New manufacturing site for RAY1225 put to the test
NCT ID NCT07827027
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 68 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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