A phase 1 trial evaluating the absorption, safety and tolerability of imlifidase after a single dose in healthy Japanese men
| ISRCTN | ISRCTN45338135 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45338135 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 1005630 |
| Protocol serial number | IRAS 1005630, PXL 272092 |
| Sponsor | Hansa Biopharma (Sweden) |
| Funder | Hansa Biopharma AB |
- Submission date
- 19/05/2022
- Registration date
- 20/05/2022
- Last edited
- 27/05/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Deferred
- Condition category
- Other
Plain English summary of protocol
Not provided at time of registration
Contact information
Principal investigator
Parexel Early Phase Clinical Unit
Level 7, Northwick Park Hospital
Watford Road
Harrow
London
HA1 3UJ
United Kingdom
| Phone | +44 (0)808 134 6555 |
|---|---|
| drugtrial@parexel.com |
Scientific
Parexel Early Phase Clinical Unit
Level 7, Northwick Park Hospital
Watford Road
Harrow
London
HA1 3UJ
United Kingdom
| Phone | +44 (0)808 134 6555 |
|---|---|
| drugtrial@parexel.com |
Public
Parexel Early Phase Clinical Unit
Level 7, Northwick Park Hospital
Watford Road
Harrow
London
HA1 3UJ
United Kingdom
| Phone | +44 (0)808 134 6555 |
|---|---|
| drugtrial@parexel.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Pharmacokinetic pharmacodynamic safety and tolerability study |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | A phase 1 trial evaluating the pharmacokinetics, pharmacodynamics, safety, and tolerability of imlifidase after administration of a single intravenous dose in healthy Japanese men |
| Study objectives | PK/PD in healthy Japanese volunteers |
| Ethics approval(s) | 1. Approved 05/05/2022, London-Brent REC (80 London Road, Skipton House, London, SE1 6LH, UK; +44(0)20 7104 8137; brent.rec@hra.nhs.uk), ref: 22/LO/0315 2. Approved 05/05/2022, MHRA (10 South Colonnade, Canary Wharf, London, E14 4PU, UK; +44 (0) 20 3080 6000; info@mhra.gov.uk), ref: CTA 46323/0005/001-0001 |
| Health condition(s) or problem(s) studied | Healthy volunteers |
| Intervention | All subjects received an intravenous dose of 0.25 mg/kg imlifidase on Day 1, administered over 15 minutes. Follow up for 14 days. |
| Intervention type | Drug |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | Imlifidase |
| Primary outcome measure(s) |
PK was measured as concentration of imlifidase in serum from pre-dose until Day 14 |
| Key secondary outcome measure(s) |
1. Safety was assessed as adverse events (AEs) from obtaining the informed consent throughout the study. An AE is any untoward medical occurrence in a subject participating in the clinical trial. An AE could be any unfavourable and unintended sign, symptom or disease temporally associated with the treatment, whether or not considered related to the study drug |
| Completion date | 30/09/2022 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target sample size at registration | 8 |
| Key inclusion criteria | 1. Healthy man 2. Between 20 and 60 years old 3. Both parents and all 4 grandparents were ethnically Japanese |
| Key exclusion criteria | 1. Previous participation in this study 2. Present participation in another clinical trial, or use of any investigational drug or therapy, taking into account participation in a medical device study, within 90 days or 5 half-lives, whichever is longer, prior to administration of IMP 3. Prescence or history of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject’s ability to participate in the study |
| Date of first enrolment | 29/06/2022 |
| Date of final enrolment | 30/09/2022 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Watford Road
Harrow
London
HA1 3UJ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | The datasets generated and/or analysed during the current study are not expected to be made available because of their high commercial sensitivity and the negligible benefit to the public of publication of results of non-therapeutic clinical trials. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 23/05/2025 | 23/05/2025 | No | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- ISRCTN45338135_BasicResults_23May2025.pdf
- Basic results
Editorial Notes
The information for which publication was previously deferred has been added to the following fields:
1. The public title
2. The scientific title
3. Study hypothesis
4. Condition
5. Interventions
6. Drug name(s)
7. Primary outcome measure
8. Secondary outcome measures
9. Participant inclusion criteria
10. Participant exclusion criteria
23/05/2025: The basic results have been uploaded as an additional file.
20/05/2022: Trial's existence confirmed by MHRA.
