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New drug aims to speed up recovery from anesthesia muscle relaxants

NCT ID NCT07595393

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Phase 2 trial tests amogammadex sodium, a drug designed to reverse the effects of common muscle relaxants (rocuronium or vecuronium) used during surgery. About 64 adults having elective surgery will receive the drug at the end of their procedure. Researchers will measure how quickly muscle strength returns and monitor for any side effects. The goal is to find the best dose for future larger studies.

What this could mean

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

Active substance
amogammadex sodium
What this could lead to
If successful, this could provide a faster, safer way to reverse muscle relaxants after surgery, helping patients recover muscle strength more quickly.
What could go wrong
This is an early Phase 2 dose-finding study with only 64 participants. It may not show clear benefit or could have unexpected side effects. Results may not apply to all surgical patients.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 64 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

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 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: 1. Participants should be willing to participate in the clinical study; the participants should fully understand and know this study and sign an informed consent form; the participants should be willing to follow and be able to complete all study procedures. 2. Male or female, 18 ≤ age ≤ 60. 3. Participant with the grade of American Society of Anaesthesiologists (ASA) physical status classification 1-2. 4. Participants who are scheduled to undergo approximately 2-hour surgery under TIVA with endotracheal intubation, and for whom vecuronium or rocuronium bromide is planned as the sole neuromuscular blocking agent. 5. Body mass index (BMI) between 18 and 32 kg/m2 (both exclusive), and weight ≥ 50 kg for males and ≥ 45 kg for females. 6. Willingness to use adequate contraception (abstinence is acceptable if it aligns with lifestyle) and refrain from pregnancy, impregnating a partner, or donating sperm/ova from screening until 3 months after study completion. Females of nonchildbearing potential are exempt. 1)For females of childbearing potential: an adequate method of contraception is defined as the use of a condom by the male partner combined with the use of a highly effective method of contraception, either be sexually inactive (abstinent) for 28 days prior to the first dose and throughout the study, or be using one of the following acceptable birth control methods: 1. Intrauterine device in place for at least 3 months prior to dosing with a barrier method (condom or diaphragm) and spermicide (if available) throughout the study 2. Double barrier methods (e.g., condom and diaphragm) with spermicide (if available) for at least 28 days prior to dosing and throughout the study 3. Surgical sterilization of the partner (vasectomy for 6 months minimum) with a barrier method (e.g., condom or diaphragm) and spermicide (if available) throughout the study. 4. Bilateral tubal occlusion (e.g. Essure-non-surgical sterility procedure and Bilateral tubal ligation), and/or a vasectomized partner with documented azoospermia 90 days after procedure, if that partner is the sole sexual partner. 2)For males: An adequate method of contraception is defined as use of a condom combined with the use of a highly effective method of contraception by the female partner of childbearing potential. Non-sterilized males with a female partner of childbearing potential must agree to use a double barrier method of birth control until five half-lives plus 90 days after the administration of the study drug. 7.Female participants must be non-pregnant (confirmed by a negative serum at screening and urine pregnancy test on Day -1), non-lactating, or be of nonchildbearing potential (females who have been postmenopausal \[defined as 24 months of amenorrhea in the absence of other biological cause\] or are surgically sterile \[hysterectomy or bilateral oophorectomy or bilateral complete salpingectomy\]). Exclusion criteria: 1. Known or expected difficult intubation due to anatomical deformities 2. Known or suspected neuromuscular diseases, anatomical abnormality or neurological injury history that may affect neuromuscular transmission. 3. History or manifestation of disease that, in the opinion of the investigator, renders the participant unsuitable for the study, including but not limited to nervous system, cardiovascular, blood, lymphatic, immune, kidney, liver, gastrointestinal, respiratory, metabolic, and musculoskeletal disorders. 4. Participants with abnormal blood pressure not satisfactorily controlled (systolic blood pressure \>160 mmHg or \< 90 mmHg, diastolic blood pressure \> 100 mmHg or \< 60 mmHg). For subjects with systolic blood pressure ≥ 140 mmHg and ≤ 160 mmHg or diastolic blood pressure ≥ 90 mmHg and ≤ 100 mmHg and a history of well-controlled blood pressure, and no definite discomfort symptoms, the determination of clinical significance will be made at investigator discretion. 5. Known heart failure or other serious cardiovascular diseases with New York Heart Association (NYHA) functional class III or IV; with abnormal ECG, QTcF interval (using Fridericia's formula) male \> 450 ms, female \> 470 ms, which is judged to have clinical significance by the investigators; with resting heart rate \< 60 bpm or \> 100 bpm, which is judged to have clinical significance by the investigators. 6. History of human immunodeficiency virus (HIV); or positive results at screening for HIV antibody/antigen (HIV Ab/Ag) 7. Hepatic insufficiency or known liver disease: 1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2.0 × upper limit of normal (ULN); 2. Known liver disease, such as acute hepatitis, chronic hepatitis (HBsAg positive with liver function abnormalities meeting the above criterion a, anti-HCV positive), liver cirrhosis, etc., deemed by the investigator as inappropriate for study inclusion. 8. kidney function impairment: Serum creatinine (Cr) \>1.5 × ULN or having previously known severe kidney diseases or Estimated Glomerular Filtration Rate (eGFR) (CKD-EPI 2021 formula) \< 60 ml/(min·1.73m²) or renal insufficiency. 9. Participants who had hereditary haemorrhagic diseases, coagulation disease, or non-traumatic bleeding history (bleeding that requires treatment), and thromboembolism; and currently have a risk of haemorrhage (including coagulation disease, thrombocytopenia \[platelet count \< 100×109/L\], thrombin original international standardized ratio \> 1.5 or on a routine anticoagulation therapy). 10. Participants known or suspected to have malignant hyperthermia or with family history; febrile illness defined as a body temperature above 37.5℃ within 7 days before administration. 11. Systemic allergic reactions caused by any known reasons, including food allergy and allergy to animals; participants known or suspected to be allergic to cyclodextrin including sugammadex, anesthetics, muscle relaxants and other drugs used in general anesthesia; participants known to be allergic to gel electrodes. 12. Participants who have taken fusidic acid and/or toremifene citrate within 24 hours prior to or scheduled within 24 hours after the study drug administration. Participants receiving drugs known to affect muscle relaxants within 24 hours before or during surgery (e.g., anticonvulsants, aminoglycoside antibiotics, magnesium salts \[Mg2+\]) except for supplements to maintain physiological levels. 13. Participants with suspected alcohol or drug abuse; 14. Participation in strenuous activity (e.g., heavy lifting, strenuous running, competitive sports such as basketball, football, and singles tennis, mountain climbing, rowing machine training, etc) within 48 hours prior to dosing (Day 1). 15. Anatomical deformities on upper extremities that cannot perform monitoring mentioned in the protocol: non-invasive blood pressure monitor, ECG, pulse oximetry, end-tidal capnography and neuromuscular monitoring. 16. Participants who participated in other clinical trials within 3 months before the administration. 17. Female participants who are pregnant or breastfeeding, who have a positive serum or urine pregnancy test result, or who are unable or unwilling to take contraceptive or abstinence measures approved by the investigator during the study. 18. Participants who are considered not suitable for participating in a clinical trial by the investigator or the surgeon.

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As listed by the trial registrant

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How to take part

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  1. The official record

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  2. A doctor treating you

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