allergic mediated diseases allergic asthma and food allergy chronic idiopathic and inducible urticaria chronic rhinosinusitis
Conditions
Interventions
THB001 Drug Product
Caffeine (CYP1A2 substrate)
Omeprazole (CYP2C19 substrate)
Midazolam (CYP3A4 substrate)
Sponsors
Third Harmonic Bio
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Subjects must understand the nature of the study and must provide signed and dated written informed consent in accordance with local regulations before the conduct of any study-related procedures. 2. Healthy as determined by the Investigator, based on a medical evaluation including medical history, physical examination, laboratory tests and ECG recording. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if, in the opinion of the Investigator, the finding is (a) unlikely to introduce additional risk to the subject, (b) will not interfere with study procedures or confound study results, and (c) is not otherwise exclusionary (see Exclusion Criteria). 3. Vasectomized men and women, age 18-65 years inclusive at will be enrolled. Women of child-bearing potential must agree not to attempt to become pregnant and to use a highly effective form of hormonal (excluding oral contraceptives) or non-hormonal birth control, which entails the use of a non-hormonal intra-uterine device/system in combination with a barrier method (e.g. condom, diaphragm, cervical cap with spermicide) or abstinence during the study and for 90 days after the (last) study drug administration. Postmenopausal women must have had >=12 months of spontaneous amenorrhea (with documented follicle-stimulating hormone (FSH) >=30 mIU/mL). Surgically sterile women are defined as those who have had a hysterectomy, bilateral ovariectomy, or bilateral tubal ligation. Women who are surgically sterile must provide documentation of the procedure by an operative report or by ultrasound. All women must have a negative pregnancy test result on Day 1 before (first) administration of study medication. Male subjects must have had a vasectomy at least 4 months prior to the Screening Visit and must have a documented post-surgical follow up to confirm success of the vasectomy. They must also agree to use a condom from Day 1 until 90 days after the last dose of study.
Exclusion criteria
Exclusion criteria: 1. A positive urine drug screen/alcohol breath test at Screening or Day -1. 2. A positive Hepatitis B surface antigen or positive Hepatitis C antibody result at screening. 3. A positive test for human immunodeficiency virus (HIV) antibody at screening. 4. Alanine aminotransferase, aspartate aminotransferase, or total bilirubin levels greater than the upper limit of normal (ULN) at Screening or Day -1. One test result up to 1.25 x the ULN is allowed. One retest at Screening and on Day -1 is allowed. Subjects with Gilbert*s Syndrome are permitted to have total bilirubin values outside the 1.25 x the ULN, as judged by the Investigator as long as the AST and ALT are within normal limits (WNL). 5. Hemoglobin, Platelet count, or White blood cell count below the lower limit of normal LLN at Screening. Hemoglobin, Platelet count, or White blood cell count below the LLN on Day -1. One retest is allowed at each visit. 6. Serum creatinine greater than the ULN at Screening or Day -1. One retest is allowed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK parameters for midazolam, caffeine and omeprazole include, but are not limited to: Cmax, tmax, AUC0-t, and AUC0-inf. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability parameters include: physical examination, AEes, clinical laboratory values, vital signs and 12-lead ECGs. | — |
Countries
Netherlands
Outcome results
None listed