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A Phase 1 Study of SSS17 in Healthy Subjects.

27. Dezember 2021 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Voraussichtlich)

76

Phase

  • Phase 1

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

  • Name: Professor Fang, Ph.D
  • Telefonnummer: 13701165926
  • E-Mail: fygk7000@163.com

Studienorte

    • Guangdong
      • Guangzhou, Guangdong, China, 510700
        • Rekrutierung
        • The Fifth Affiliated Hospital of Guangzhou Medical University
        • Kontakt:
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 45 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Placebo-Komparator: Part 1: Single Dose Escalation matching Placebo
Escalating doses of matching placebo, single dose administration
Passendes Placebo.
Experimental: 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.
Placebo-Komparator: Part 2: Multiple Dose Escalation matching Placebo
Escalating doses of matching placebo, multiple dose administration
Passendes Placebo.
Experimental: 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.
Experimental: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Part 1: AEs
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Up to Days 44
Plasma samples will be collected and the t1/2 will be assessed in the part 3
Up to Days 44

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Part 1: EPO concentrations
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Up to Days 44
Assessment AEs by frequency and severity in the part 3
Up to Days 44
Part 3: EPO concentrations
Zeitfenster: Up to Days 44
Change of EPO concentrations from baseline following SSS17 in the part 3
Up to Days 44
Part 3: VEGF concentrations
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Baseline up to Days 44
Change of Hgb from baseline following SSS17 in the part 3
Baseline up to Days 44

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

26. Juli 2021

Primärer Abschluss (Voraussichtlich)

31. Dezember 2022

Studienabschluss (Voraussichtlich)

30. Juni 2023

Studienanmeldedaten

Zuerst eingereicht

17. Mai 2021

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

17. Mai 2021

Zuerst gepostet (Tatsächlich)

19. Mai 2021

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

13. Januar 2022

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

27. Dezember 2021

Zuletzt verifiziert

1. Dezember 2021

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • SYSS-SSS17-UND-I-02

Plan für individuelle Teilnehmerdaten (IPD)

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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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