Phase 1 Trial to Evaluate 150 mg Subcutaneous CIT-013
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CIT-013 high dose, Placebo.
- Who it may be relevant to
- Registry conditions: Healthy Adult. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Repeat-Dose Trial to Evaluate 150 mg Subcutaneous CIT-013 Administration in Healthy Adult Volunteers
Overview
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
Detailed description
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.
Interventions
- Drug CIT-013 high dose
CIT-013 - Drug Placebo
placebo
Primary outcome measures
- Safety and tolerability [Time frame: 6 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Netherlands · 1 center
- ICON — Groningen
Publications
- https://doi.org/10.1080/19420862.2023.2281763
Identifiers
NCT: NCT07499908 · CITRYLL006 · 2026-526153-34-00