Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of OMS1620

NCT07811089 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: OMS1620-101
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Congenital Adrenal Hyperplasia (CAH)

Outcome Measures

Primary Outcomes (3)

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

  From Day 1 to approximately day 25

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

  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

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

Secondary Outcomes (3)

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

  enrollment to approximately Day 25

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

  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

  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

  D 1 (SAD) and Day 10 (MAD)

Study Arms (3)

Single Ascending Dose (SAD)

EXPERIMENTAL

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.

Drug: OMS1620; Drug: Placebo

Multiple Ascending Dose (MAD)

EXPERIMENTAL

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.

Drug: OMS1620; Drug: Placebo

Food Effect (FE)

EXPERIMENTAL

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.

Drug: OMS1620

Interventions

OMS1620 DRUG

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

Food Effect (FE); Multiple Ascending Dose (MAD); Single Ascending Dose (SAD)

Placebo DRUG

matched placebo control for OMS1620

Multiple Ascending Dose (MAD); Single Ascending Dose (SAD)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• OMass Therapeutics Australia Proprietary Ltd: lead
• OMass Therapeutics: collaborator

MeSH Terms

Conditions

Adrenal Hyperplasia, Congenital

Condition Hierarchy (Ancestors)

Adrenogenital Syndrome; Disorders of Sex Development; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Steroid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Adrenal Gland Diseases; Endocrine System Diseases; Gonadal Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2026
• First Posted: September 9, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 9, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share