NCT07499908

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
5mo left

Started May 2026

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 30, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

May 31, 2026

Expected
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2026

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2026

Last Updated

April 13, 2026

Status Verified

March 1, 2026

Enrollment Period

3 months

First QC Date

March 24, 2026

Last Update Submit

April 8, 2026

Conditions

Healthy Adult

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

CIT-013 high dose

EXPERIMENTAL

CIT-013 high dose

Drug: CIT-013 high dose

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

CIT-013 high doseDRUG

CIT-013

CIT-013 high dose
PlaceboDRUG

placebo

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy men or women, 18 to 75 years of age (inclusive) at screening.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ICON

Groningen, Netherlands

Location

Related Publications (1)

  • https://doi.org/10.1080/19420862.2023.2281763

    RESULT

Study Officials

  • Maarten Kraan

    Citryll BV

    STUDY DIRECTOR

Central Study Contacts

Leonie M Middelink

CONTACT

+31613328444lmiddelink@citryll.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2026

First Posted

March 30, 2026

Study Start (Estimated)

May 31, 2026

Primary Completion (Estimated)

August 15, 2026

Study Completion (Estimated)

October 31, 2026

Last Updated

April 13, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)