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

NCT04622124 | Completed Phase 1

• 1 other identifier: FCN-207-PhⅠ-001
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hyperuricemia

Keywords

hyperuricemia; single and multiple ascending doses; food effect

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (10)

• Pharmacokinetics (AUC: Area under the plasma concentration-time curve)

  2 weeks

• Pharmacokinetics (Cmax: Maximum plasma concentration)

  2 weeks

• Pharmacokinetics (Tmax: Time to reach the peak plasma concentration)

  2 weeks

• Pharmacokinetics (T1/2: Elimination half-life of plasma concentration)

  2 weeks

• Pharmacokinetics (CL/F)

  2 weeks

Other Outcomes (1)

• Pharmacokinetics（CFE：Cumulative fecal excretion）

  At week1, 2, 3

Study Arms (3)

Part 1 Single Ascending Dose (SAD) study

PLACEBO COMPARATOR

The single ascending dose trial set up 7 dose groups of 2.5, 5, 10, 20, 40, 60 and 80 mg. The 2.5 mg dose group was the exploratory part with open label, while the other dose groups were double-blind. 8 subjects were randomly enrolled in each dose group, 6 of whom received FCN-207 tablets and 2 of whom received placebo. This part of the study evaluated the safety, tolerability, and pharmacokinetic and pharmacodynamic studies of single dose FCN-207 tablets in healthy volunteers.

Drug: Placebo

Part 2 Food-effect study

EXPERIMENTAL

Twelve subjects were enrolled and randomly divided into two groups. The subjects were given FCN-207 tablets after fasting and high-fat diet with double Cross experiment , and feces samples were collected for metabolism/excretion characteristics study.

Dietary Supplement: fasted vs. high-fat meal

Part 3 Multiple Ascending Dose (MAD) study

PLACEBO COMPARATOR

A total of 16 subjects were randomly assigned to each dose group for multiple dose study , including 12 who received FCN-207 tablets and 4 who received placebo for a 10-day administration cycle. The dosage of multiple administration was based on the results of single ascending dose study results , and the method of drug administration refers to the results of the food influence test.

Drug: Placebo

Interventions

Placebo DRUG

Part 1 Single Ascending Dose (SAD) study

fasted vs. high-fat meal DIETARY_SUPPLEMENT

Part 2 Food-effect study

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female healthy subjects who were aged at 18 - 45 years；
• Weight ≥ 50 kg，Body Mass Index（BMI）＝ Weight（kg）/（Height）2（m2）， BMI at 19 - 28 kg/m2（Including boundary value）；
• No birth plan during the trial period and within 6 months after completion and are willing to use non-hormonal contraceptive measures;
• To understand the research procedure and method, voluntarily participate in the experiment and signed the informed consent；

You may not qualify if:

• Blood uric acid \< 4 mg/dL（240 μmol/L）or \>7 mg/dL（420 μmol/L）；
• 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；
• 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.
• 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;
• According to the investigator's judgment, the subject may be allergic to the test drug or any of its ingredients；
• 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;
• Alanine aminotransferase and/or aspartate aminotransferase \>1.5 times normal upper limit, and/or total bilirubin\>1.5 times normal upper limit；
• 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；
• Subjects who have had any surgery within 6 months before screening;
• Subjects who have had participated in blood donation volume is ≥ 400 ml or have received blood transfusion within 3 months before the screening；
• Subjects who have had participated in a clinical trial of any drug or medical device within 3 months before the screening；
• 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;
• Subjects who have had any acute illness experience of clinical significance as determined by the investigator within 1 months before the screening;
• 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；
• Hepatitis B surface antigen, hepatitis C antibody, HIV antibody, and syphilis antibody is checked positive person;

Sponsors & Collaborators

• Fochon Pharmaceuticals, Ltd.: lead

Study Sites (1)

Peking university Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Conditions

Hyperuricemia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: November 9, 2020
• Study Start: November 11, 2020
• Primary Completion: December 21, 2021
• Study Completion: June 7, 2022
• Last Updated: August 5, 2024

Record last verified: 2021-11

Locations

CN (1)