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New drug QLS7305 tested in healthy volunteers – first step for future therapies

NCT ID NCT07313150

Knowledge-focused Sponsor: Qilu Pharmaceutical 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 1 trial will test the safety and tolerability of QLS7305, an investigational drug, in 60 healthy Chinese adults. Participants will receive either single or multiple doses of the drug or a placebo, along with preventive antibiotics. The study focuses on how the body processes the drug and its effects on the immune system, with no direct treatment benefit for volunteers.

What this could mean

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

Active substance
QLS7305 injection
What could go wrong
This is a very early Phase 1 study in healthy volunteers, so it is not designed to test any treatment effect. The drug may prove unsafe or ineffective in future patient studies.

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 60 people

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

Expected to start

Jan 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 55 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: Aged between 18 and 55 years (inclusive) Physical examination, vital signs, laboratory tests, 12-lead ECG, and imaging findings are within normal ranges. Body weight ≥50 kg for males and ≥45 kg for females, with a BM) between 18.0 and 28 kg/m² (inclusive). Willing or has complied with the administration of meningococcal and pneumococcal vaccines as required by the protocol. No plan to donate sperm or ova, no pregnancy plan, and voluntarily agrees to use effective contraception methods from the signing of the ICF until 12 months after administration of the investigational product. Able to understand and comply with the study procedures, voluntarily participate in the trial, and provide written informed consent. Exclusion Criteria: History of food or drug allergy, and/or known allergy to GalNAc. History of definite infection with encapsulated bacteria within 6 months prior to screening. History of recurrent or chronic infection within 3 months prior to screening. Presence or suspicion of active viral, bacterial, fungal, or parasitic infection within 1 month prior to baseline. Any disease at screening that, in the investigator's judgment, could affect the study data. History of malignancy. Any condition that may affect drug absorption. History of splenectomy or congenital asplenia. History of congenital or acquired complement deficiency or disorder. History of allergic diseases (e.g., allergic asthma, allergic rhinitis).

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As listed by the trial registrant

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

Healthy volunteers - male and female

How to take part

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  1. 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 ↗

  2. A doctor treating you

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