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| ID | Type | Description | Link |
|---|---|---|---|
| 2026-526153-34-00 | EU Trial (CTIS) Number |
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This is a phase 1, double-blind, randomized, placebo-controlled, single center, repeat-dose trial for the assessment of safety, tolerability, bioavailability and pharmacokinetic profiles of 150 mg CIT-013 in healthy adult volunteers
The active treatment in this trial is CIT-013, an investigational medicinal product that will be administered at a fixed dose level of 150 mg, subcutaneous (one 50 mg and one 100 mg injection), and is compared against placebo. CIT-013 is an IgG1k monoclonal antibody consisting of two identical light chain polypeptides composed of 219 amino acids each and two identical heavy chain polypeptides composed of 451 amino acids each. CIT-013 and placebo will be administered via subcutaneous injection in the abdominal wall.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CIT-013 high dose | Experimental | CIT-013 high dose |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CIT-013 high dose | Drug | CIT-013 |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability | Frequency and severity of treatment-emergent adverse events (TEAE) throughout the trial period, including clinically relevant findings, and antidrug antibody (ADA) results. | 6 weeks |
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Inclusion Criteria:
Healthy men or women, 18 to 75 years of age (inclusive) at screening.
Exclusion Criteria:
Evidence of any active or chronic disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the trial, or that would pose an unacceptable risk to the participant in the opinion of the Investigator.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Leonie M Middelink | Contact | +31613328444 | lmiddelink@citryll.com |
| Name | Affiliation | Role |
|---|---|---|
| Maarten Kraan | Citryll BV | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON | Groningen | Netherlands |
|
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | https://doi.org/10.1080/19420862.2023.2281763 |
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| Drug |
placebo |
|