A two-part, open-label study to assess the pharmacokinetics, pharmacodynamics and safety of single doses of inhaled and intravenously administered D,L lysine acetylsalicylate • glycine (LASAG) in healthy adult subjects: Study Part A follows a randomized, cross-over design to compare three dose levels of inhaled LASAG to one dose level of intravenously administered LASAG and Study Part B follows a single group design to investigate a XXXXX LASAG inhalation solution.

2022-503037-63-00 Protocol ASPI-AAP-006-01 Human pharmacology (Phase I) - Other Ended

Start 17 Aug 2023 · End 21 Feb 2024 · Status Ended · 1 EU/EEA countries · 2 sites · Protocol ASPI-AAP-006-01

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Other
Status Ended
Participants planned 28
Countries 1
Sites 2

Phase I, Clinical trial in healthy males and females intended indication: migraine

Key facts

Sponsor
Aspiair GmbH
Participant type
Healthy volunteers
Age range
18-64 years
Gender
Male and Female
Therapeutic area
Diseases [C] - Nervous System Diseases [C10], Diseases [C] - Pathological Conditions, Signs and Symptoms [C23]
Trial duration
17 Aug 2023 → 21 Feb 2024
Decision date (initial)
2023-05-19
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

Phase I, Clinical trial in healthy males and females intended indication: migraine

VersionLevelCodeTermSystem organ class
21.1 LLT 10010108 Common migraine 10029205

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Aspiair GmbH

Sponsor organisation
Aspiair GmbH
Address
Wohraer Strasse 37
City
Gemuenden (wohra)
Postcode
35285
Country
Germany

Scientific contact point

Organisation
Aspiair GmbH
Contact name
Sebastian Canisius

Public contact point

Organisation
Aspiair GmbH
Contact name
Karlheinz Nocker

Locations

1 EU/EEA country · 2 investigational sites

By country

CountryMS statusPlanned subjectsSites
Germany Ended 28 2
Rest of world — 0 —

Investigational sites

Germany

2 sites · Ended
Nuvisan GmbH
Clinic, Wegenerstrasse 13, Ludwigsfeld, Neu-Ulm
Nuvisan GmbH
Clinic, Robert-Koch-Allee 29, 82131, Gauting

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Germany 2023-08-17 2024-02-21 2023-08-17 2024-02-15

Application history

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

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2023-02-17 Germany Acceptable
2023-05-17
 2023-05-19
2 NON SUBSTANTIAL MODIFICATION NSM-3 2024-02-01 Germany Acceptable
2023-05-17
 2024-02-01