A double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of briquilimab in participants with allergic asthma.

2024-516164-28-00 Protocol JSP-CP-012 Human pharmacology (Phase I) - Other Ended

End 5 Dec 2024 · Status Ended · 1 EU/EEA countries · 3 sites · Protocol JSP-CP-012

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Other
Status Ended
Participants planned 30
Countries 1
Sites 3

allergic asthma

Key facts

Sponsor
Jasper Therapeutics Inc.
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Respiratory Tract Diseases [C08]
Trial duration
completed 5 Dec 2024
Decision date (initial)
2024-10-24
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

allergic asthma

VersionLevelCodeTermSystem organ class
21.1 LLT 10001705 Allergic asthma 10038738

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Jasper Therapeutics Inc.

Sponsor organisation
Jasper Therapeutics Inc.
Address
2200 Bridge Parkway Suite 102
City
Redwood City
Postcode
94065-1186
Country
United States

Scientific contact point

Organisation
Jasper Therapeutics Inc.
Contact name
Edwin Tucker

Public contact point

Organisation
Jasper Therapeutics Inc.
Contact name
Patricia Carlos

Locations

1 EU/EEA country · 3 investigational sites

By country

CountryMS statusPlanned subjectsSites
Germany Ended 8 3
Rest of world
Canada
22

Investigational sites

Germany

3 sites · Ended
Velocity Clinical Research Grosshansdorf GmbH
N/A, Woehrendamm 80, 22927, Grosshansdorf
The Fraunhofer Institute For Toxicology And Experimental Medicine ITEM
N/A, Nikolai-Fuchs-Strasse 1, Gross Buchholz, Hanover
IKF Pneumologie GmbH & Co. KG
Clinical Research Centre, Respiratory Medicine, Helix Medical Excellence Center, Haifa-Allee 24, Bretzenheim, Mainz

Application history

2 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-07-18 Germany Acceptable
2024-10-23
2024-10-24
2 NON SUBSTANTIAL MODIFICATION NSM-1 2024-11-07 Germany Acceptable
2024-10-23
2024-11-07