CIT013 First in Human study

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 52

Inclusion Criteria

1. Healthy men or women of non-child bearing potential (WNCBP), 18 to 55 years of age (inclusive) at screening. The health status is verified by absence of evidence of any clinically significant active or uncontrolled chronic disease following a detailed medical history, a complete physical examination including vital signs, laboratory measurements, and 12-lead ECG;
2. Signed informed consent, able and willing to comply with the requirements of the study protocol.
3. Body mass index (BMI) between 18 and 32 kg/m2, inclusive, and a body weight between 50 and 150 kg, inclusive at screening.
4. All male volunteers must practice effective contraception during the study and be willing and able to continue contraception for at least 90 days after their last dose of study treatment.
5. Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the study restrictions.

Exclusion Criteria

1.Any confirmed or suspected disease or condition associated with immune system impairment, including autoimmune diseases, HIV, asplenia or recurrent severe infections.
2.Use of chronic (more than 14 days) immunosuppressant or immunomodulatory drugs within the 3 months prior to IMP administration, or isolated (non-chronic) use within 30 days prior to IMP administration.
3.Subject has an active, uncontrolled acute or chronic systemic fungal, bacterial, and/or viral, infection within the past 30 days.
4.Subjects with evidence or history of clinically significant haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases.
5.Subject has a positive SARS-CoV-2 PCR based test within 72 hours of receiving CIT-013.
6.Use of prescription or over-the-counter (OTC) drugs, vitamins, minerals and dietary supplements, within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication until EOS. Herbal supplements
7.and hormone replacement therapy must be discontinued 30 days prior to the first dose of study medication until EOS. Excluded from this list is paracetamol at doses of <4 g/day on all study days except day 1 of part B.
8.Exceptions will only be made if the rationale is clearly documented by the investigator.
9.Receipt of live or attenuated vaccine 90 days prior to first study intervention administration.
10.Vaccination (completion of 2nd vaccination shot if applicable) against SARS-CoV-2 or influenza vaccinations less than 14 days prior to first study drug administration.
11.Known hypersensitivity to any of the constituents or excipients of CIT-013 or history of relevant drug and/or food allergy (anaphylactic, anaphylactoid reactions).
12.Smoking > than 10 cigarettes (or equivalent) per week and/or using nicotine-based products within 1 month prior to CIT-013 administration and/or unwillingness to abstain from the use of these from screening until EOS.
13.Extreme exercise (e.g. marathon or triathlon) within 2 weeks of screening.
14.Subject has participated in an intravenous LPS challenge study before (Part B).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
• Treatment-emergent (serious) adverse events ((S)AEs) throughout the study at every study visit

Secondary Outcome Measures

Name	Time	Method
• Concomitant medication throughout the study at every study visit<br>• Vital signs (Pulse Rate (bpm), Systolic blood pressure (mmHg), Diastolic blood pressure (mmHg)) as per assessment schedule<br>• Clinical laboratory tests (Haematology, blood chemistry and urinalysis) as per assessment schedule<br>• ECG parameters (Heart Rate (HR) (bpm), PR, QRS, QT, QTcB, QTcF) as per assessment schedule<br>• PK parameters of CIT-013 by non-compartmental analysis of the serum concentration-time data: Single ascending dose:<br>• AUCinf, AUClast, CL, Cmax, t1/2, tlag, tmax, Vz<br>• Dose-normalized PK parameters: AUCinf, AUClast, Cmax<br>