Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

A Phase 1 Study of SSS17 in Healthy Subjects.

27 december 2021 bijgewerkt door: 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.

Studie Overzicht

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Verwacht)

76

Fase

  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

  • Naam: Professor Fang, Ph.D
  • Telefoonnummer: 13701165926
  • E-mail: fygk7000@163.com

Studie Locaties

    • Guangdong
      • Guangzhou, Guangdong, China, 510700
        • Werving
        • The Fifth Affiliated Hospital of Guangzhou Medical University
        • Contact:
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 45 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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-vergelijker: Part 1: Single Dose Escalation matching Placebo
Escalating doses of matching placebo, single dose administration
Overeenkomende placebo.
Experimenteel: 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-vergelijker: Part 2: Multiple Dose Escalation matching Placebo
Escalating doses of matching placebo, multiple dose administration
Overeenkomende placebo.
Experimenteel: 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.
Experimenteel: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Part 1: AEs
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Up to Days 44
Plasma samples will be collected and the t1/2 will be assessed in the part 3
Up to Days 44

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Part 1: EPO concentrations
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Up to Days 44
Assessment AEs by frequency and severity in the part 3
Up to Days 44
Part 3: EPO concentrations
Tijdsspanne: Up to Days 44
Change of EPO concentrations from baseline following SSS17 in the part 3
Up to Days 44
Part 3: VEGF concentrations
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Baseline up to Days 44
Change of Hgb from baseline following SSS17 in the part 3
Baseline up to Days 44

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

26 juli 2021

Primaire voltooiing (Verwacht)

31 december 2022

Studie voltooiing (Verwacht)

30 juni 2023

Studieregistratiedata

Eerst ingediend

17 mei 2021

Eerst ingediend dat voldeed aan de QC-criteria

17 mei 2021

Eerst geplaatst (Werkelijk)

19 mei 2021

Updates van studierecords

Laatste update geplaatst (Werkelijk)

13 januari 2022

Laatste update ingediend die voldeed aan QC-criteria

27 december 2021

Laatst geverifieerd

1 december 2021

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • SYSS-SSS17-UND-I-02

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren