- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07811089
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of OMS1620
5. september 2026 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
84
Fase
- Fase 1
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde 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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Sekventiel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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
|
|
Eksperimentel: 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
|
|
Eksperimentel: 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)
|
Hvad måler undersøgelsen?
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)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. september 2026
Primær færdiggørelse (Anslået)
1. maj 2027
Studieafslutning (Anslået)
1. juni 2027
Datoer for studieregistrering
Først indsendt
10. august 2026
Først indsendt, der opfyldte QC-kriterier
5. september 2026
Først opslået (Faktiske)
9. september 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
9. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. september 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Urogenitale sygdomme
- Sygdomme i det endokrine system
- Mandlige urogenitale sygdomme
- Urogenitale sygdomme hos kvinder
- Kvinders urogenitale sygdomme og graviditetskomplikationer
- Metabolisme, medfødte fejl
- Genetiske sygdomme, medfødte
- Metaboliske sygdomme
- Gonadale lidelser
- Medfødte abnormiteter
- Binyresygdomme
- Forstyrrelser i seksuel udvikling
- Urogenitale abnormiteter
- Steroid metabolisme, medfødte fejl
- Adrenogenital syndrom
- Medfødte, arvelige og neonatale sygdomme og abnormiteter
- Ernæringsmæssige og metaboliske sygdomme
- Adrenal hyperplasi, medfødt
Andre undersøgelses-id-numre
- OMS1620-101
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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