Healthy volunteers (no specific condition studied at this stage). Therapeutic area: Rheumatology. Other
Conditions
Interventions
Test product: Hyaluronyl carnosine amide solution (FID-136) 500 mg ready-to-use oral solution (stick pack), Fidia Farmaceutici S.p.A., Italy. In both study parts, to guarantee their safety, the partic
they will be divided into subgroups. Each cohort will receive the scheduled dose of investigational medicinal product, as follows:
Cohort 1: 500 mg (D1): one stick pack of FID-136 500 mg oral solutio
Sponsors
Fidia Farmaceutici (Italy)
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Informed consent: signed written informed consent before inclusion in the study 2. Sex and age: men/women, 18-64 years old inclusive 3. Body Mass Index (BMI): 18.5-30 kg/m² inclusive 4. Vital signs: systolic blood pressure 100-139 mmHg, diastolic blood pressure 50-89 mmHg, heart rate 50-99 bpm, measured after 5 min at rest in the sitting position 5. Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to cooperate with the Investigator and to comply with the requirements of the entire study 6. Contraception and fertility (women only): women of non-child-bearing potential or in post-menopausal status for at least 1 year, defined as such when there is either: 6.1. 12 months of spontaneous amenorrhea or 6.2. 6 weeks documented postsurgical bilateral oophorectomy with or without hysterectomy will be admitted. For all women, pregnancy test results must be negative at screening and on Day -1 of each study part. 7. Contraception (men only): males will either be sterile or agree to use one of the following approved methods of contraception from the first investigational medicinal product administration until at least 90 days after the last administration, also in case their partner is currently pregnant: 7.1. A male condom with spermicide 7.2. A sterile sexual partner or a partner in post-menopausal status for at least 1 year 7.3. Use by the female sexual partner of an intra-uterine device, a female condom with spermicide, a contraceptive sponge with spermicide, a diaphragm with spermicide, a cervical cap with spermicide, or hormonal oral, implantable, transdermal, or injectable contraceptives for at least 2 months before the screening visit or: True abstinence (i.e., refraining from heterosexual intercourse when this is in line with the preferred and usual lifestyle of the participant). Periodic abstinence (e.g., calendar, ovulation, thermal symptoms, post-ovulation methods), female sexual partner lactational amenorrhea, and withdrawal are not acceptable. Men must agree to inform their partners of the participation in the clinical study. Furthermore, they will not donate sperm from the date of the informed consent form’s signature, throughout the study, and for at least 90 days after the last dose of the study treatment.
Exclusion criteria
Exclusion criteria: 1. Electrocardiogram (ECG) 12-leads (supine position): clinically significant abnormalities 2. Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study 3. Laboratory analyses: clinically significant abnormal laboratory values at screening indicative of physical illness 4. Diseases: significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that may interfere with the aim of the study 5. C-reactive protein: abnormal and clinically relevant at screening 6. Allergy: ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may affect the outcome of the study 7. Medications: non-steroidal anti-inflammatory drugs for one month or corticosteroids for 3 months or medications, including over-the-counter (OTC) medications, homeopathic preparations, vitamins, food supplements and herbal remedies for 3 weeks before the start of the study 8. Investigative drug studies: participation in the evaluation of any investigational product for 3 months before this study. The 3-month interval is calculated as the time between the first calendar day of the month that follows the last visit of the previous study and the first day of the present study 9. Blood donation: blood donations for 3 months before this study 10. Drug, alcohol, caffeine, tobacco: history of drug, alcohol (>1 drink/day for females and >2 drinks/day for men, defined according to the USDA Dietary Guidelines 2020-2025) caffeine (>5 cups coffee/tea/day) or tobacco (=10 cigarettes/day) abuse 11. Drug test: positive result at the urine drug screening test at screening or Day -1 12. Alcohol test: positive alcohol saliva test at screening or Day -1 13. Diet: abnormal diets (3500 kcal/day) or substantial changes in eating habits in the 4 weeks before this study; vegetarians and vegans; grapefruit or grapefruit juice for 48 h before the first investigational medicinal product administration 14. Pregnancy (women only): positive or missing pregnancy test at screening or Day -1; childbearing potential, pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment-emergent adverse events measured using adverse events monitoring at throughout the whole study;Vital signs (blood pressure, heart rate) measured using a sphygmomanometer at Study Part A: at Screening; Day -1; Day 1, before the morning administration (0) and 3, 4, 7 and 9 h after the morning administration; Day 2 at 24 h after the morning administration (Final visit measure)/ETV; Follow-up visit. Study Part B: at Screening; Day -1; on Day 1-2 and Day 14-15, at pre-dose (0) and 3, 4, 7, 9 and 24 h after the morning administration of Days 1 and 14; Day 3-13 at pre-dose in the morning ; ETV; Follow-up visit;Body weight measured using an electronic weighing scale at Study Part A: at Screening; Final visit/ETV; Follow-up Visit 6 (Day 8±1). Study Part B: at Screening; Day 2 at pre-dose, within a window of 1 h before dosing; Day 15 at 24 ± 1 h after the last morning administration (Final visit measure)/ETV ; Follow-up Visit 6 (Day 21±2);Physical examinations results measured using visual physical examination at Study Part A: at Screening; Final visit/ETV; Follow-up Visit 6 (Day 8±1). Study Part B: at Screening; Final visit/ETV ; Follow-up Visit 6 (Day 21±2);Clinical laboratory tests results (haematology, coagulation, blood chemistry and urinalysis) measured using clinical laboratory parameters analysis of venous blood samples collected from participants’ forearm veins at Study Part A: at Day 2 at 24 ± 1 h after the morning administration (Final visit/ETV); Follow-up visit. Study Part B: at Day 2 at pre-dose, within a window of 1 h before dosing; Day 15 at 24 ± 1 h post the last morning administration (Final visit/ETV).;ECG recording measured using 12-lead ECGs recorded in supine position after 5 min at rest through an electrocardiograph at Study Part A: at Screening; Day -1, applicable to D2 only; Day 1 at pre-dose, applicable to D1 only, and 7 h after the morning administration; Final visit/ETV; Follow-up visit. Study Part B: at Screening; Day -1, applicable | — |
Secondary
| Measure | Time frame |
|---|---|
| Part A. FID-136 main metabolites’ concentration and pharmacokinetic profile in plasma (Cmax, tmax, AUC0-t and other parameters as appropriate) after single dose of FID-136 measured using venous blood samples collected from participants’ forearm veins at at pre-dose (0), 2, 6, 10, 12, 14, 16, 18, 20 and 24 h post-dose;Part A. Urine FID-136 main metabolites’ concentration, the excreted daily amount (Ae0-24) and renal clearance (Clr) measured and calculated up to 24 h after single dose of FID-136 measured using urine collection at in the intervals 0-6, 6-12, 12-18, 18-24 h post-dose;Part A. Subjective evaluation of palatability of FID-136 measured using palatability questionnaire at Day 1, 10 ± 5 min post-dose;Part B. FID-136 main metabolites’ concentration and pharmacokinetic profile in plasma (Cmax, tmax, AUC0-t and other parameters as appropriate) after the first dose of FID-136, measured using venous blood samples collected from participants’ forearm veins at at pre-dose (0) and 2, 6, 10, 12, 14, 16, 18, 20 and 24 h after the first dose;Part B. FID-136 main metabolites’ concentration and pharmacokinetic profile in plasma (Cmax,ss, tmax,ss, AUCt,ss and other parameters as appropriate) after the last repeated dose of FID-136 administered for 14 days of treatment, measured using analysing venous blood samples collected from participants’ forearm veins at at pre-dose (0) and 2, 6, 10, 12, 14, 16, 18, 20 and 24 h after the last dose;Part B. Urine FID-136 main metabolites’ concentration, the excreted daily amount (Ae0-24) and the renal clearance (Clr) after the first and the last repeated dose of FID-136 for 14 days of treatment, measured using urine collection at in the intervals 0-6, 6-12, 12-18 and 18-24 h after the first and the last morning administration;Part B. Subjective evaluation of the palatability of FID-136 measured using palatability questionnaire at Day 1 and Day 14, 10 ± 5 min post-dose;Part B, Exploratory. Measurement of the presence and concentration of | — |
Countries
Italy, Switzerland
Contacts
Public ContactNicola Giordan
Outcome results
None listed