Clinical trial • Phase I • Neurology
SZV-1287 for Neuropathic pain
Phase I trial of SZV-1287 for Neuropathic pain. Placebo; dose/schedule not specified.-controlled, adaptive. 68 participants.
Overview
- Trial Therapeutic Area
- Neurology
- Trial Disease
- Neuropathic pain
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 06-11-2024
- First CTIS Authorization Date
- 25-11-2024
Trial design
Placebo; dose/schedule not specified.-controlled, adaptive Phase I trial across 1 site in Hungary.
- Comparator
- Placebo; dose/schedule not specified.
- Adaptive
- True, single ascending dose (SAD) and multiple ascending dose (MAD) escalation design; specific escalation rules, interim analyses, and stopping rules not provided in the record.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 68
Eligibility
Recruits 68 No vulnerable populations selected; participants are healthy adult male volunteers. Informed consent is to be obtained from participants. No assent or other vulnerable-population consent details are provided..
- Vulnerable Population
- No vulnerable populations selected; participants are healthy adult male volunteers. Informed consent is to be obtained from participants. No assent or other vulnerable-population consent details are provided.
Recruitment
- Planned Sample Size
- 68
- Recruitment Window Months
- 46
- Consent Approach
- Informed consent to be obtained from adult male participants (healthy volunteers). No details provided on assent, age-specific consent documents, or languages available.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 68
Hungary
- Earliest CTIS Part Ii Submission Date
- 20-11-2024
- Latest Decision Or Authorization Date
- 16-04-2025
- Processing Time Days
- 147
- Number Of Sites
- 1
- Number Of Participants
- 68
Sites
- Site Name
- DRC Kft.
- Department Name
- Phase I
- Contact Person Name
- Botond Literati-Nagy
- Contact Person Email
- sc@drc.hu
- Number Of Participants
- 68
Sponsor
Primary sponsor
- Full Name
- University Of Pecs
- Organisation Type
- Educational Institution
- Country Of Registered Address
- Hungary
Investigational products
- Investigational Product Name
- SZV-1287
- Routes Of Administration
- Oral
- Route
- Oral
- Dose Levels
- Single ascending dose and multiple ascending doses (14 days)
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