NCT07499908

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Citryll BV · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Adult

Interventions

Type	Name	Description
DRUG	CIT-013 high dose	CIT-013
DRUG	Placebo	placebo

Timeline

• Start date: 2026-05-31
• Primary completion: 2026-08-15
• Completion: 2026-10-31
• First posted: 2026-03-30
• Last updated: 2026-04-13

Locations

1 site across 1 country: Netherlands