A Safety and Tolerability Study of FCN-207 in Healthy Volunteers

Hyperuricemia Clinical Trial

Official title:

A Phase 1, Single-center, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study to Access the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food-effect of FCN-207 in Healthy Volunteers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04622124
• Other study ID #: FCN-207-Ph?-001
• Status: Recruiting
• Phase: Phase 1
• Start date: November 11, 2020
• Est. completion date: June 7, 2022

Study information

• Verified date: November 2021
• Source: Fochon Pharmaceuticals, Ltd.
• Contact: Yang Huan
• Phone: +86 15882196553
• Email: hyang[@]fochon.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This research study is studying an investigational drug called FCN-207 in healthy adult males or females.

Description:

This is a Phase 1, single-center, dose-escalations (SAD and MAD) and food effect study of FCN-207:

Part 1 Single Ascending Dose (SAD) study: randomized, double-blind, placebo-controlled.

Part 2 Food-effect study: single-dose, two-treatment (fasted vs. high-fat meal), two-sequence crossover design.

Part 3 Multiple Ascending Dose (MAD) study: randomized, double-blind, placebo-controlled.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 116
• Est. completion date: June 7, 2022
• Est. primary completion date: December 21, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Male or female healthy subjects who were aged at 18 - 45 years;

2. Weight = 50 kg,Body Mass Index(BMI)= Weight(kg)/(Height)2(m2), BMI at 19 - 28 kg/m2(Including boundary value);

3. No birth plan during the trial period and within 6 months after completion and are willing to use non-hormonal contraceptive measures;

4. To understand the research procedure and method, voluntarily participate in the experiment and signed the informed consent;

Exclusion Criteria:

1. Blood uric acid < 4 mg/dL(240 µmol/L)or >7 mg/dL(420 µmol/L);

2. After inquiry and physical examination,subjects who have had cardiovascular, liver, kidney, gastrointestinal respiratory, neurological, mental, immune, blood, endocrine and metabolic diseases, or clinically significant symptoms/signs, or self-report the history of diseases;

3. Physical examination(Height, weight, breathing, pulse, blood pressure, chest and abdominal examinations, etc)or the laboratory indexes [ Blood routine, urine routine, blood biochemistry ( including myocardial enzyme spectrum ), blood amylase and urine amylase, blood coagulation test, infectious disease screening, etc] were abnormal and have clinical significance;12-lead ECG?B-ultrasonography and chest radiograph is abnormal and have clinical significance.

4. Subjects who have had a history of smoking (more than 5 cigarettes per day) and drinking alcohol (more than 15g of alcohol per day for women and more than 25g for men (15g is equivalent to 450ml of beer, 150ml of wine or 50ml of low-alcohol liquor), more than twice a week), and had a history of drug abuse;

5. According to the investigator's judgment, the subject may be allergic to the test drug or any of its ingredients;

6. Subjects with a history of hyperuricemia and/or gout disease, or have received drugs that affect uric acid synthesis, metabolism and excretions within 1month before the screening; A history of kidney stones or B-mode ultrasonography during screening showed kidney stones;

7. Alanine aminotransferase and/or aspartate aminotransferase >1.5 times normal upper limit, and/or total bilirubin>1.5 times normal upper limit;

8. eCRCL = 90mL/min ,Calculation formula:Male(140-AGE)×BW(KG)/(72×SCR),Female(140-AGE)×BW(KG)/(72×SCR)×0.85,SCR unit:µmol/L /dl;

9. Subjects who have had any surgery within 6 months before screening;

10. Subjects who have had participated in blood donation volume is = 400 ml or have received blood transfusion within 3 months before the screening;

11. Subjects who have had participated in a clinical trial of any drug or medical device within 3 months before the screening;

12. Subject who have had any prescription drugs (proton pump inhibitors and antacids, etc.)?counter drugs?Chinese herbal medicines or food supplements that may affect the drug under the test within 1 months before the random;

13. Subjects who have had any acute illness experience of clinical significance as determined by the investigator within 1 months before the screening;

14. Subjects who have had smoked, drank alcohol, drank xanthine or caffeine-containing food and beverages, exercised vigorously, or had other factors affecting drug absorption, distribution, metabolism, and excretion within 2 days before the random;

15. Hepatitis B surface antigen, hepatitis C antibody, HIV antibody, and syphilis antibody is checked positive person;

16. Females during pregnancy or breastfeeding;

17. Subjects who are not suitable for venous blood sampling collection;

18. The investigator judges that the subject has a disease that affects drug absorption, distribution, metabolism and excretion or can reduce compliance(Cardiovascular, liver, kidney, digestive tract, immune, blood, endocrine, metabolic, cancer, psychoneurosis, etc);subjects may be in a situation or with a condition that, in the opinion of the investigator, would interfere with optimal participation in the study;

19. Subjects who have had a risk factor for TVT or a family history (i.e., parent, sibling, or child) of short QT syndrome, long QT syndrome, unexplained sudden death, drowning, or infant syndrome in their youth (Less than/equal to age 40);

20. Subjects who have had blood potassium, blood magnesium or blood calcium exceeds the normal range;

Related Conditions & MeSH terms

• Hyperuricemia

Intervention

Drug:
• Placebo

Dietary Supplement:
• fasted vs. high-fat meal

Drug:
• Placebo

Locations

Country	Name	City	State
China	Peking university Third Hospital	BeiJing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Fochon Pharmaceuticals, Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pharmacokinetics(CFE:Cumulative fecal excretion)		At week1, 2, 3
Primary	To quantify the occurrence of adverse events (AEs) reported in all subjects who received study drug	Incidence of untoward medical occurrences (adverse event = AE) in a participant who received study drug. Adverse events will be evaluated by dosing cohort and recorded according to NCI CTCAEv5 Common Toxicity Criteria	Up to week 4
Primary	To determine the occurrence of treatment-emergent adverse events (TEAs)	Incidence of untoward medical occurrences (adverse event = AE) attributed to study drug in a participant who received study drug. Adverse events will be evaluated and recorded by dosing cohort according to NCI CTCAEv5 Common Toxicity Criteria	Up to week 4
Primary	To determine the occurrence of treatment-related adverse events meeting the criteria for dose limiting toxicities (DLTs)	Incidence of the DLT population will consist all subjects who received the required amount of study drug during the DLT observation period (single ascending doses group:7 days ,multiple ascending doses:21 days) of study treatment . Treatment related AE is any untoward medical occurrence attributed to study drug in a participant that who received study drug. DLTs are adverse events meeting the protocol-specified criteria, evaluated and recorded according to NCI CTCAEv5 Common Toxicity Criteria will use medical terminology based on the Medical Dictionary for Regulatory Activities Terminology (MedDRA).	Up to week 4
Secondary	Pharmacokinetics (AUC: Area under the plasma concentration-time curve)		2 weeks
Secondary	Pharmacokinetics (Cmax: Maximum plasma concentration)		2 weeks
Secondary	Pharmacokinetics (Tmax: Time to reach the peak plasma concentration)		2 weeks
Secondary	Pharmacokinetics (T1/2: Elimination half-life of plasma concentration)		2 weeks
Secondary	Pharmacokinetics (CL/F)		2 weeks
Secondary	Pharmacokinetics (Vd/F: Distribution volume / Fraction of dose absorbed)		2 weeks
Secondary	Pharmacokinetics (?z:Elimination rate constant)		2 weeks
Secondary	Pharmacokinetics (DF)		2 weeks
Secondary	Pharmacokinetics (RCmax: Cmax accumulation multiple consecutive times)		2 weeks
Secondary	Pharmacokinetics (RAUC:AUC accumulation multiple consecutive times)		2 weeks