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NCT Number: NCT07811089

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of OMS1620

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OMS1620

Drug

OMS1620 is an oral small molecule antagonist of the melanocortin 2 receptor (MC2R), the receptor for adrenocorticotrophic hormone (ACTH)

Placebo

Drug

matched placebo control for OMS1620

Primary outcomes

  1. Safety and tolerability as measured by incidence of treatment-emergent adverse events (AEs) and serious adverse events (SAEs)

    Time frame: From Day 1 to approximately day 25

  2. Food Effect (FE) on Pharmacokinetics (PK) of OMS1620 as assessed by maximum concentration (Cmax) in plasma

    Time frame: Two separate assessments (one fasted, one after a high fat meal) of 7 days duration

  3. Food Effect (FE) on Pharmacokinetics (PK) of OMS1620 as assessed by area under the plasma concentration versus time curve (AUC) in plasma

    Time frame: Two separate assessments (one fasted, one after a high fat meal) of 7 days duration

Secondary outcomes

  1. Safety and tolerability as measured by incidence of treatment-emergent adverse events (AEs) and serious adverse events (SAEs)

    Time frame: enrollment to approximately Day 25

  2. Pharmacokinetics (PK) of OMS1620 as assessed by maximum concentration (Cmax) in plasma

    Time frame: Day 1 to Day 7 (SAD) or Day 1 to Day 11 (MAD)

  3. Pharmacokinetics (PK) of OMS1620 as assessed by area under the plasma concentration versus time curve (AUC) in plasma

    Time frame: Day 1 to Day 7 (SAD) or Day 1 to Day 11 (MAD)

Other outcomes

  1. Pharmacodynamics of OMS1620 as measured by the blood concentrations of adrenal hormone secretion following adrenocorticotrophic hormone (ACTH) stimulation compared to placebo

    Time frame: D 1 (SAD) and Day 10 (MAD)

Sponsors and collaborators

Lead sponsor

OMass Therapeutics Australia Proprietary Ltd

Industry

Collaborators

  • OMass Therapeutics

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 9, 2026
Registry last updated
Sep 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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