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First human test of CM583: can this biologic pass the safety check?

NCT ID NCT07823764

Knowledge-focused Sponsor: Keymed Biosciences Co.Ltd Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time

Summary

Researchers are running a Phase 1 trial of CM583, an experimental biologic, in about 40 healthy adults aged 18 to 45. Participants receive a single injection under the skin of either CM583 or a placebo, with five increasing dose levels tested. The study tracks side effects, vital signs, heart rhythm, lab results, and how the body processes the drug to see whether it is safe and well tolerated.

What this could mean

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

Active substance
CM583, an experimental biologic given as a single injection under the skin
What this could lead to
If CM583 proves safe and behaves predictably in the body, researchers could move it into later-stage trials for the disease it is designed to treat.
What could go wrong
This is a first-in-human Phase 1 study in 40 healthy volunteers, so it can only show early safety signals, not whether the drug works. Many experimental biologics fail later, and injection reactions or immune responses are possible.

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 40 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Jul 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 45 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: * Subjects age ≥ 18 years \& ≤45 years. * Subjects voluntarily signed the Informed Consent Form and were able to comply with the provisions of this protocol. Exclusion Criteria: * The average number of cigarettes smoked per day is greater than 5 within 3 months prior to screening. * Drinking heavily within 3 months prior to screening, or unable to guarantee not to drink alcohol during the research period, or positive alcohol breath testing. * History of drug abuse within 1 year prior to screening, or positive urine drug abuse screening. * Blood donation or any other form of blood loss exceeding 400mL, or accepting blood transfusion within 12 weeks prior to screening. * Suspected allergy to CGRP(Calcitonin Gene-Related Peptide)- or PACAP(Pituitary Adenylate Cyclase-Activating Polypeptide)-targeting antibody drugs, humanized monoclonal antibody drugs and their excipients, or other biological agents, or have a history of severe allergic reactions to other drugs. * Severe trauma or undergo major surgery within 3 months prior to screening, or planned surgery during the research period.

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As listed by the trial registrant

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

Healthy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. 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.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • The Second Affiliated Hospital Zhejiang University School of Medcine

    Hangzhou, Zhejiang, China

    Contact Email: •••••@•••••

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