None listed
Conditions
Brief summary
The purpose of this study is to evaluate the safety and tolerability of 28 days of daily dosing of orally administered FP-045 400 mg into normal, healthy volunteers
Interventions
Approximately 10 Normal Healthy Volunteers (NHV) will be enrolled in the study. Subjects will be randomized to orally receive either FP-045 (7 subjects) or placebo (3 subjects) at doses and intervals as presented below:
Active treatment will be FP-045 (powder for oral solution) for reconstitution in cranberry juice and delivered as 120 mL oral solution total dosing volume per subject's cohort.
Study participants will receive 400 mg daily oral dose of FP-045 or Placebo for 28 days.
All subject
Approximately 10 Normal Healthy Volunteers (NHV) will be enrolled in the study. Subjects will be randomized to orally receive either FP-045 (7 subjects) or placebo (3 subjects) at doses and intervals as presented below: Active treatment will be FP-045 (powder for oral solution) for reconstitution in cranberry juice and delivered as 120 mL oral solution total dosing volume per subject's cohort. Study participants will receive 400 mg daily oral dose of FP-045 or Placebo for 28 days. All subjects will remain in the Clinical Research Unit (CRU) for observation until completion of all assessments on Day 31. Dosing will take place in the morning on dosing days under the supervision of study staff. Study drug compliance will be documented in the eCRF by recording: The date and time of each oral administration, The volume of each oral dose administered, Whether or not the entire amount of each oral dose of FP-045 was administered and whether or not subject vomited after administration of the dose.
Sponsors
Foresee Pharmaceuticals Co., Ltd.
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
• Male or female, age 18 to 55 years • Females must be either postmenopausal for equal to 1 year (or with follicle-stimulating hormone (FSH) equals to 40 mIU/mL if postmenopausal for less than 1 year) or surgically sterile • Males with female partners of childbearing potential must agree to use a barrier contraceptive (i.e., condom) and their female partners must use a highly effective method of contraception from Screening through 90 days after the last dose of study drug. Males must also refrain from sperm donations during this time period. Males who are abstinent will not be required to use a contraceptive method unless they become sexually active. • Nonsmoker, ex-smoker, or light smoker who smokes less than 5 cigarettes per week and has a negative urine cotinine test at screening. • Body mass index between 18 and 32 kg/m2, inclusive.
Exclusion criteria
• The subject has had surgery or trauma with significant blood loss within the last 3 months prior to the first dose of study drug. • The subject has donated more than 1 unit (500 mL) of blood with 4 weeks prior to the first dose of study drug. • Fever (body temperature >38°C) or symptomatic viral or bacterial infection within 2 weeks prior to Screening • Clinically significant laboratory abnormalities including: • Positive test for hepatitis C antibody, hepatitis B surface antigen, or human immunodeficiency virus antibody at Screening • Positive screen for drugs with a high potential for abuse • Consumed food or drink containing grapefruit juice within 72 hours before start of dosing unless approved by the investigator and sponsor. • Consumed alcohol within 72 hours before start of dosing. • The subject has taken prescription medications within 14 days (or within 5 half-lives, whichever is longer) or nonprescription medication, herbal remedies, vitamins or minerals within 7 days prior to the administration of the first dose of study, unless otherwise approved by the investigator and sponsor. • The subject exercises extensively (e.g. marathon, triathlon or other similar high energetic sports). In general, subjects should refrain from sporting from 4 days before participation in the study until the EOS/ET visit.
Outcome results
None listed