NL-OMON52682招募中不适用
A MULTICENTRE, SAD, AND MAD CLINICAL TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF IV TREATMENT OF CALY-002 IN HEALTHY SUBJECTS AND SUBJECTS WITH COELIAC DISEASE AND EOSINOPHILIC OESOPHAGITIS - CALY-CL19-001
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •For inclusion in Part B of the study, a subject with CeD should meet all of the
- •following criteria:
- •1. Subject is a male or female >= 18 years of age, at the time of signing the
- •2. Subject has a BMI between > 17.5 and < 35.0 kg/m2 (both inclusive).
- •3. Subject must be willing to consent to all study-related procedures and
- •visits, including a minimum of 2 endoscopy procedures with small intestine
- •biopsies during study participation. Subject must have signed an ICF indicating
- •that he/she understands the purpose of and procedures required for the study
- •and is willing to participate in the study.
- •4. Subject must have a diagnosis of CeD by intestinal biopsy at least 12 months
- •prior to screening as confirmed by medical records.
- •5. Subject must have no histological signs of active CeD at screening as
- •confirmed by a screening intestinal biopsy, with a VH:CD ratio > 1.5 and CD3+
- •IEL density < 40 cells/100 villus enterocytes.
- •6. Subject must have been on a GFD for at least 12 consecutive months prior to
- •screening and will have to remain on a GFD for the duration of study
- •participation (during the 8-week gluten challenge, subjects will consume
- •approximately 3 g of gluten daily while continuing with their GFD).
- •7. Subject must have negative anti-tissue transglutaminase (tTG) immunoglobulin
- •A (IgA) serology at screening. Note: At primary diagnosis of CeD, subjects
- •should have had a Marsh score of at least IIIA/B/C and either the existence of
- •positive TG-IgA serology that became negative upon GFD or clinical improvement
- •after introduction of GFD. If no TG-IgA serology was done at the first
- •diagnosis, then the investigator should contact the medical monitor and discuss
- •subject eligibility.
- •8. Subject must have human leukocyte antigen (HLA) genotype DQ2 or DQ8 as
- •confirmed by medical records.
- •9. Subject must be willing to undertake a gluten challenge (ie, intake of
- •approximately 3 g of gluten daily) for 56 consecutive days (8 weeks) during the
- •Treatment Period. Note: This will be the only allowed intake of gluten while
- •subjects need to remain on their GFD throughout study participation.
- •10. Subject must be healthy on the basis of physical examination findings,
- •clinical laboratory tests, medical history, vital signs, and cardiac monitoring
- •(normal 12-lead ECG results) performed at screening, in the opinion of the
- •investigator.
- •11. An FCBP must either commit to true abstinence from heterosexual contact or
- •agree to use, and be able to comply with, at least two effective contraceptive
- •methods (oral, injectable, or implantable hormonal contraceptive; tubal
- •ligation or intrauterine device; barrier contraceptive with spermicide; or
- •vasectomised partner), one of which must be a barrier method, from the time of
- •signing the ICF through EOS. In addition, an FCBP must have two negative
- •pregnancy tests as verified by the investigator prior to receiving the first
- •A negative serum FSH and β-HCG pregnancy test at screening.
- •A negative urine pregnancy test prior to randomisation on Day 1.
- •12. A male subject must practice true abstinence or agree to use a condom (a
- •latex condom is recommended) during sexual contact with a pregnant female or an
- •FCBP and will avoid conceiving from the time of signing the ICF through EOS,
- •even if he has undergone a successful vasectomy.<br
排除标准
- •A subject with CeD will not be eligible for inclusion in Part B of this study
- •if any of the following criteria apply:
- •1. Subject has a concurrent active autoimmune disease (other than CeD) that
- •requires systematic treatment with immunosuppressants. Note: Inclusion of
- •subjects with a history of autoimmune disease without symptoms or treatment for
- •more than 3 years or subjects with autoimmune thyroiditis that is well
- •controlled with levothyroxine substitutions can be discussed with the medical
- •2. Subject has severe complication of CeD such as refractory CeD.
- •3. Subject has active dermatitis herpetiformis.
- •4. Subject has active (microscopic) colitis with clinical signs of
- •diarrhoea and abdominal pain.
- •5. Subject has any significant medical condition (including but not limited to
- •neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological,
- •pulmonary, metabolic, endocrine, haematological, drug allergies, or other major
- •disorders), laboratory abnormality, or psychiatric illness that would prevent
- •the subject from participating in the study.
- •6. Subject has any condition that confounds the ability to interpret data from
- •7. Subject is pregnant or breastfeeding.
- •8. Subject is currently receiving or has been previously treated with a
- •biologic agent. Exception: If prior treatment with the biologic agent was
- •completed at least 6 months prior to the first dose, the medical monitor can be
- •consulted for potential recruitment.
- •9. Subject has a history of anaphylactic reactions to protein therapeutics.
- •10. Subject has evidence of SARS-CoV-2 infection and/or subject has not been
- •fully vaccinated for COVID-19 (according to the vaccine's local summary of
- •product characteristics) at least 2 weeks before screening and/or subject is
- •deemed at risk for the coronavirus disease (COVID19) in the opinion of the
- •treating physician or the subject has participated in another clinical study
- •involving treatment(s), which may increase such risk.
- •11. Subject has participated or is planning to participate in another
- •investigational drug study within 60 days prior to the first dose.
- •12. Subject has malignancy or prior malignancy, with a disease free interval of
- •< 5 years after diagnosis and intervention, except for curative treatment for
- •non-melanoma skin cancer or resected carcinoma in situ.
- •13. Subject has current or recent (within 4 weeks prior to screening) signs or
- •symptoms of infection that require parenteral antibiotic administration.
- •14. Subjects has a hepatitis B infection (confirmed by HBsAg), hepatitis C
- •infection (confirmed by HCV RNA testing), or HIV 1 or HIV-2 antibodies or
- •infection at screening.
- •15. Subject has had major surgery (including joint surgery) within 8 weeks
- •prior to screening and hospitalisation for a clinically relevant event within
- •the 4 weeks prior to screening.
- •16. Subject has received immunisation with a live or live attenuated vaccine
- •within 60 days prior to the first dose or is planning to receive immunisation
- •with a live or live attenuated vaccine within 60 days after the last dose.
- •17. Subject has been committed to an institution by way of official or judicial
- •18. Subject has used any new prescription or experimental drugs (including
- •biologics/monoclonal antibodies) for the treatment of their coeliac disease 30
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