allergic mediated diseases allergic asthma and food allergy chronic idiopathic and inducible urticaria chronic rhinosinusitis
Conditions
Interventions
THB001 micronized blend free base as capsules.
Micronized THB001 HCl salt as capsules.
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. Men and women, age 18-65 years inclusive at Screening will be enrolled. 4. 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 a letter from their GP. All women must have a negative pregnancy test result at Screening and on Day -1 before first administration of study medication. 5. It is important that male subjects not impregnate others while in the study. Therefore, male subjects who are biologically capable of having children must: - Remain sexually abstinent, when this is in line with his preferred and usual lifestyle. OR - Engage exclusively in same-sex relationships. OR - Agree to avoid impregnating his partner during the study (including washout periods) and for at least 90 days after the last dose of study medication. AND - Must use a combination of two methods of contraception during the study (including washout periods) and for at least 90 days after the last dose of study medication. One of the contraceptive methods must be a condom with spermicide (this is considered a single method). The second contraceptive method must include one of the following: diaphragm in combination with a spermicide; intrauterine device (IUD); contraception implant; progesterone-only pills (POPs); injectable progestogen (Depo-Provera®); combination hormonal contraceptive method (tablets, patches, or vaginal ring with both oestrogen and progestogen), OR have a partner who had her last natural menstruation >=24 months prior to the Screening Visit, OR have a partner who was surgically sterilized prior to the Screening Visit. AND - Not donate sperm during the study (including washout periods) and for at least 90 days after the last dose of study drug. OR - Male subjects who have had a vasectomy at least 4 months prior to the Screening Visit and must have completed post-surgical follow up to confirm
Exclusion criteria
Exclusion criteria: 1. A positive urine drug screen/alcohol breath test at Screening or Day -1 of the first treatment period. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK parameters including but not limited to: Cmax, tmax, t1/2, AUC0-t, and AUC0-inf, dose normalized Cmax. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability parameters including: physical examination, AEs, clinical laboratory values, vital signs and 12-lead ECGs. | — |
Countries
Netherlands
Outcome results
None listed