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New drug AG-181 tested in healthy people for first time

NCT ID NCT06286033

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial tested the safety and tolerability of a new drug called AG-181 in 88 healthy volunteers. Researchers gave single or multiple doses to see how the body processes the drug and whether it causes any side effects. The study also looked at how food affects drug levels. Since this is a Phase 1 trial in healthy people, it does not test whether the drug works for any disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AG-181

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

88 people

The number who actually took part.

Started

Feb 2024

Finished

Oct 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Willing to participate in the study, give written informed consent, and comply with the study restrictions. * Body mass index in the range of 18.0 to 30.0 kilograms per square meter (kg/m\^2). * Weight ≥ 50 kilograms (kg) at screening. * Healthy status as defined by the absence of evidence of any clinically significant, in the opinion of the Investigator, active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead electrocardiogram (ECG), hematology, blood chemistry, serology, and urinalysis. * Ability and willingness to refrain from alcohol-, caffeine-, and methylxanthine-containing beverages or food (e.g., coffee, tea, cola, chocolate, energy drinks) from 72 hours (3 days) before administration of the first dose of study drug through follow-up. * All values for hematology and clinical chemistry tests of blood and urine within the normal range or showing no clinically relevant deviations, as judged by the Investigator. * For women of child bearing potential (WOCBP)\*, have a negative serum pregnancy test at Screening and during admission to the clinic. a. \*WOCBP are defined as sexually mature women who have not undergone a hysterectomy, bilateral oophorectomy, or tubal occlusion; or who have not been naturally postmenopausal. WOCBP must use an acceptable method of contraception from Screening and until 14 days or 5 half-lives of AG-181, whichever is longer, after last dose of AG-181. WOCBP using hormonal contraception as a highly effective form of contraception must also use an acceptable barrier method. * Male participants with female partners of childbearing potential must use a condom during treatment and for 14 days or 5 half-lives of AG-181, whichever is longer, after last dose of AG-181. * Male participants must agree not to donate sperm during the study and for 14 days or 5 half-lives of AG-181, whichever is longer, after the last dose of study drug. * Postmenopausal women are women who have not menstruated at all for at least the 12 months before providing informed consent and who have an elevated follicle-stimulating hormone (FSH) level indicative of menopause during screening. * Participants must have discontinued use of prescription drugs (including topical skin preparations other than nonsteroidal/nonantibiotic nonprescription moisturizers) within 2 weeks or 5 half-lives (whichever is longer) of the first dose of study drug, and over-the-counter (OTC) medication (excluding routine vitamins) within 7 days of the first dose of study drug, unless agreed as not clinically relevant by the Investigator and Medical Monitor (or designee). Exclusion Criteria: * Women who are pregnant, lactating, or planning to attempt to become pregnant during this study or within 14 days or 5 half-lives of AG-181, whichever is longer, after last dose of study drug. * Males with female partners who are pregnant, lactating, or planning to attempt to become pregnant during this study or within 14 days or 5 half-lives of AG-181, whichever is longer, after last dose of study drug. * Prior exposure to AG-181. * Use of any investigational drug or device within 30 days before administration of the first dose of study drug. * Any disease which, in the opinion of the Investigator, poses an unacceptable risk to the participants. * Clinically significant history of, including treatment within an Emergency Department for, any drug sensitivity, drug allergy, or food allergy, as determined by the Investigator (such as anaphylaxis, hepatotoxicity, or treatment with steroids or epinephrine). * Creatinine clearance \<90 milliliters per minute (mL/min) (by Cockcroft-Gault formula) at screening. * Aspartate aminotransferase \>upper limit of normal (ULN) or alanine aminotransferase \>ULN at screening. * Use of tobacco or nicotine products in the 48 hours (2 days) prior to administration of the first dose of study drug. * Strenuous activity, sunbathing, and contact sports within 48 hours (2 days) prior to administration of the first dose of study drug. * History of donation of more than 450 milliliters (mL) of blood within 60 days prior to administration of the first dose of study drug. * Plasma or platelet donation within 7 days prior to administration of the first dose of study drug. * History within the 12 months before Screening of alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink=12 ounce (oz) beer, 5 oz wine, and 1.5 oz spirits). Alcohol consumption will be prohibited 72 hours prior to administration of the first dose of study drug and until discharge. * Positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, or anti-human immunodeficiency virus (HIV) 1 and 2 antibodies at screening. * Consumption of any nutrients known to modulate cytochrome P450 (CYP450) enzymes activity (e.g., grapefruit or grapefruit juice, pomelo juice, star fruit, or Seville \[blood\] orange products) within 14 days prior to administration of the first dose of study drug. * Positive alcohol or drug screen (cannabinoids, amphetamines, methamphetamines, 3,4-methylenedioxy-N-methylamphetamine \[ecstasy\], opiates, methadone, oxycodone, phencyclidine, cocaine, cotinine, benzodiazepines, and barbiturates) at screening or admission to the clinical facility. * Prolonged heart rate-corrected QT interval (QTc) \[heart rate-corrected QT interval by Fridericia's formula (QTcF) \>450 milliseconds (msec)\] during screening and prior to first dose of study drug. * History of long-QT syndrome, torsade de pointes, or any risk factors for torsades de pointes in the opinion of the investigator. * A history in any family member of any of the following: sudden cardiac death, unexplained death, long-QT syndrome, or death from a primary dysrhythmia potentially associated with QT prolongation.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • ICON 1255 East 3900 South

    Salt Lake City, Utah, 84124, United States

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