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A Phase 1 Study of SSS17 in Healthy Subjects.

27 grudnia 2021 zaktualizowane przez: Shenyang Sunshine Pharmaceutical Co., LTD.

A Phase 1 Study to Evaluate the Tolerance, Safety, Pharmacokinetics and Pharmacodynamics of Oral Administration of SSS17 in Chinese Healthy Adult Subjects With Single and Multiple Dose Escalation and the Effect of Food on the Pharmacokinetics of SSS17.

This study will investigate the efficacy, safety, pharmacokinetics and pharmacodynamics of single oral administration of 5 mg, 15 mg, 20 mg and 25 mg of SSS17 compared with placebo, and evaluate the efficacy, safety, tolerance, pharmacokinetics and pharmacodynamics of multiple oral administration of 15 mg and 20 mg of SSS17 compared with placebo. In addition, the study will assess the effect of food on the pharmacokinetics of SSS17.

Przegląd badań

Status

Rekrutacyjny

Interwencja / Leczenie

Szczegółowy opis

The study will enroll healthy volunteers from a single academic medical center in China. All participants will be informed about the study and potential risks and required to provide written informed consent prior to undergoing study-related procedures.The study will be divided into 3 parts.

Part 1: Subjects will be allocated 2:8 to receive placebo or SSS17(it was only 2:2 in 5mg dose group),which will be administered by oral route with single dose. At each dose, tolerability, safety, PK and PD characteristics will be investigated.

Part 2: Subjects will be allocated 2:8 to receive placebo or SSS17, which will be administered by oral route with multiple dose. At each cohort,tolerability, safety, PK and PD characteristics will be investigated.

Part 3: The subjects will receive two cycles of treatment, one is given on an empty stomach, the other is given after a high-fat meal, with an interval of 15 days.

Typ studiów

Interwencyjne

Zapisy (Oczekiwany)

76

Faza

  • Faza 1

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

  • Nazwa: Professor Fang, Ph.D
  • Numer telefonu: 13701165926
  • E-mail: fygk7000@163.com

Lokalizacje studiów

    • Guangdong
      • Guangzhou, Guangdong, Chiny, 510700
        • Rekrutacyjny
        • The Fifth Affiliated Hospital of Guangzhou Medical University
        • Kontakt:
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 45 lat (Dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  • Chinese healthy adult subjects aged 18-45 years (including the boundary value) at the time of signing the informed consent were male and female;
  • In the screening period, the weight of male subjects was more than or equal to 50.0 kg; Female weight ≥ 45.0 kg; Body mass index (BMI) ranged from 19.0 kg / m2 to 26.0 kg / m2 (including boundary value); BMI = weight kg / height m2);
  • Within 6 months from the date of signing the informed consent to the end of the trial, female subjects agreed to take reliable measures to avoid pregnancy and ensure no birth plan, while male subjects agreed to take reliable measures to avoid pregnancy and ensure no birth plan;
  • Willing to participate in the study and sign a written informed consent, able to communicate well with the researchers, and agreed to follow the requirements of the trial protocol and follow-up on schedule.

Exclusion Criteria:

  • Participated in other drug clinical trials within 3 months before screening;
  • Have any clinical history of serious diseases or are suffering from related diseases, including but not limited to digestive system (such as diarrhea, vomiting, inflammatory bowel disease, hemorrhoids, acute gastritis, peptic ulcer, acute and chronic gastrointestinal disorders with obvious digestive and absorption disorders), cardiovascular system, respiratory system, urinary system, musculoskeletal system, endocrine system, gastrointestinal tract diseases, etc Diseases of nervous and mental system, blood system, immune system, etc; A history of any disease or thrombotic disease or vascular malformation that increases the risk of bleeding; Patients with dysphagia;
  • Allergic constitution, known allergic to test drug ingredients or allergic history to any drug or food (mango, shrimp, crab, lobster, etc.) or pollen allergy history;
  • Those who smoke more than 5 cigarettes / day or the same amount of tobacco after inquiry, or who can not ban smoking during the trial period; Or alcohol consumption per week is equal to 14 units (1 units 25mL wine Baijiu / 100mL wine / 285mL beer), or those who can not prohibit alcohol during the test period;
  • Have a history of drug abuse or drug abuse;
  • Within 6 months, there were fertility planning, sperm donation and egg donation planning;
  • Patients with lactose intolerance (those who have had diarrhea after drinking milk);
  • Those who have special requirements for diet and cannot accept unified diet;
  • Blood donors or massive blood loss (≥ 400ml), EPO treatment, blood transfusion or use of blood products within 3 months before screening;
  • Those vaccinated within 8 weeks before screening or during the study period;
  • There was a history of acupuncture and blood sickness; Or with orthostatic hypotension;
  • Those who have participated in and used the trial drug;Those who have used any prescription drug, over-the-counter drug, Chinese herbal medicine, vitamins or health care products within 14 days before screening and whose time is less than 5 half-life of the drug or less than 2 weeks (whichever is the longest);
  • The serum pregnancy test of lactating and pregnant women, or female volunteers of childbearing age was positive;
  • The results of physical examination, chest X-ray, color Doppler ultrasound, electrocardiogram and laboratory examination were abnormal and clinically significant; Or hemoglobin of male subjects was more than 175.0 g / L; Or hemoglobin of female subjects was more than 150.0 g / L; Or hemoglobin of male and female were less than 113g / L;
  • Within 48 hours before enrollment, those who took any special diet that affected the absorption, distribution, metabolism and excretion of drugs, including pitaya, mango, grapefruit, lime, carambola or food or drink prepared from them, chocolate, and any food or drink containing caffeine;
  • Urine drug screening test was positive;
  • Alcohol breath test was positive within 24 hours before administration;
  • The researchers think that there are other cases that are not suitable for the trial.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Part 1: Single Dose Escalation SSS17
Escalating doses of SSS17, single dose administration
SSS17 is a novel small molecule compound which stimulates erythropoiesis through inhibition of hypoxiainducible factor- prolyl hydroxylases( HIF-PH). It is being developed for the treatment of anemia in patients with chronic kidney disease.
Komparator placebo: Part 1: Single Dose Escalation matching Placebo
Escalating doses of matching placebo, single dose administration
Dopasowane placebo.
Eksperymentalny: Part 2: Multiple Dose Escalation SSS17
Escalating doses of SSS17, multiple dose administration
SSS17 is a novel small molecule compound which stimulates erythropoiesis through inhibition of hypoxiainducible factor- prolyl hydroxylases( HIF-PH). It is being developed for the treatment of anemia in patients with chronic kidney disease.
Komparator placebo: Part 2: Multiple Dose Escalation matching Placebo
Escalating doses of matching placebo, multiple dose administration
Dopasowane placebo.
Eksperymentalny: Part 3: Treatment Sequence 1 (A to B)
The subjects in the first cycle received oral administration of SSS17 on an empty stomach, and subjects in the second cycle received oral administration of SSS17 after a high-fat meal
SSS17 is a novel small molecule compound which stimulates erythropoiesis through inhibition of hypoxiainducible factor- prolyl hydroxylases( HIF-PH). It is being developed for the treatment of anemia in patients with chronic kidney disease.
Eksperymentalny: Part 3: Treatment Sequence 2 (B to A)
The subjects in the first cycle received oral administration of SSS17 after a high-fat meal, and the subjects in the second cycle received oral administration of SSS17 on an empty stomach
SSS17 is a novel small molecule compound which stimulates erythropoiesis through inhibition of hypoxiainducible factor- prolyl hydroxylases( HIF-PH). It is being developed for the treatment of anemia in patients with chronic kidney disease.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Part 1: AEs
Ramy czasowe: Baseline up to Days 15
Assessment AEs by frequency and severity in the part 1
Baseline up to Days 15
Part 1: Maximum plasma concentration (Cmax) of SSS17
Ramy czasowe: Up to 336 hours post-dose
Plasma samples will be collected and Cmax will be assessed in the part 1
Up to 336 hours post-dose
Part 1: Area under the concentration-time curve (AUC) of plasma concentration of SSS17
Ramy czasowe: Up to 336 hours post-dose
Plasma samples will be collected and the AUC from zero to infinity will be assessed in the part 1
Up to 336 hours post-dose
Part 1: Time-to-Cmax (Tmax) of SSS 17
Ramy czasowe: Up to 336 hours post-dose
Plasma samples will be collected and the Tmax will be assessed from the concentration-time curve in the part 1
Up to 336 hours post-dose
Part 1: Elimination terminal half-life (t1/2) of SSS17
Ramy czasowe: Up to 336 hours post-dose
Plasma samples will be collected and the t1/2 will be assessed in the part 1
Up to 336 hours post-dose
Part 1: . Total amount of SSS17 excreted in urine over 72 hours (Ae0-72)
Ramy czasowe: Up to 72 hours post-dose
Urine sample will be collected at pre-specified intervals and Ae0-72 will be assessed in the part 1
Up to 72 hours post-dose
Part 1: Fraction of SSS17 excretion during each collection interval (Fe0-72)
Ramy czasowe: Up to 72 hours post-dose
Urine sample will be collected at pre-specified intervals and Fe0-72 will be assessed in the part 1
Up to 72 hours post-dose
Part 1: Renal clearance (CLR) of SSS17
Ramy czasowe: Up to 72 hours post-dose
Urine sample will be collected at pre-specified intervals and CLR will be assessed in the part 1
Up to 72 hours post-dose
Part 2: AEs
Ramy czasowe: Up to Days 33 or 57
Assessment AEs by frequency and severity in the part 2
Up to Days 33 or 57
Part 2: Steady state minimal concentration (Css_min) of SSS17
Ramy czasowe: Up to Days 33 or 57
Plasma samples will be collected and Css_min will be assessed in the part 2
Up to Days 33 or 57
Part 2: Steady state maximum concentration (Css_max) of SSS17
Ramy czasowe: Up to Days 33 or 57
Plasma samples will be collected and Css_max will be assessed in the part 2
Up to Days 33 or 57
Part 2: Steady state average concentration (Css_av) of SSS17
Ramy czasowe: Up to Days 33 or 57
Plasma samples will be collected and Css_av will be assessed in the part 2
Up to Days 33 or 57
Part 2: Area under the concentration-time curve of plasma concentration of SSS17 within the interval of administration after reaching steady state (AUC0-τ)
Ramy czasowe: Up to Days 33 or 57
Plasma samples will be collected and the AUC from zero to τ will be assessed
Up to Days 33 or 57
Part 3: Maximum plasma concentration (Cmax) of SSS17
Ramy czasowe: Up to Days 44
Plasma samples will be collected and Cmax will be assessed in the part 3
Up to Days 44
Part 3: Area under the concentration-time curve (AUC) of plasma concentration of SSS17
Ramy czasowe: Up to Days 44
Plasma samples will be collected and the AUC from zero to infinity will be assessed in the part 3
Up to Days 44
Part 3: Time-to-Cmax (Tmax) of SSS 17
Ramy czasowe: Up to Days 44
Plasma samples will be collected and the Tmax will be assessed from the concentration-time curve in the part 3
Up to Days 44
Part 3: Elimination terminal half-life (t1/2) of SSS17
Ramy czasowe: Up to Days 44
Plasma samples will be collected and the t1/2 will be assessed in the part 3
Up to Days 44

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Part 1: EPO concentrations
Ramy czasowe: Up to 168 hours post-dose
Change of EPO concentrations from baseline following SSS17 in the part 1
Up to 168 hours post-dose
Part 1: VEGF concentrations
Ramy czasowe: Up to 168 hours post-dose
Change of VEGF concentrations from baseline following SSS17 in the part 1
Up to 168 hours post-dose
Part 1: Change of hepcidin from baseline
Ramy czasowe: Up to 168 hours post-dose
Change of serum hepcidin concentrations from baseline following SSS17 in the part 1
Up to 168 hours post-dose
Part 1: Change of RTC from baseline
Ramy czasowe: Baseline up to Days 15
Change of RTC from baseline following SSS17 in the part 1
Baseline up to Days 15
Part 1: Change of RBC from baseline
Ramy czasowe: Baseline up to Days 15
Change of RBC from baseline following SSS17 in the part 1
Baseline up to Days 15
Part 1: Change of Hgb from baseline
Ramy czasowe: Baseline up to Days 15
Change of Hgb from baseline following SSS17 in the part 1
Baseline up to Days 15
Part 2: EPO concentrations
Ramy czasowe: Up to Days 33 or 57
Change of EPO concentrations from baseline following SSS17 in the part 2
Up to Days 33 or 57
Part 2: VEGF concentrations
Ramy czasowe: Up to Days 33 or 57
Change of VEGF concentrations from baseline following SSS17 in the part 2
Up to Days 33 or 57
Part 2: Change of hepcidin from baseline
Ramy czasowe: Up to Days 33 or 57
Change of serum hepcidin concentrations from baseline following SSS17 in the part 2
Up to Days 33 or 57
Part 2: Change of RTC from baseline
Ramy czasowe: Baseline up to Days 33 or 57
Change of RTC from baseline following SSS17 in the part 2
Baseline up to Days 33 or 57
Part 2: Change of RBC from baseline
Ramy czasowe: Baseline up to Days 33 or 57
Change of RBC from baseline following SSS17 in the part 2
Baseline up to Days 33 or 57
Part 2: Change of Hgb from baseline
Ramy czasowe: Baseline up to Days 33 or 57
Change of Hgb from baseline following SSS17 in the part 2
Baseline up to Days 33 or 57
Part 3: AEs
Ramy czasowe: Up to Days 44
Assessment AEs by frequency and severity in the part 3
Up to Days 44
Part 3: EPO concentrations
Ramy czasowe: Up to Days 44
Change of EPO concentrations from baseline following SSS17 in the part 3
Up to Days 44
Part 3: VEGF concentrations
Ramy czasowe: Up to Days 44
Change of VEGF concentrations from baseline following SSS17 in the part 3
Up to Days 44
Part 3: Change of hepcidin from baseline
Ramy czasowe: Up to Days 44
Change of serum hepcidin concentrations from baseline following SSS17 in the part 3
Up to Days 44
Part 3: Change of RTC from baseline
Ramy czasowe: Baseline up to Days 44
Change of RTC from baseline following SSS17 in the part 3
Baseline up to Days 44
Part 3: Change of RBC from baseline
Ramy czasowe: Baseline up to Days 44
Change of RBC from baseline following SSS17 in the part 3
Baseline up to Days 44
Part 3: Change of Hgb from baseline
Ramy czasowe: Baseline up to Days 44
Change of Hgb from baseline following SSS17 in the part 3
Baseline up to Days 44

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

26 lipca 2021

Zakończenie podstawowe (Oczekiwany)

31 grudnia 2022

Ukończenie studiów (Oczekiwany)

30 czerwca 2023

Daty rejestracji na studia

Pierwszy przesłany

17 maja 2021

Pierwszy przesłany, który spełnia kryteria kontroli jakości

17 maja 2021

Pierwszy wysłany (Rzeczywisty)

19 maja 2021

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

13 stycznia 2022

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

27 grudnia 2021

Ostatnia weryfikacja

1 grudnia 2021

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • SYSS-SSS17-UND-I-02

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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