An adaptive, randomized, double-blind, single-center, placebo-controlled first-in-human study evaluating safety, tolerability and exposure of single and multiple ascending doses of Lactobacillus expressing CXCL12 administered topically to experimentally induced skin wounds

2024-518698-32-00 Protocol IP-CT-001 Human pharmacology (Phase I) - First administration to humans Authorised, recruitment pending

Status Authorised, recruitment pending · 1 EU/EEA countries · 1 sites · Protocol IP-CT-001

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - First administration to humans
Status Authorised, recruitment pending
Participants planned 36
Countries 1
Sites 1

Wound healing

Key facts

Sponsor
Ilya Pharma AB (publ)
Participant type
Healthy volunteers
Age range
18-64 years
Gender
Male and Female
Therapeutic area
Not possible to specify
Decision date (initial)
2024-11-26
Transition trial
Yes
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No

External identifiers

EU CT number
2024-518698-32-00
EudraCT number
2019-000680-24

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Wound healing

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Ilya Pharma AB (publ)

Sponsor organisation
Ilya Pharma AB (publ)
Address
Dag Hammarskjolds Vag 30, Uppsala Domkyrkofors. Uppsala Domkyrkofors.
City
Uppsala
Postcode
752 37
Country
Sweden

Scientific contact point

Organisation
Ilya Pharma AB (publ)
Contact name
Evelina Vågesjö

Public contact point

Organisation
Ilya Pharma AB (publ)
Contact name
Evelina Vågesjö

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Sweden Authorised, recruitment pending 36 1
Rest of world 0

Investigational sites

Sweden

1 site · Authorised, recruitment pending
CTC Clinical Trial Consultants AB
Uppsala University Hospital, Dag Hammarskjolds Vag 10b, Uppsala Domkyrkofors., Uppsala

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-10-28 Sweden Acceptable
2024-11-26
2024-11-26