Other Clinical Trial - Study to Evaluate the Pharmacokinetic

Study to Evaluate the Pharmacokinetic Characteristics, Safety, Tolerability, and Preliminary Efficacy of 9MW1911 in Patients With Chronic Obstructive Pulmonary Disease (COPD).

Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:
A Randomized, Double-Blind, Placebo-Controlled Phase Ib/IIa Clinical Study to Evaluate the Pharmacokinetic Characteristics, Safety, Tolerability, and Preliminary Efficacy of 9MW1911 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Lung Diseases
Lung Diseases, Obstructive
Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Pulmonary Disease, Chronic Obstructive

See also
	Status	Clinical Trial	Phase
	Completed	`NCT01584505` - Phase II Study to Evaluate the Cardiac Safety of 2 Doses of CHF5993 Both Combined With CHF1535 BID Versus CHF1535 BID in Patients With Moderate to Severe COPD	Phase 2

See also

Status

Clinical Trial

Phase

Completed

NCT01584505 - Phase II Study to Evaluate the Cardiac Safety of 2 Doses of CHF5993 Both Combined With CHF1535 BID Versus CHF1535 BID in Patients With Moderate to Severe COPD

Phase 2

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	NCT06175351
Study type	Interventional
Source	Mabwell (Shanghai) Bioscience Co., Ltd.
Contact
Status	Recruiting
Phase	Phase 1/Phase 2
Start date	July 6, 2023
Completion date	September 30, 2025

Study to Evaluate the Pharmacokinetic Characteristics, Safety, Tolerability, and Preliminary Efficacy of 9MW1911 in Patients With Chronic Obstructive Pulmonary Disease (COPD).

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms