- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01793298
Safety, Tolerability and Pharmacokinetics of ASM-024 Administered to Healthy Subjects and Subjects With Moderate Asthma
9. februar 2015 oppdatert av: Asmacure Ltée
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of ASM-024 Administered by Dry Powder Inhalation to Healthy Subjects and Subjects With Stable Moderate Asthma
The purpose of this study is to evaluate the safety and tolerability of the dry powder formulation of ASM-024 following single and multiple administration by inhalation of ascending doses in healthy subjects and subjects with stable moderate asthma.
Studieoversikt
Detaljert beskrivelse
This is a phase I/II, randomized, double-blind, placebo-controlled study of single ascending and multiple ascending doses of ASM-024 administered by dry powder inhalation to healthy subjects and subjects with stable moderate asthma.
The goal of this study is to evaluate the safety, tolerability and pharmacokinetic profile of a new, dry powder formulation of ASM-024.
The doses that will be tested in subjects with asthma will be determined based on the information collected first in healthy volunteers.
In addition to standard safety and tolerability evaluations, the acute effects of the study medication on the airways will be assessed.
Studietype
Intervensjonell
Registrering (Faktiske)
55
Fase
- Fase 2
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Quebec
-
Québec, Quebec, Canada, G1V 4G5
- Institut Universitaire De Cardiologie Et De Pneumologie De Québec
-
Québec, Quebec, Canada, G1P 0A2
- PharmaNet
-
-
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
Alle
Beskrivelse
Inclusion Criteria:
Healthy Volunteers:
- Healthy male or female adult, 18 to 55 years of age ; non-smoker or former smoker;
- Normal lung function; and
- Normal 12-lead ECG
Asthmatics:
- Male or female adult, 18 to 60 years of age with diagnosis of moderate asthma according to the GINA Guidelines and on regular inhaled corticosteroids with or without short or long-acting beta 2-agonists;
- Non-smoker or former smoker;
- FEV1 ≥ 70 % predicted in the absence of medications for asthma;
- Baseline methacholine PC20 ≤ 16 mg/mL; and
- Normal 12-lead ECG.
Exclusion Criteria:
Healthy Volunteers:
- Clinically significant illness or surgery within 8 weeks prior to first administration of the study medication;
- Significant medical history that, in the Investigator's opinion, may adversely affect participation;
- History of allergy or significant adverse reaction to drugs similar to ASM-024, to nicotine, or to cholinergic drugs or any drugs with a similar chemical structure;
- History of hypersensitivity (anaphylaxis, angioedema) to any drug;
- Use of any drug known to induce or inhibit hepatic drug metabolism, within 30 days prior to first administration of the study medication;
- Positive pregnancy test for female subjects;
- Use of medications known to prolong QT/QTc interval within 14 days prior to the first administration of the study medication;
- Clinically significant 12 lead ECG abnormalities at Screening;;
- Clinically significant physical examination or laboratory findings at Screening;
- History of alcohol or drug abuse;
- Tobacco use within 12 months prior to Screening, or nicotine-containing products within 6 months prior to Screening. History of smoking must be ≤ 10 pack-years;
- Positive hepatitis B or C or HIV test at Screening;
- Investigational drug within 30 days prior to first administration of the study medication, or long-acting investigational drug within 90 days prior to first administration of the study medication;
- Previous exposure to ASM-024; and
- Women of child-bearing potential and male participants unwilling or unable to use accepted methods of birth control.
Asthmatics:
- Clinically significant illness or surgery within 8 weeks prior to first administration of the study medication;
- Significant medical history that, in the Investigator's opinion, may adversely affect participation;
- History of allergy or significant adverse reaction to drugs similar to ASM-024, to nicotine, or to cholinergic drugs or any drugs with a similar chemical structure;
- History of hypersensitivity (anaphylaxis, angioedema) to any drug;
- Use of any drug known to induce or inhibit hepatic drug metabolism, within 30 days prior to first administration of the study medication;
- Positive pregnancy test for female subjects;
- Use of medications known to prolong QT/QTc interval;
- Clinically significant 12 lead ECG at Screening;
- Clinically significant physical examination or laboratory findings or abnormal vital signs;
- Baseline methacholine PC20 > 16 mg/mL at Screening;
- History of illicit drug use or alcohol abuse within 12 months of Screening;
- Tobacco use within 12 months prior to Screening, or nicotine-containing products within 6 months prior to Screening. History of smoking must be ≤ 10 pack-years;
- Positive hepatitis B or C or HIV test at Screening;
- Any of the following concomitant medications preceding the administration of methacholine during Screening and preceding the administration of the study medication at Visit 1: (i) oral or i.v. corticosteroids within 1 month; (ii) inhaled or intranasal corticosteroids within 48 hours; (iii) long-acting beta-2-agonists within 48 hours; (iv) short-acting beta-2-agonists within 8 hours; (v) anticholinergic aerosol within 24 hours; (vi) theophyline-containing products within 48 hours; (vii) NSAIDs within 7 days preceding the administration of methacholine during Screening and throughout the study; and (viii) antihistaminic drugs within 3 days;
- Investigational drug within 30 days of Screening; long-acting investigational drug within 90 days of Screening;
- Previous exposure to ASM-024; and
- Women of child-bearing potential and male participants unwilling or unable to use accepted methods of birth control.
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: Crossover-oppdrag
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Healthy Subjects - ASM-024 Single Administration
Single administration of ascending doses of ASM-024
|
Ascending doses of ASM-024
|
Placebo komparator: Healthy Subjects - Placebo
Single administration of placebo
|
|
Eksperimentell: Healthy Subjects - ASM-024 Repeat Administration
Repeat administration of ascending doses of ASM-024
|
Ascending doses of ASM-024
|
Placebo komparator: Healthy Subjects - Placebo Repeat Administration
Repeat administration of ascending doses of placebo
|
|
Eksperimentell: Subjects with Asthma
Repeat administration of ascending doses of ASM-024 or placebo in a crossover fashion
|
Ascending doses of ASM-024
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
adverse events, spirometry
Tidsramme: up to 7 days
|
up to 7 days
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studiestol: Yvon Cormier, M.D., Asmacure Ltée
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
1. mars 2013
Primær fullføring (Faktiske)
1. mars 2014
Studiet fullført (Faktiske)
1. desember 2014
Datoer for studieregistrering
Først innsendt
14. februar 2013
Først innsendt som oppfylte QC-kriteriene
14. februar 2013
Først lagt ut (Anslag)
15. februar 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
10. februar 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
9. februar 2015
Sist bekreftet
1. februar 2015
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ASM-024/I-II/STA-03
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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