None listed
Conditions
Brief summary
The purpose of this study is to establish the safety and tolerability of orally administered FP-045 in healthy subjects following multiple-dose escalation. This Phase 1 study will support dose selection for future studies in patients with Peripheral arterial disease.
Interventions
Approximately 3 cohorts of Normal Healthy Volunteers (NHV) will be enrolled with sentinel dosing in each cohort. Subjects in each cohort will be randomized to orally receive either FP-045 (6 subjects) or placebo (2 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.
Cohort 1 will receive 120 mg daily oral dose of FP-04
Approximately 3 cohorts of Normal Healthy Volunteers (NHV) will be enrolled with sentinel dosing in each cohort. Subjects in each cohort will be randomized to orally receive either FP-045 (6 subjects) or placebo (2 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. Cohort 1 will receive 120 mg daily oral dose of FP-045 or Placebo for 7 days. Cohort 2 will receive 250 mg daily oral dose of FP-045 or Placebo for 7 days. Cohort 3 will receive 500 mg daily oral dose of FP-045 or Placebo for 7 days. All subjects will remain in the Clinical Research Unit (CRU) for observation until completion of all assessments on Day 10. 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
Other
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
1. Male or female NHV, age 18 to 55 years, inclusive (at the time of informed consent). 2. Females must be either postmenopausal for greater than or equal to 1 year (or with FSH greater than or equal to 40 mIU/mL if postmenopausal for less than 1 year) or surgically sterile (having undergone bilateral tubal ligation, hysterectomy, or bilateral oophorectomy) for at least 6 months. 3. Males with female partners of childbearing potential must agree to use 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. 4. The subject is, in the opinion of the Investigator, generally healthy based on assessment of medical history, physical examination, vital signs, electrocardiogram (ECG), and the results of the hematology, clinical chemistry, urinalysis, serology, and other laboratory tests. 5. Baseline laboratory test values within reference ranges based on the blood and urine samples taken at Screening and on Day -1 (before administration of the initial study drug). Out of normal ranges values may be accepted by the Investigator, if not clinically significant. 6. Nonsmoker and/or ex-smoker who has discontinued smoking and/or use of nicotine containing products for at least 6 months prior to the first dose of study drug 7. Body mass index between 18 and 30 kg/m2, inclusive. 8. Written informed consent obtained. 9. Ability to communicate well with the Investigator, in the local language, and to understand and comply with the requirements of the study.
Exclusion criteria
1. History or presence of any clinically significant neurological, metabolic, gastrointestinal, endocrinological (in particular diabetes or pre-diabetes), cardiovascular, hematological, hepatic, immunological, renal, respiratory, chronic infections, psychiatric, or genitourinary abnormalities or diseases. Note: NHVs with a history of uncomplicated kidney stones or asthma may be enrolled in the study at the discretion of the Investigator. 2. History of malignant neoplastic disease, with the following exceptions: a. Adequately treated non-melanomatous skin carcinoma b. Female with a history of benign cervical carcinoma neoplasia if compliant with surveillance and treatment as recommended by her physician 3. Mentally or legally incapacitated, has significant emotional problems at Screening or expected during the conduct of the study, or has a history of a clinically significant psychiatric disorder within the last 5 years. Note: NHVs who have had situational depression may be enrolled in the study at the discretion of the Investigator. 4. The subject has a history of severe drug allergy or hypersensitivity or food allergy, including anaphylaxis. 5. The subject has had surgery or trauma with significant blood loss within the last 3 months prior to the first dose of study drug. 6. The subject has donated more than 1 unit (500 mL) of blood with 4 weeks prior to the first dose of study drug. 7. Fever (body temperature greater than 38°C) or symptomatic viral or bacterial infection within 2 weeks prior to Screening. 8. Blood pressure greater than 140/90 mm Hg or heart rate greater than 100 beats per minute at Screening or at Day 1. Vitals may be repeated up to 2 times for the purpose of eligibility. 9. Clinically significant laboratory abnormalities including: a. Impaired renal function (serum creatinine levels greater than 1.2 mg/dL) at Screening; estimated creatinine clearance (CrCl) of less than 80 mL/minute b. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) laboratory values greater than 1.2 × upper normal limits 10. Clinically significant abnormality on ECG performed at Screening or prior to administration of the first dose of study drug. (Screening ECG conduction intervals must be within gender specific normal ranges [QT interval corrected for heart rate [QTc] males less than or equal to 450 msec and females less than or equal to 470 msec].) 11. Positive test for hepatitis C antibody, hepatitis B surface antigen, or human immunodeficiency virus antibody at Screening 12. Positive screen for drugs with a high potential for abuse (amphetamine, cannabinoid, cocaine, morphine, and phencyclidine) at Screening and Study Day -1. 13. Consumed food or drink containing grapefruit juice within 72 hours before start of dosing or expected to do so through Study Day 14 End of Study/Early Termination. 14. Consumed alcohol within 72 hours before start of dosing through Study Day 14 End of Study/Early Termination. 15. Received any previous FP-045 or has taken any investigational product within 30 days or 5 half-lives (whichever is longer) prior to the first dose of study drug. 16. Female who is breastfeeding or has a positive pregnancy test 17. Unwilling or unable to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject’s return for the scheduled EOS Visit 18. The subject has taken prescription medications within 2 weeks (or within 5 half-lives, whichever is longer) or nonprescription medication, herbal remedies, vitamins or minerals within 1 week prior to the administration of the first dose of study and continuing throughout the study until the final study visit. Note: There may be certain medications that are permitted at the discretion of the Investigator and Sponsor (including paracetamol/ acetaminophen, which may be used for minor ailments during the course of the study without prior consultation with the Sponsor’s Medical Monitor). 19. 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