Phase 1 Trial to Evaluate 150 mg Subcutaneous CIT-013

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Repeat-Dose Trial to Evaluate 150 mg Subcutaneous CIT-013 Administration in Healthy Adult Volunteers

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07499908

Acronym

Citysky

Enrollment

Registered

2026-03-30

Start date

2026-05-31

Completion date

2026-10-31

Last updated

2026-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Adult

Brief summary

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

DRUGCIT-013 high dose

CIT-013

DRUGPlacebo

placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Safety and tolerability	6 weeks	Frequency and severity of treatment-emergent adverse events (TEAE) throughout the trial period, including clinically relevant findings, and antidrug antibody (ADA) results.

Countries

Netherlands

Contacts

CONTACTLeonie M Middelink

lmiddelink@citryll.com+31613328444

STUDY_DIRECTORMaarten Kraan

Citryll BV

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 14, 2026