Phase 1 study for people with Crohn's Disease and Colitis

Reproduced exactly, unedited. Written for researchers rather than for patients.

Inclusion Criteria:

1. Healthy male or female, aged between 18 and 65 years, inclusive at Screening.
2. Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive.
3. Carry the HLA DRB4*0101 or DRB4*0103 allele.
4. Participant is medically healthy (in the opinion of the Investigator), as determined by pre-study medical history and without clinically significant (CS) abnormalities.
5. Female participants must be of non-child-bearing potential, or, if of child-bearing potential, must have negative pregnancy test, agree not to become pregnant or donate ova, and must agree to use adequate contraception.
6. Male participants must agree not to donate sperm and use adequate contraception.

Exclusion Criteria:

1. Any active infection that requires systemically absorbed antibiotic, antifungal, antiparasitic or antiviral medications.
2. History of hypersensitivity reaction, anaphylaxis or other CS reactions or known allergy to the study drug or its ingredients including but not limited to dextran.
3. History of any CS disorder which, in the opinion of the Investigator would make implementation of the protocol or interpretation of study results difficult, or that would put the participant at risk by participating in the study.
4. History of surgery or hospitalisation within 4 weeks prior to Screening, or surgery planned during the study.
5. Participant has donated blood or blood products or experienced significant blood loss within 2 months prior to the first dose of study drug.
6. Use of any vaccinations within 4 weeks prior to the first dose of study drug.
7. Laboratory results at Screening that indicate inadequate renal function, with estimated creatinine clearance of < 60 mL/min/1.73m2.
8. Use of any prescription medication within 14 days prior to the first dose of study drug and/or over-the-counter medication/vitamins/supplements/herbal/ plant-derived medications within 7 days prior to the first dose of study drug.
9. Concurrent enrolment in another clinical study, or participation in another clinical study within 30 days or 5 half-lives, whichever is longer, prior to Screening.
10. Regular consumption of > 10 standard alcoholic drinks/week. Participant is unwilling to abstain from alcohol while confined to the study clinic.
11. Positive alcohol breath test at Screening, upon admission to the clinic on Day -1.
12. Positive urine drugs of abuse test at Screening, upon admission to the clinic on Day -1.
13. Participant is a heavy smoker, define as more than 2 cigarettes per day or 10 per week.
14. Participant is unwilling to abstain from smoking while confined to the study clinic.
15. Participant is breastfeeding/lactating or pregnant, or planning to breastfeed or become pregnant during the study.
16. Positive Hepatitis B surface antigen (HBsAg), Hepatitis C (HepC) virus antibody, or human immunodeficiency (HIV) antibody tests.
17. Positive for tuberculosis (TB) disease or latent TB infection.
18. Ingestion of poppy seed-containing foods or beverages within 48 hours prior to first dose of study drug.