Creation of a database of test subjects for the preparation of a Phase I study for the development of a new drug for stroke therapy

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00036336

Enrollment

300

Registered

2025-03-06

Start date

2025-03-04

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I63.9

Interventions

Group 1: Subjects interested in participating in Phase I trials will be screened to determine their eligibility for inclusion in Phase I trials.

Eligibility

Sex/Gender

Male

Age

18 Years to 50 Years

Inclusion criteria

Inclusion criteria: - Male healthy subjects aged 18-50 years - BMI 20-30 kg/m2 - Weight > 70 kg

Exclusion criteria

Exclusion criteria: - Smoker (current nicotine consumption that cannot be interrupted for a period of at least 14 days) - Illegal drug or alcohol consumption - Individuals unable to give consent

Design outcomes

Primary

Measure	Time frame
The aim of this project is to set up and implement a subject database to facilitate the recruitment of subjects for the above-mentioned Phase I study. The planned database should contain detailed information about potential subjects to enable a quick and precise selection of study participants.	—

Secondary

Measure	Time frame
Efficiency of recruitment - Number of subjects included in the database over a certain period of time - Proportion of subjects who later actually participate in a Phase I trial - Duration from registration to first study participation Demographic and socio-cultural characteristics of the recruited subjects - Age distribution, gender ratio - Place of residence and accessibility of the study site - Motivation to participate in Phase I studies Challenges and success factors in recruitment - Reasons for rejection or non-participation despite registration - Influence of advertising measures or incentives on willingness to participate	—

Measure

Time frame

Efficiency of recruitment - Number of subjects included in the database over a certain period of time - Proportion of subjects who later actually participate in a Phase I trial - Duration from registration to first study participation Demographic and socio-cultural characteristics of the recruited subjects - Age distribution, gender ratio - Place of residence and accessibility of the study site - Motivation to participate in Phase I studies Challenges and success factors in recruitment - Reasons for rejection or non-participation despite registration - Influence of advertising measures or incentives on willingness to participate

—

Countries

Germany

Contacts

Public ContactTimo Uphaus

Universitätsmedizin Mainz

tiuphaus@uni-mainz.de+496131177156

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026