DDrare: Database of Drug Development for Rare Diseases

告示番号	疾患名（ページ内リンク）	臨床試験数
299	嚢胞性線維症	1

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT03056326 (ClinicalTrials.gov)	November 2016	3/2/2017	A Study to Investigate Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of CHF6333 in Healthy Subjects	A Phase I, Randomised, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of Inhaled CHF 6333 After Single and Repeated Ascending Doses in Healthy Male Subjects	Non-Cystic Fibrosis Bronchiectasis;Cystic Fibrosis	Drug: CHF6333 (Part 1 - SAD);Drug: Placebo (Part 1 - SAD);Drug: CHF6333 (Part 2 - MAD);Drug: Placebo (Part 2 - MAD)	Chiesi Farmaceutici S.p.A.	NULL	Completed	18 Years	55 Years	Male	72	Phase 1	Belgium

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT03056326
(ClinicalTrials.gov)

November 2016

3/2/2017

A Study to Investigate Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of CHF6333 in Healthy Subjects

A Phase I, Randomised, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of Inhaled CHF 6333 After Single and Repeated Ascending Doses in Healthy Male Subjects

Non-Cystic Fibrosis Bronchiectasis;Cystic Fibrosis

Drug: CHF6333 (Part 1 - SAD);Drug: Placebo (Part 1 - SAD);Drug: CHF6333 (Part 2 - MAD);Drug: Placebo (Part 2 - MAD)

Chiesi Farmaceutici S.p.A.

NULL

Completed

18 Years

55 Years

Male

Phase 1

Belgium