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NCT Number: NCT07499908

Phase 1 Trial to Evaluate 150 mg Subcutaneous CIT-013

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

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ICON

Groningen, Netherlands

Location contact

PI ICON PI ICON

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CIT-013 high dose

Drug

CIT-013

Placebo

Drug

placebo

Primary outcomes

  1. Safety and tolerability

    Time frame: 6 weeks

    Frequency and severity of treatment-emergent adverse events (TEAE) throughout the trial period, including clinically relevant findings, and antidrug antibody (ADA) results.

Study contacts

Contact information is provided by the study sponsor or research team.

Leonie M Middelink

CONTACT

[email protected]

+31613328444

Sponsors and collaborators

Lead sponsor

Citryll BV

Industry

Registry information

Official study title

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

Acronym: Citysky

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 30, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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