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Clinical Trials/NL-OMON56333
NL-OMON56333
Recruiting
Not Applicable

A first-in-human, randomized, double-blind, placebo-controlled study to evaluate, single ascending doses of CIT-013 in healthy volunteers with and without an intravenous lipopolysaccharide challenge and repeat dosing in healthy volunteers and patients with Rheumatoid Arthritis. - CIT013 First in Human study

Citryll0 sites84 target enrollmentTBD
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Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Citryll
Enrollment
84
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
Citryll

Eligibility Criteria

Inclusion Criteria

  • •lnclusion criteria part A\- C, and HVs part D
  • •Eligible subjects must meet all the following criteria at screening:
  • •1\. Healthy men or women, 18 to 55 years of age (inclusive) at screening. For
  • •part B cohort 2 only healthy men will
  • •be included. The health status is verified by absence of evidence of any
  • •clinically significant activa or uncontrolled
  • •chronic disease following a detailed medical history, a complete physical
  • •examination including vital signs,
  • •laboratory measurements, and 12\-lead ECG;
  • •2\. Signed infonmed consent, able and willing to comply wilh the requirements of

Exclusion Criteria

  • •Exclusion criteria part A\- C, and HVs in part D
  • •Eligible subjects must not meet any of the following criteria at screening or
  • •1\. Evidence (following a detailed medical history, physical examination, vital
  • •signs, 12\-lead ECG and clinical
  • •laboratory parameters) of any active or chronic disease or condition that could
  • •interfere with, or for which the
  • •treatment might interfere with, the conduct of the study, or that would pose an
  • •unacceptable risk to the subject in
  • •the opinion of the investigator.
  • •2\. Clinically significant abnormalities, as judged by the investigator, in

Outcomes

Primary Outcomes

Not specified

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