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	2

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	EUCTR2019-003178-25-HU (EUCTR)	19/11/2019	20/11/2019	A study of safety, tolerability and effect of SNSP113 in Cystic Fibrosis	A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Effect of Inhaled SNSP113 in Adult Subjects with Cystic Fibrosis	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: SNSP113 Product Code: SNSP113 INN or Proposed INN: not assigned Other descriptive name: PAAG15	Synspira Therapeutics, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	56	Phase 2	Hungary
2	NCT03309358 (ClinicalTrials.gov)	September 28, 2017	5/10/2017	A Study of the Safety and Tolerability of Inhaled SNSP113 in Healthy Subjects and Subjects With Stable Cystic Fibrosis	A Multiple-Site, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose (SAD) Study to Assess the Safety and Tolerability of Inhaled SNSP113 in Healthy Male Subjects (Part A) and Subjects With Stable Cystic Fibrosis (Part B)	Lung Diseases;Pulmonary Disease;Cystic Fibrosis;Cystic Fibrosis Lung;Cystic Fibrosis Pulmonary Exacerbation;Cystic Fibrosis With Exacerbation;Respiratory Tract Disease;Pulmonary Inflammation;Multi-antibiotic Resistance;Antibiotic Resistant Infection;Lung Infection;Lung Infection Pseudomonal;Lung; Infection, Atypical Mycobacterium;Burkholderia Infections;Burkholderia Cepacia Infection;Lung Inflammation	Drug: Inhaled SNSP113;Drug: Inhaled Placebo	Synspira, Inc.	NULL	Terminated	18 Years	50 Years	All	32	Phase 1	United Kingdom

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

EUCTR2019-003178-25-HU
(EUCTR)

19/11/2019

20/11/2019

A study of safety, tolerability and effect of SNSP113 in Cystic Fibrosis

A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Effect of Inhaled SNSP113 in Adult Subjects with Cystic Fibrosis

Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Product Name: SNSP113
Product Code: SNSP113
INN or Proposed INN: not assigned
Other descriptive name: PAAG15

Synspira Therapeutics, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Hungary

NCT03309358
(ClinicalTrials.gov)

September 28, 2017

5/10/2017

A Study of the Safety and Tolerability of Inhaled SNSP113 in Healthy Subjects and Subjects With Stable Cystic Fibrosis

A Multiple-Site, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose (SAD) Study to Assess the Safety and Tolerability of Inhaled SNSP113 in Healthy Male Subjects (Part A) and Subjects With Stable Cystic Fibrosis (Part B)

Lung Diseases;Pulmonary Disease;Cystic Fibrosis;Cystic Fibrosis Lung;Cystic Fibrosis Pulmonary Exacerbation;Cystic Fibrosis With Exacerbation;Respiratory Tract Disease;Pulmonary Inflammation;Multi-antibiotic Resistance;Antibiotic Resistant Infection;Lung Infection;Lung Infection Pseudomonal;Lung; Infection, Atypical Mycobacterium;Burkholderia Infections;Burkholderia Cepacia Infection;Lung Inflammation

Drug: Inhaled SNSP113;Drug: Inhaled Placebo

Synspira, Inc.

NULL

Terminated

18 Years

50 Years

All

Phase 1

United Kingdom