A Study to Compare the PK, PD & Safety & Tolerability of a SC With an IV

See also
Status	Clinical Trial	Phase
Completed	`NCT04688008` - Relative Bioavailability of Early Phase and Late Phase Hetrombopag Olamine Formulations	Phase 1
Completed	`NCT03972462` - NPC-12G Gel 0.2% Sirolimus PK Bridging Study	Phase 1
Withdrawn	`NCT02883439` - Study to Analyse Difference in Bioavailability Between MP29-02 and Fluticasone Propionate	N/A

See also

Status

Clinical Trial

Phase

Completed

NCT04688008 - Relative Bioavailability of Early Phase and Late Phase Hetrombopag Olamine Formulations

Phase 1

Completed

NCT03972462 - NPC-12G Gel 0.2% Sirolimus PK Bridging Study

Phase 1

Withdrawn

NCT02883439 - Study to Analyse Difference in Bioavailability Between MP29-02 and Fluticasone Propionate

N/A

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT03334084
Study type	Interventional
Source	argenx BVBA
Contact
Status	Completed
Phase	Phase 1
Start date	October 11, 2017
Completion date	September 19, 2018

A Study to Compare the PK, PD and Safety and Tolerability of a SC With an IV Formulation of ARGX-113 in Healthy Male Subjects

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms