ClinicalTrials.gov record NCT07811089

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of OMS1620

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

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

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.

Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.

PhasePhase 1An early-stage study, usually small, mainly to check safety, side effects and how much of a treatment can be given. Whether it works is not the main question yet.

Healthy volunteersAcceptedPeople who do not have the condition being studied who are allowed to take part. Some studies include both people with the condition and healthy volunteers; others may enrol only healthy volunteers.

Age18 years old to 55 years old

SexAll

AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This randomized, triple-masked Phase 1 study gives single or multiple oral doses of OMS1620 or placebo to healthy participants. It will collect safety data, measure how the drug is absorbed and cleared, assess effects on adrenal gland hormones, and test how a high-fat meal changes drug levels. The study has single ascending dose, multiple ascending dose, and food-effect parts.

What it is studying. The study is testing the safety and tolerability of OMS1620, how the body handles the drug (pharmacokinetics), its effects on adrenal gland hormones, and the impact of food on drug levels.

What the researchers hope to learn. To evaluate safety and tolerability of OMS1620; to measure pharmacokinetics (including Cmax and AUC) after single and multiple doses; to assess pharmacodynamic effects on adrenal hormones; and to determine the effect of a high-fat meal on OMS1620 plasma levels.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug: OMS1620
Placebo

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants are given OMS1620 or placebo as either a single dose or multiple doses, depending on the study arm; the food‑effect arm receives OMS1620 on two occasions (once fasted and once after a high‑fat meal). Blood samples will be taken to measure drug concentrations in plasma and to assess pharmacokinetics (maximum concentration and area under the curve) over about 7 days for single‑dose groups or about 11 days for multiple‑dose groups. Safety and tolerability are monitored from Day 1 to approximately Day 25, with clinic visits to record adverse events and perform safety assessments. The registry record does not provide additional details about other procedures, questionnaires, or participant services.

How the study is structured. Interventional Phase 1, randomized and triple-masked. Participants receive OMS1620 or matched placebo in one of three parts: a single ascending dose (SAD) part, a multiple ascending dose (MAD) part, and a food-effect (FE) part. In SAD and MAD participants receive single or repeated oral doses (with placebo control); in FE participants receive OMS1620 as a single dose on two occasions, once fasted and once after a high-fat meal. Key outcomes include safety/tolerability and pharmacokinetic measures (Cmax and AUC) measured over the timeframes listed in the registry.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

Some participants receive a placebo. How is that decided, and what happens for placebo-group participants when the study ends?
This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
The registry says recruitment has not started. When is it expected to open, and can I register interest now?
No sites are listed on the registry yet. Where will the study take place?
Which of the eligibility criteria would need to be checked with tests before I could join?

More on congenital adrenal hyperplasia

Clinical trials43 trials listed for congenital adrenal hyperplasiaEvery trial the registry lists for congenital adrenal hyperplasia, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in congenital adrenal hyperplasia researchLatest monthly update: September 2026. Includes: Bedtime hydrocortisone. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start: September 2026 (estimated)
Primary completion: May 2027 (estimated)
Study completion: June 2027 (estimated)
Target enrollment: 84 participants (estimated)
Last updated on registry: Sep 9, 2026
Data verified: Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor: OMass Therapeutics Australia Proprietary Ltd
Collaborators: OMass Therapeutics

Participating sites

Study locations have not been posted on ClinicalTrials.gov yet. This study is not yet recruiting, so sites may be added when recruitment begins.

Terms used on this page · explanations by MedicalUpdates.ai

childbearing potential: Studies often ask participants who could become pregnant, or could father a child, to use contraception during the study and for a period afterwards, because the effect of the treatment on a pregnancy is unknown.
study drug: A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
ECG: A recording of the heart's electrical activity. QTc is one measurement from it; some drugs are avoided if it is prolonged.
glucocorticoid: Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
prior to Screening: The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
prior therapy: Treatment a person has already had for the condition. A 'line of therapy' is one course of treatment; studies often require, or limit, the number of prior lines.
Key Inclusion Criteria: The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Key Exclusion Criteria: The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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