Clinical trial • Phase I • Other
OPT101 for Chronic kidney disease | Chronic kidney disease stage 4 | Chronic kidney disease stage 5
Phase I trial of OPT101 for Chronic kidney disease | Chronic kidney disease stage 4 | Chronic kidney disease stage 5. adaptive. 12 participants.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Chronic kidney disease | Chronic kidney disease stage 4 | Chronic kidney disease stage 5
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 10-09-2025
- First CTIS Authorization Date
- 09-01-2026
Trial design
adaptive Phase I trial across 1 site in Latvia.
- Adaptive
- True, single ascending dose escalation design referenced in title ('single ascending concentrations'); specific dose-escalation rules, interim analyses or stopping rules not provided in source.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 12
Eligibility
Recruits 12 Vulnerable population not selected; no specific consent or assent handling described..
- Vulnerable Population
- Vulnerable population not selected; no specific consent or assent handling described.
Recruitment
- Planned Sample Size
- 12
- Recruitment Window Months
- 3
- Consent Approach
- Not described in source documents; no details on informed consent, assent, age-specific documents, or languages available.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 12
Latvia
- Earliest CTIS Part Ii Submission Date
- 28-11-2025
- Latest Decision Or Authorization Date
- 09-01-2026
- Processing Time Days
- 42
- Number Of Sites
- 1
- Number Of Participants
- 12
Sites
- Site Name
- Pauls Stradins Clinical University Hospital
- Department Name
- NEPHROLOGY CENTRE
- Contact Person Name
- Aivars Petersons
- Contact Person Email
- nefropa@latnet.lv
- Number Of Participants
- 12
Sponsor
Primary sponsor
- Full Name
- OPTERION Health AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Investigational products
- Investigational Product Name
- OPT101
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