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New asthma drug IBI3002 tested in first human trial

NCT ID NCT06213844

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tested a single dose of the experimental drug IBI3002 in 52 healthy volunteers and people with mild to moderate asthma. The main goal was to check safety and how the body processes the drug. Researchers monitored side effects and drug levels in the blood over five weeks.

What this could mean

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

Active substance
IBI3002
What this could lead to
If successful, this could point toward a new treatment option for asthma that helps control symptoms.
What could go wrong
This is a very early Phase 1 trial with only 52 participants, focused on safety, not effectiveness. The drug may not work or could have side effects.

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

52 people

The number who actually took part.

Started

Feb 2024

Finished

Sep 2025

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: 1. Participants must sign an Institutional Review Board (IRB) approved informed consent form before any study specific procedures. 2. Participants must be between 18 and 55 years old, inclusive. 3. Participants must have a body mass index (BMI) between 18 to 32 kg/m2, inclusive. 4. Participants of childbearing potential and their partners should use highly effective methods of birth control during the study and until 6 months after the study. 5. Participants with asthma must have: * Documented physician diagnosis of asthma for at least 12 months prior to screening and confirmed by the investigator; * Elevated FeNO defined as ≥ 25ppb; * Documented and stable GINA 2023 recommended Step 1\~3 controller treatment (defined as ≤ 250μg fluticasone propionate dry powder formulation equivalent total daily dose of ICS, alone or in combination with LABA) for the last 3 months prior to screening; * Pre-BD FEV1 ≥ 60% of prediction and Post-BD FEV1/forced vital capacity (FVC) \> 70%. Exclusion Criteria: 1. History of allergies to any components of IBI3002 or placebo. 2. History of blood or needle sickness, or those who cannot tolerate venipuncture. 3. Female participants who are pregnant or breastfeeding at screening or randomization. 4. History of participating in a clinical trial within 1 month or 5 half-lives of the test drug (whichever is longer) prior to randomization, or those who are currently participating in a clinical trial. 5. History of severe infection or significant injury within 6 months, or surgery within 3 months, or any infection requiring systemic medication within 1 month prior to screening or randomization. 6. History of live or attenuated vaccination within 1 month prior to randomization, or those who plan to be vaccinated during the study. 7. For asthmatics only: history of a life-threatening asthma attack that required mechanical ventilation and/or was associated with hypercapnia, respiratory arrest or hypoxic seizures within the last 5 years prior to randomization. 8. For asthmatics only: history of asthma worsen or exacerbation resulting in emergency room (ER) visits or overnight hospitalizations, or an increase in asthma maintenance therapy, or use of systemic glucocorticoids within the last 3 months prior to randomization.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Nucleus Network Pty Ltd

    Melbourne, Victoria, 3004, Australia

More trials for these conditions

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