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Healthy men test new drug to see if different factories make it the same

NCT ID NCT07043283

Knowledge-focused Sponsor: Akeso 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tested a single injection of ebronucimab in 230 healthy Chinese men to see if different production methods change how the drug behaves in the body. The main goal was to measure drug levels in the blood and check for side effects. This trial does not aim to treat any disease, but to gather information for future studies.

What this could mean

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

Active substance
Ebronucimab

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

230 people

The number who actually took part.

Started

Oct 2025

Finished

Feb 2026

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

Male participants only

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 fully understand the purpose, content, process, and potential adverse events of the trial, voluntarily participate in the trial, and sign an informed consent form before any trial procedure begins. * Weight: 60\~72kg; Body mass index (BMI) ≥ 19 and ≤ 26 kg /m² for healthy Chinese male subjects. * Fasting LDL-C level\<4.1mmol/L. * Fasting triglycerides\<3.42mmol/L. * Required to voluntarily adopt effective contraceptive measures as specified in the protocol throughout the entire trial period and within 3 months after receiving the investigational product, and avoid sperm donation. Exclusion Criteria: * 12 months prior use of PCSK9 inhibitors treatment. * Allergic to the components of Ebronucimab and any monoclonal antibodies. * History of important organ transplantation (such as heart, lung, liver, kidney, etc.). * Abnormal vital signs during screening period and before randomization. * Investigators believe that other factors may disqualify individuals from participating in the trial.

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As listed by the trial registrant

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

Healthy subjects

Contacts and locations

Locations

  • Zhejiang Xiaoshan Hospital

    Hangzhou, Zhejiang, China

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Other studies related to the condition(s) this trial covers.