT ID: NCT03542435 Completed - Healthy Volunteers Clinical Trials

Randomized, Double-Blind, Placebo-Controlled, MAD Study to Assess the Safety, Tolerability, and Pharmacokinetics of SXC 2023

Start date: April 26, 2018
Phase: Phase 1
Study type: Interventional

This is a randomized, double-blind, placebo-controlled, multiple ascending dose study conducted at one study center in the United States. Safety and tolerability will be assessed throughout the study and serial blood samples and urine samples will be collected for the safety and pharmacokinetic assessment of SXC-2023.

NCT ID: NCT03538600 Recruiting - Healthy Volunteers Clinical Trials

Sample Collection From Healthy Volunteers for Assay Optimization

Start date: June 28, 2018
Phase:
Study type: Observational

Background: The Laboratory of Immune System Biology (LISB) works with other labs at the National Institutes of Health. They study how parts of living things come together to make a whole. LISB designs and improves research tests on human samples like blood and cells. In order to do its work, LISB needs to have a lot of these samples available. Objective: To collect biological specimens to use for designing and improving research tests. Specimens include blood, stool, saliva, and skin/mucosal swabs. Eligibility: Healthy people ages 18-80 Design: Participants will be screened with an interview about their general health and their medical history. They will have a physical exam and blood tests. If the results of the screening are normal, participants will be asked to give one or more of these samples: Blood will be drawn from an arm vein with a needle and syringe. Mucus and skin will be collected by rubbing the area with a cotton swab. The areas may include the top of the tongue, inside the cheek, nostrils, behind the ear, elbow pit, or vagina. Participants will spit into a tube to collect saliva. Participants will pass stool into a plastic container that fits in the toilet under the seat. They will get sampling kits and instructions. Over the next 5 years, if more samples are needed, participants will be contacted to set up another visit to the NIH. These visits will each take about 1 hour. About every 2 years, when participants come to NIH for a visit, extra blood will be collected. It will be tested for HIV and hepatitis B and C.

NCT ID: NCT03537508 Completed - Clinical trials for Healthy Volunteers (Meningococcal Infection)

Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the US

Start date: April 25, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the immunogenicity and describe the safety of MenACYW conjugate vaccine and MENVEO® when both are administered concomitantly with routine pediatric vaccines to healthy infants and toddlers in the US.

NCT ID: NCT03535129 Recruiting - Healthy Volunteers Clinical Trials

A Response Modulation Hypothesis of Socioemotional Processing Associated With Alcohol Use Disorder

Start date: September 20, 2018
Phase: N/A
Study type: Interventional

Background: Problem drinking affects nearly half the people who drink alcohol. Drinking alcohol affects a person s social behavior and brain structure, but researchers don t have a good understanding of how. They want to test a technique called neurofeedback to learn more about how to treat problem drinking. Objectives: To study what happens in the brains of people who drink alcohol when they look at pictures of social things and of alcohol. To learn if people can control brain activity in a magnetic resonance imaging (MRI) scanner and if this helps people with drinking. Eligibility: Adults ages 21 65 who have an alcohol use disorder. Healthy volunteers ages 21 65 Design: Participants will be screened with Physical exam Medical history Blood, urine, and heart tests Mental health interview Questions about their alcohol drinking. At each session, participants will have: A urine test for drugs and pregnancy. If they test positive, they cannot participate. A breath alcohol test and assessment for alcohol withdrawal. Participants will complete surveys, talk to researchers about behaviors, and play games. Participants will have MRI brain scans. The scanner is a metal cylinder in a strong magnetic field. They will lie on a table that slides in and out of the scanner for 1 2 hours. Participants will do tasks in the scanner: They will look at pictures, sometimes of alcohol. They will try to hit a goal. Some participants will get feedback during this task. They will see how their brain activity changes or how someone else s changes. Participants may have follow-up phone questions at least 3 times over about 6 months.

NCT ID: NCT03533387 Completed - Healthy Volunteers Clinical Trials

Study of MN-166 (Ibudilast) Extended Release Tablet Formulations Compared With Capsules in Healthy Volunteers

Start date: April 11, 2018
Phase: Phase 1
Study type: Interventional

To compare the bioavailability and pharmacokinetic profiles of two different formulations MN-166 50mg, extended release (ER) tablets with MN-166 10mg capsules in a single-dose regimen in healthy volunteers

NCT ID: NCT03530514 Completed - Healthy Volunteers Clinical Trials

A Study to Examine the Safety, Tolerability and Biological Effects of REGN4461 in Healthy Volunteers

Start date: April 24, 2018
Phase: Phase 1
Study type: Interventional

The primary objective of the study is to evaluate the safety and tolerability of REGN4461 in healthy participants. The secondary objectives of the study are to: - Characterize the Pharmacokinetic (PK) profile of single and repeated doses of REGN4461 and evaluate the effects of baseline covariates on PK profile - Estimate the effects of repeated doses of REGN4461 on body weight over 12 weeks in overweight and obese participants - Assess the effects of repeated doses of REGN4461 on ad lib energy intake in overweight and obese participants - Evaluate the effects of single and repeated doses of REGN4461 on soluble forms of lipid-regulating proteins levels over time - Assess the immunogenicity of single and repeated doses of REGN4461

NCT ID: NCT03526744 Completed - Healthy Volunteers Clinical Trials

Marine Protein Hydrolysate as Dietary Supplement in Elderly Part II

MPH-DR
Start date: April 27, 2018
Phase: N/A
Study type: Interventional

The aim of this study is to investigate the potential effect of different doses of MPH supplement on glucose metabolism, hunger and appetite hormones.

NCT ID: NCT03525119 Completed - Healthy Volunteers Clinical Trials

Immunogenicity and Safety of Tetravalent Dengue Vaccine (TDV) Co-administered With an Hepatitis A Virus Vaccine

Start date: May 16, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to investigate the immunogenicity and safety of the concomitant administration of TDV (subcutaneous [SC] injection) and of hepatitis A virus (HAV) vaccine (intramuscular [IM] injection) in healthy participants aged 18 to 60 years living in country(ies) non-endemic for both dengue and hepatitis.