Clinical trial • Phase I • Immunology

ZP9830 for Autoimmune diseases

Phase I trial of ZP9830 for Autoimmune diseases. None/Not specified-controlled. 124 participants.

Overview

Trial Therapeutic Area
Immunology
Trial Disease
Autoimmune diseases
Trial Stage
Phase I

Key dates

Initial CTIS Submission Date
19-08-2024
First CTIS Authorization Date
28-10-2024

Trial design

None/Not specified-controlled Phase I trial across 1 site in Netherlands.

Comparator
None/Not specified
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
124

Eligibility

Recruits 124 Vulnerable population not selected; trial population: Healthy volunteers; no specific consent/assent handling for vulnerable groups described in the record..

Vulnerable Population
Vulnerable population not selected; trial population: Healthy volunteers; no specific consent/assent handling for vulnerable groups described in the record.

Recruitment

Planned Sample Size
124
Recruitment Window Months
19

Geography

Total Number Of Sites
1
Total Number Of Participants
124

Netherlands

Earliest CTIS Part Ii Submission Date
17-10-2024
Latest Decision Or Authorization Date
10-10-2025
Processing Time Days
358
Number Of Sites
1
Number Of Participants
124

Sites

Site Name
Centre for Human Drug Research
Department Name
Immunology
Contact Person Name
Matthijs Moerland
Contact Person Email
clintrials@chdr.nl
Number Of Participants
124

Sponsor

Primary sponsor

Full Name
Zealand Pharma A/S
Organisation Type
Pharmaceutical company
Country Of Registered Address
Denmark

Investigational products

Investigational Product Name
ZP9830

Related trials

Other published trials that may interest you.