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Healthy Volunteers clinical trials

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NCT ID: NCT03615196 Completed - Healthy Volunteers Clinical Trials

Study of the Safety of USB005 in Healthy Volunteers

Start date: July 25, 2018
Phase: Phase 1
Study type: Interventional

This study will evaluate the safety, tolerability and pharmacokinetics of USB005 (aclerastide) Ophthalmic Solution.

NCT ID: NCT03610334 Completed - Healthy Volunteers Clinical Trials

A Combined SAD and MAD Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of IFB-088

Start date: June 21, 2018
Phase: Phase 1
Study type: Interventional

This is the first study of single and multiple doses of IFB-088 in human subjects. The current study is designed to assess in the first part, the safety, tolerability, plasma and urine pharmacokinetics (PK) of single oral doses of IFB-088 in healthy subjects (Single Ascending Doses - SAD) and in a second part safety, tolerability, plasma and urine pharmacokinetics (PK) of multiple oral doses of IFB-088 in healthy subjects (Multiple Ascending Doses - MAD)

NCT ID: NCT03608319 Completed - Healthy Volunteers Clinical Trials

Study of A4250 in Healthy Volunteers Under Fasting, Fed and Sprinkled Conditions

Start date: July 5, 2018
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to determine the single-dose pharmacokinetics (PK) of A4250 when administered after a high-fat meal and when sprinkled on applesauce in healthy adult subjects.

NCT ID: NCT03603431 Completed - Healthy Volunteer Clinical Trials

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MRG-110 Following Intradermal Injection in Healthy Volunteers

Start date: April 9, 2018
Phase: Phase 1
Study type: Interventional

MRG-110 is intended to promote the growth of new blood vessels by inhibiting a molecule called miR-92a. MRG-110 is being studied to determine if it can accelerate healing of wounds by improving blood flow into the wound area. The primary objective of this study is to investigate the safety and tolerability of MRG-110 when injected into the skin at the site of a small skin wound in normal healthy volunteers. Another objective is to study the pharmacokinetics of MRG-110 (the movement of a drug into, through and out of the body). Participants in the clinical trial will receive either a single dose or multiple doses of MRG-110 and/or placebo. Blood samples, urine samples and skin biopsies will be collected to measure how MRG-110 is processed by the body, and how the body responds when exposed to MRG-110.

NCT ID: NCT03603106 Completed - Healthy Volunteers Clinical Trials

Pharmacokinetics, Pharmacodynamics Profile and Tolerance of P03277 in Healthy Subjects and Patients With Brain Lesions

Start date: November 25, 2013
Phase: Phase 1/Phase 2
Study type: Interventional

The primary objective of this study was to evaluate the safety (clinical and biological) and pharmacokinetics (plasma and urine) profile of P03277 following single administration at ascending dose levels in healthy subjects.

NCT ID: NCT03593707 Completed - Healthy Volunteers Clinical Trials

Drug-Drug Interaction Study to Evaluate the Effect of PF-06865571 on Metformin Pharmacokinetics

Start date: August 17, 2018
Phase: Phase 1
Study type: Interventional

This study is designed to assess the effect of PF-06865571 administration on the pharmacokinetics of metformin in healthy adult subjects.

NCT ID: NCT03587649 Completed - Healthy Volunteers Clinical Trials

Evaluation of [18F]MNI-1126 as an Imaging Marker for Synaptic Density Loss

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

The primary objective of this protocol is to examine [18F]MNI-1126 as a tool to assess synaptic density loss.

NCT ID: NCT03586908 Completed - Healthy Volunteer Clinical Trials

PK/PD, Safety and Tolerability of PHP-201 Topical Eye Drop in Korean and Japanese Healthy Subjects

Start date: February 4, 2018
Phase: Phase 1
Study type: Interventional

An open label, multiple-dose, phase 1 clinical trial to evaluate pharmacokinetics, pharmacodynamics, safety and tolerability of PHP-201 topical eye drop in Korean and Japanese healthy subjects

NCT ID: NCT03586726 Completed - Healthy Volunteers Clinical Trials

A Study to Investigate the Effect of Rifampicin on the PK of Multiple Doses of Balovaptin In Healthy Volunteers

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

This study was a single-center, non-randomized, open-label, one-sequence, two-period, within-subject study to investigate the effects of multiple doses of rifampicin on the PK and safety of multiple doses of balovaptan in healthy subjects. The study was conducted at 1 site in the Netherlands.

NCT ID: NCT03579823 Completed - Healthy Volunteers Clinical Trials

Comparative Safety, Tolerability, Pharmacokinetic Study of AVT02 (100MG/ML) and Humira (100MG/ML) in Healthy Volunteers

ALVOPAD
Start date: May 21, 2018
Phase: Phase 1
Study type: Interventional

Adalimumab is an immunosuppressive drug that belongs to the family of anti-TNF agents. It contains a monoclonal antibody produced by biotechnology. It is designed to bind to tumor necrosis factor (TNF), a substance that is involved in several auto-immune processes. By binding to TNF, adalimumab blocks its activity, reducing the severity of various chronic inflammatory diseases including Rheumatoid Arthritis, Plaque Psoriasis and others. Often, the high cost of biologic products may preclude access to the treatment to a big portion of the population worldwide. A biosimilar product that provides comparable safety and efficacy at more affordable cost would fulfill a broader medical need. Humira has been available on the market for several years. Recently, a higher concentration (100 mg/mL) formulation has been introduced in major markets. Alvotech is developing AVT02, that is a proposed biosimilar of adalimumab containing high concentration (100 mg/mL) of active ingredient. The objective of this clinical trial is to assess the similarity of AVT02 (100 mg/mL) with Humira (100 mg/mL), in terms of tolerability, safety (including immunogenicity) and compare the pharmacokinetics in healthy volunteers.