New manufacturing site for RAY1225 put to the test

NCT ID NCT07827027

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 18, 2026 · Last updated Sep 18, 2026

Summary

Researchers are running a Phase 1 study to compare how the body handles RAY1225 injection made at a new site or batch versus the earlier version. Sixty-eight healthy volunteers receive a single 3 mg dose under the skin. The team measures drug levels in the blood over time and tracks side effects. The goal is to confirm the updated product delivers the same drug exposure as before.

What this could mean

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

Active substance
RAY1225, an experimental injectable drug given as a single shot under the skin
What this could lead to
If the new site and batch produce the same drug levels in the body, researchers could use the updated manufacturing process in later studies of RAY1225.
What could go wrong
This is a small Phase 1 study in healthy people, so it cannot show whether RAY1225 works for any condition. The drug may cause side effects, and the results may not apply to 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 1

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

Participants

About 68 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2026

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 55 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. Signature of a dated Informed Consent Form (ICF) indicating that the subject has been informed of all the relevant aspects(including adverse events) of the trial prior to enrollment. 2. Participants must be willing and able to adhere to the visit schedule and protocol requirements and be available to complete the study. 3. Participants (including partners) must use reliable methods of contraception during the study and until 3 months following the last dose of investigational product. 4. Body weight is no less than 55 kg in males and no less than 50 kg in females. Body mass index (BMI) 22≤BMI\<28 kg/m2. Exclusion Criteria: 1. A history of medullary thyroid carcinoma (MTC) or current diagnosis of MTC, or a family history of MTC (grandparents, parents, and siblings), or a diagnosis of multiple endocrine neoplasia type 2 (MEN2); 2. A history of hypoglycemic episodes within 12 months prior to screening; 3. Major surgery or severe infection within 12 weeks prior to screening; 4. Acute illness occurring from the time of signing the informed consent form to the administration of the investigational drug; 5. Clinically significant abnormalities in physical examination, vital signs, laboratory tests (complete blood count, blood biochemistry, urinalysis, coagulation function, serum calcitonin), thyroid ultrasound, abdominal color Doppler ultrasound (liver, gallbladder, pancreas, spleen, and kidneys), or chest X-ray (posteroanterior and lateral views); 6. Positive for any of the following at screening: hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), or Treponema pallidum antibody (TP-Ab); 7. Clinically significant abnormalities on 12-lead electrocardiogram (ECG) at screening, or QTcF \> 450 ms on ECG, or a family history of long QT syndrome or Brugada syndrome; 8. Vaccination within 4 weeks prior to screening, or planned vaccination during the trial period; 9. Use of any prescription drugs, over-the-counter drugs, or traditional Chinese medicines within 4 weeks prior to screening, or planned concomitant use during the trial period.

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As listed by the trial registrant

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