A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASC35 Injection in Participants With Obesity or Overweight
A Phase I, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASC35 Injection, for Subcutaneous Use (Once-monthly Formulation) in Adult Participants With Obesity or Overweight
This randomized, double-blind, placebo-controlled single ascending dose (SAD)/ multiple ascending dose (MAD) study is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ASC35 injection
Studieoversikt
Status
Forhold
Studietype
Registrering (Antatt)
Fase
- Fase 1
Kontakter og plasseringer
Studiekontakt
- Navn: Ascletis Recruiting
- Telefonnummer: +1 2068073688
- E-post: clinicaltrials@ascletis.com
Studiesteder
-
-
Maryland
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Baltimore, Maryland, Forente stater, 21201
- Rekruttering
- Ascletis Clinical Site
-
Ta kontakt med:
- Ascletis Recruiting
- E-post: clinicaltrials@ascletis.com
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Have given written informed consent to participate in this study in accordance with local regulations and the Institutional Review Boards (IRB) governing the study site.
- Are between 18 and 65 years of age (both inclusive) at time of screening.
- No clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and other screening procedures.
Exclusion Criteria:
- Have evidence of any clinically significant active or chronic disease.
- Have any prior diagnosis of diabetes mellitus (T1DM or T2DM), history of ketoacidosis, or hyperosmolar state/coma.
- Have an autoimmune disease, is immunosuppressed or is in any way immunocompromised.
- Have a history of acute or chronic pancreatitis.
- Have a known clinically significant gastric emptying abnormality.
- Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy.
- Have a history of any other condition (such as known drug or alcohol abuse, diagnosed eating disorder, or other psychiatric disorder) that, in the opinion of the Investigator, may preclude the participant from following and completing the protocol.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Sekvensiell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: SAD Cohort 1
SAD Dose 1 |
ASC35 Injection B is an investigational once-monthly formulation of ASC35 administered by subcutaneous injection. ASC35 Placebo Injection B is a placebo injection matching ASC35 Injection B |
|
Eksperimentell: SAD Cohort 2
SAD Dose 2 |
ASC35 Injection B is an investigational once-monthly formulation of ASC35 administered by subcutaneous injection. ASC35 Placebo Injection B is a placebo injection matching ASC35 Injection B |
|
Eksperimentell: SAD Cohort 3
SAD Dose 3 |
ASC35 Injection B is an investigational once-monthly formulation of ASC35 administered by subcutaneous injection. ASC35 Placebo Injection B is a placebo injection matching ASC35 Injection B |
|
Eksperimentell: SAD Cohort 4
SAD Dose 4 |
ASC35 Injection B is an investigational once-monthly formulation of ASC35 administered by subcutaneous injection. ASC35 Placebo Injection B is a placebo injection matching ASC35 Injection B |
|
Aktiv komparator: MAD Cohort 0
MAD Cohort 0 |
Tirzepatide is a once-weekly dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist administered by subcutaneous injection |
|
Eksperimentell: MAD Cohort 1
MAD Cohort 1 |
ASC35 Injection B is an investigational once-monthly formulation of ASC35 administered by subcutaneous injection. ASC35 Placebo Injection B is a placebo injection matching ASC35 Injection B |
|
Eksperimentell: MAD Cohort 2
MAD Cohort 2 |
ASC35 Injection B is an investigational once-monthly formulation of ASC35 administered by subcutaneous injection. ASC35 Placebo Injection B is a placebo injection matching ASC35 Injection B |
|
Eksperimentell: MAD Cohort 3
MAD Cohort 3 |
ASC35 Injection B is an investigational once-monthly formulation of ASC35 administered by subcutaneous injection. ASC35 Placebo Injection B is a placebo injection matching ASC35 Injection B |
|
Eksperimentell: MAD Cohort 4
MAD Cohort 4 |
ASC35 Injection B is an investigational once-monthly formulation of ASC35 administered by subcutaneous injection. ASC35 Placebo Injection B is a placebo injection matching ASC35 Injection B |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Adverse events
Tidsramme: Baseline and Day 141
|
A summary of AEs, SAEs and other non-serious adverse events |
Baseline and Day 141
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Cmax of ASC35
Tidsramme: Baseline and Day 141
|
Evaluate the peak plasma concentration of ASC35 |
Baseline and Day 141
|
|
Tmax of ASC35
Tidsramme: Baseline and Day 141
|
Evaluate the time to reach peak plasma concentration of ASC35 |
Baseline and Day 141
|
|
AUC of ASC35
Tidsramme: Baseline and Day 141
|
Evaluate the area under the plasma concentration-time curve of ASC35 |
Baseline and Day 141
|
|
Change From Baseline in Body Weight
Tidsramme: Baseline and Day 141
|
Percentage Change From Baseline in Body Weight |
Baseline and Day 141
|
|
Change From Baseline in Body Weight
Tidsramme: Baseline and Day 141
|
Actual Change From Baseline in Body Weight |
Baseline and Day 141
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ASC35-101
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
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