allergic mediated diseases allergic asthma and food allergy chronic idiopathic and inducible urticaria chronic rhinosinusitis
Conditions
Interventions
None listed
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. In Part 1 and 2, men and women aged 18-65 years (inclusive) at the time of Screening will be enrolled, and in Part 3 vasectomized men and women aged 18-65 years (inclusive) at the time of 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 an operative report or by ultrasound. All women must have a negative pregnancy test result on Day -1 before (first) administration of study medication.
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. 4. Alanine aminotransferase, aspartate aminotransferase, or total bilirubin levels greater than the upper limit of normal (ULN) at Screening or Day -1 of the (first) treatment period. One test result up to 1.25 x the ULN is allowed. One retest at Screening and on Day -1 of the (first) treatment period 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1, Part 2 and Part 3 • Safety and tolerability parameters include: physical examination, AEs, clinical laboratory values, vital signs and ECGs (3-lead telemetry and 12-lead ECGs). | — |
Secondary
| Measure | Time frame |
|---|---|
| Part 1 and Part 2 • PK parameters for THB001 include: Cmax, tmax, t1/2, AUC0-t, AUC0-inf, CL/F and Vz/F. Part 1 and Part 3 Mean hourly heart rate analysis including change from baseline and placebo corrected change from baseline (if applicable) for each subject, heart rate nadir and time to heart rate nadir. Optional analysis of cardiodynamic parameters including precision QT analysis may be performed. Part 3 • PK parameters for THB001 include: Cmax, tmax, t1/2, AUC0-t, AUC0-tau, AUC0-inf, CL/F (Day 1 only), Vz/F (Day 1 only), Cmin, Cmin,ss, CLss/F, Vss/F, Cssavg, and AR. | — |
Countries
Netherlands
Outcome results
None listed