A Two-Part, Open-Label, Single-Dose Relative Bioavailability and Food Effect Study of THB001 in Healthy Adults
- Conditions
- allergic mediated diseasesallergic asthmaand food allergychronic idiopathic and inducible urticariachronic rhinosinusitis
- Registration Number
- NL-OMON50446
- Lead Sponsor
- Third Harmonic Bio
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method