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Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of OMS1620

5. september 2026 oppdatert av: OMass Therapeutics Australia Proprietary Ltd

A Randomized, Phase 1, Double-blind, Single and Multiple-Ascending Dose and Food Effect Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of OMS1620 in Healthy Participants

The goal of this study is to explore the safety, drug concentrations and effects on adrenal gland hormones after a single dose or multiple doses of OMS1620 in healthy participants. In addition, the effect of food on drug concentrations will also be tested.

Studieoversikt

Status

Har ikke rekruttert ennå

Studietype

Intervensjonell

Registrering (Antatt)

84

Fase

  • Fase 1

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

  • Voksen

Tar imot friske frivillige

Ja

Beskrivelse

Key Inclusion Criteria:

  • Body mass index (BMI) 18.0 to 32.0 kg/m2 (inclusive) and weight ≥45.0 kg
  • Females must be either postmenopausal, surgically sterile or consistently use highly effective methods of contraception from 30 days prior to Day -1 until at least 30 days after the end of the study.
  • Females must not be pregnant or lactating
  • Males participants who are sexually active with female partners who are females of childbearing potential must use at least two medically effective methods of contraception from Screening through 90 days after the last dose of study drug
  • Medically healthy with no significant medical history, physical examination, laboratory, vital signs, or ECG findings, as deemed by the Investigator or qualified designee

Key Exclusion Criteria:

  • Use of systemic glucocorticoid therapies within 3 months prior to Screening or use of local glucocorticoid therapies (nasal, topical or inhaled) within 1 month prior to Screening
  • Use of mineralocorticoid therapies within 3 months prior to Screening
  • Current use of oral hormonal contraceptives. Extended cycle (e.g., ≥3 month) injectable, or implantable hormonal contraceptives are permissible, provided the cycle will not end during the conduct of the study
  • Any other condition or prior therapy, that, in the opinion of the Investigator, interferes with the participant's ability to safely complete the study or adhere to study requirements

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Grunnvitenskap
  • Tildeling: Randomisert
  • Intervensjonsmodell: Sekvensiell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Single Ascending Dose (SAD)
OMS1620 is an oral small molecule antagonist of the melanocortin 2 receptor (MC2R), the receptor for adrenocorticotrophic hormone (ACTH). OMS1620 or placebo will be given as a single dose.
OMS1620 is an oral small molecule antagonist of the melanocortin 2 receptor (MC2R), the receptor for adrenocorticotrophic hormone (ACTH)
matched placebo control for OMS1620
Eksperimentell: Multiple Ascending Dose (MAD)
OMS1620 is an oral small molecule antagonist of the melanocortin 2 receptor (MC2R), the receptor for adrenocorticotrophic hormone (ACTH). OMS1620 or placebo will be given in multiple doses.
OMS1620 is an oral small molecule antagonist of the melanocortin 2 receptor (MC2R), the receptor for adrenocorticotrophic hormone (ACTH)
matched placebo control for OMS1620
Eksperimentell: Food Effect (FE)
OMS1620 is an oral small molecule antagonist of the melanocortin 2 receptor (MC2R), the receptor for adrenocorticotrophic hormone (ACTH). OMS1620 or placebo will be given as a single dose on two separate occasions, once while fasted and once with a high-fat meal.
OMS1620 is an oral small molecule antagonist of the melanocortin 2 receptor (MC2R), the receptor for adrenocorticotrophic hormone (ACTH)

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Safety and tolerability as measured by incidence of treatment-emergent adverse events (AEs) and serious adverse events (SAEs)
Tidsramme: From Day 1 to approximately day 25
From Day 1 to approximately day 25
Food Effect (FE) on Pharmacokinetics (PK) of OMS1620 as assessed by maximum concentration (Cmax) in plasma
Tidsramme: Two separate assessments (one fasted, one after a high fat meal) of 7 days duration
Two separate assessments (one fasted, one after a high fat meal) of 7 days duration
Food Effect (FE) on Pharmacokinetics (PK) of OMS1620 as assessed by area under the plasma concentration versus time curve (AUC) in plasma
Tidsramme: Two separate assessments (one fasted, one after a high fat meal) of 7 days duration
Two separate assessments (one fasted, one after a high fat meal) of 7 days duration

Sekundære resultatmål

Resultatmål
Tidsramme
Safety and tolerability as measured by incidence of treatment-emergent adverse events (AEs) and serious adverse events (SAEs)
Tidsramme: enrollment to approximately Day 25
enrollment to approximately Day 25
Pharmacokinetics (PK) of OMS1620 as assessed by maximum concentration (Cmax) in plasma
Tidsramme: Day 1 to Day 7 (SAD) or Day 1 to Day 11 (MAD)
Day 1 to Day 7 (SAD) or Day 1 to Day 11 (MAD)
Pharmacokinetics (PK) of OMS1620 as assessed by area under the plasma concentration versus time curve (AUC) in plasma
Tidsramme: Day 1 to Day 7 (SAD) or Day 1 to Day 11 (MAD)
Day 1 to Day 7 (SAD) or Day 1 to Day 11 (MAD)

Andre resultatmål

Resultatmål
Tidsramme
Pharmacodynamics of OMS1620 as measured by the blood concentrations of adrenal hormone secretion following adrenocorticotrophic hormone (ACTH) stimulation compared to placebo
Tidsramme: D 1 (SAD) and Day 10 (MAD)
D 1 (SAD) and Day 10 (MAD)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

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 (Antatt)

1. september 2026

Primær fullføring (Antatt)

1. mai 2027

Studiet fullført (Antatt)

1. juni 2027

Datoer for studieregistrering

Først innsendt

10. august 2026

Først innsendt som oppfylte QC-kriteriene

5. september 2026

Først lagt ut (Faktiske)

9. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. september 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

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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