Clinical trial • Phase I • Dermatology
CXCL12 (expressed by Lactobacillus) for Wound healing | Skin wounds
Phase I trial of CXCL12 (expressed by Lactobacillus) for Wound healing | Skin wounds.
Overview
- Trial Therapeutic Area
- Dermatology
- Trial Disease
- Wound healing | Skin wounds
- Trial Stage
- Phase I
- Drug Modality
- Other
Key dates
- Initial CTIS Submission Date
- 28-10-2024
- First CTIS Authorization Date
- 26-11-2024
Trial design
Randomised, placebo (topical); dose and schedule not specified-controlled, adaptive Phase I trial across 1 site in Sweden.
- Randomised
- Yes
- Comparator
- Placebo (topical); dose and schedule not specified
- Adaptive
- Yes
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 36
Eligibility
Recruits 36 No vulnerable population selected; trial population: Healthy volunteers; no consent or assent handling details provided..
- Vulnerable Population
- No vulnerable population selected; trial population: Healthy volunteers; no consent or assent handling details provided.
Recruitment
- Planned Sample Size
- 36
- Recruitment Window Months
- 76
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 36
Sweden
- Earliest CTIS Part Ii Submission Date
- 15-11-2024
- Latest Decision Or Authorization Date
- 26-11-2024
- Processing Time Days
- 11
- Number Of Sites
- 1
- Number Of Participants
- 36
Sites
- Site Name
- CTC Clinical Trial Consultants AB
- Department Name
- Uppsala University Hospital
- Contact Person Name
- Helena Litorp
- Contact Person Email
- helena.litorp@ctc-ab.se
- Number Of Participants
- 36
Sponsor
Primary sponsor
- Full Name
- Ilya Pharma AB (publ)
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Sweden
Investigational products
- Investigational Product Name
- Lactobacillus expressing CXCL12
- Active Substance
- CXCL12 (expressed by Lactobacillus)
- Modality
- Other
- Routes Of Administration
- Topical
- Route
- Topical
- Authorisation Status
- Investigational (not authorised)
- First In Human
- Yes
- Dose Escalation Increase
- Single and multiple ascending dose design planned; specific dose levels not specified
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