- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT05574166
A Phase I Study to Evaluate Safety and Pharmacokinetics of Escalating Single Doses and Multiple Doses of SP-8356
6. oktober 2022 oppdatert av: Shin Poong Pharmaceutical Co. Ltd.
A Phase I Single-Centre, Randomised, Double-Blind, Placebo-Controlled Study in Healthy Volunteers to Evaluate the Safety, Tolerability, and Pharmacokinetics of Escalating Single Doses and Multiple Doses of SP-8356
This is a 2-part, single-centre, randomised study in healthy males.
Part 1 is a double-blind, randomised, placebo-controlled, single ascending dose (SAD) study in healthy males.
Part 2 is a double-blind, randomised, placebo-controlled, multiple ascending dose (MAD) study in healthy males.
Studieoversikt
Status
Avsluttet
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
2-part, single-centre, randomised study in healthy males.
Part 1 is a double-blind, randomised, placebo-controlled, single ascending dose (SAD) study in healthy males.
Part 2 is a double-blind, randomised, placebo-controlled, multiple ascending dose (MAD) study in healthy males.
Studietype
Intervensjonell
Registrering (Faktiske)
31
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Mere Way Ruddington Fields Ruddington
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Nottingham, Mere Way Ruddington Fields Ruddington, Storbritannia, NG11 6JS
- Quotient Sciences
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 55 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Mann
Beskrivelse
Inclusion Criteria:
- Healthy males
- Aged 18 to 55 years, inclusive, at the time of signing informed consent
- Body mass index (BMI) of 18.0 to 32.0 kg/m2 as measured at screening
- Must be willing and able to communicate and participate in the whole study
- Must provide written informed consent
- Must agree to adhere to the contraception requirements
Exclusion Criteria:
- Females
- Subjects who have received any IMP in a clinical research study within the 90 days prior to the planned first dosing date
- Subjects who are, or are immediate family members of a study site or sponsor employee
- Evidence of recent or current SARS-CoV-2 infection. A minimum period of 3 months from resolution of COVID-19 symptoms to dosing must have passed
- Subjects who have previously been administered IMP in this study.
- Subjects who have taken part in Part 1 are not permitted to take part in Part 2
- History of any drug or alcohol abuse in the past 2 years
- Regular alcohol consumption in males > 21 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 Units = 125 mL glass of wine, depending on type)
- A confirmed positive alcohol breath test at screening or admission
- Current smokers and those who have smoked within the last 12 months. A confirmed breath carbon monoxide reading of greater than 10 ppm at screening or admission
- Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
- Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening
- Clinically significant abnormal biochemistry, haematology, or urinalysis as judged by the investigator. Subjects with Gilbert's Syndrome are not allowed
- Subjects that have either a known of family history of QT prolongation or chronic QT prolongation syndrome (i.e. QTc > 450 msec) in repeated ECG
- Subjects with any clinically significant medical disorders increasing tendency to bleed easily, or having history of recent trauma or surgery, or having history of gout or renal stones
- Subjects with a clinically significant history of skin disorder such as photosensitivity, eczema or psoriasis.
- Subjects with a clinically significant history of eye disorders that may affect the interpretation of the ophthalmology assessments as per the judgement of the investigator (only for subjects where ophthalmology assessments will be performed).
- Confirmed positive drugs of abuse test result
- Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody results
- Evidence of renal impairment at screening, as indicated by an estimated glomerular filtration rate (eGFR) of <80 mL/min/1.73 m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
- History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, as judged by the investigator
- Subjects with a history of cholecystectomy or gall stones (Part 1 Cohort 3 only)
- Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
- Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active
- Donation or loss of greater than 400 mL of blood within the previous 3 months
- Has a history of photosensitivity or photoallergy
- Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies (other than up to 4 g of paracetamol per day) in the 14 days before IMP administration Exceptions may apply on a case by case basis, if considered not to interfere with the objectives of the study, as determined by the investigator
- Is taking medication known to cause phototoxic reactions (e.g., tetracyclines, thiazides, nonsteroidal anti-inflammatory drugs) within 4 weeks of enrolling into the study
- Failure to satisfy the investigator of fitness to participate for any other reason
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: SP-8356 powder
Part1 will consist of escalating single doses in five sequential cohorts.
Each dose level cohort will consist of 8 subjects: 6 subjects will receive SP-8356 and 2 subjects will receive placebo in fasted state according to the randomization schedule.
Subjects in Cohort 3 will receive a single dose of SP-8356 or placebo in the fasted then fed state on separate dosing occasions.
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SP-8356 demonstrates anti-atherosclerotic and anti-ischaemic activity as a novel CD147 inhibitor.
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Placebo komparator: Placebo
Part1 will consist of escalating single doses in five sequential cohorts.
Each dose level cohort will consist of 8 subjects: 6 subjects will receive SP-8356 and 2 subjects will receive placebo in fasted state according to the randomization schedule.
Subjects in Cohort 3 will receive a single dose of SP-8356 or placebo in the fasted then fed state on separate dosing occasions.
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Placebo for SP-8356 powder
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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(Part 1)To investigate the safety and tolerability of single oral doses of SP-8356 in healthy male subjects
Tidsramme: up to 3days
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Incidence of adverse events (AEs), and assessment of physical examinations, safety laboratory tests, vital signs, electrocardiograms (ECGs) and ophthalmologic examinations
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up to 3days
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
(Part 1)To characterise the pharmacokinetic (PK) profile of single oral doses of SP-8356 Maximum Observed Drug Concentration (Cmax)
Tidsramme: up to 3days
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Evaluate Maximum Observed Drug Concentration (Cmax) of SP-8356.
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up to 3days
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(Part 1)]To characterise the pharmacokinetic (PK) profile of single oral doses of SP-8356- Area under the plasma concentration versus time curve from time zero to infinity (AUC[0-∞])
Tidsramme: up to 3days
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Evaluate Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-∞]) of SP-8356.
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up to 3days
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(Part 1)To characterise the effect of food on the PK profile of SP-8356 following single oral doses of SP-8356 Maximum Observed Drug Concentration (Cmax)
Tidsramme: up to 3days
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Evaluate the effect of food on Maximum Observed Drug Concentration (Cmax) of SP-8356.
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up to 3days
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(Part 1)To characterise the effect of food on the PK profile of SP-8356 following single oral doses of SP-8356 - Area under the plasma concentration versus time curve from time zero to infinity (AUC[0-∞])
Tidsramme: up to 3days
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Evaluate the effect of food on Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-∞]) of SP-8356.
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up to 3days
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Stuart Mair, MD, PhD, Quotient Sciences
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
3. januar 2021
Primær fullføring (Faktiske)
28. oktober 2021
Studiet fullført (Faktiske)
29. oktober 2021
Datoer for studieregistrering
Først innsendt
6. oktober 2022
Først innsendt som oppfylte QC-kriteriene
6. oktober 2022
Først lagt ut (Faktiske)
10. oktober 2022
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
10. oktober 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
6. oktober 2022
Sist bekreftet
1. oktober 2022
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SP-8356-1001
- 2020-001216-23 (EudraCT-nummer)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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