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Healthy ParticipantsPhase 1NCT06213844

A First-in-human, Single-ascending-dose Study of IBI3002 in Healthy Participants and Mild to Moderate Asthmatics

A Phase 1 study testing IBI3002 in people with Healthy Participants and Asthma, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a single-center, randomized, double-blind, placebo-controlled, phase 1, single-ascending-dose study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of IBI3002 in healthy participants and mild to moderate asthmatics. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Participants, Asthma
What is being tested?
IBI3002
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
52 participants
Where
1 siteAustralia
Study dates
26 Feb 2024to 11 Sep 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Participants must sign an Institutional Review Board (IRB) approved informed consent form before any study specific procedures.
  • Participants must be between 18 and 55 years old, inclusive.
  • Participants must have a body mass index (BMI) between 18 to 32 kg/m2, inclusive.
  • 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.
  • Participants with asthma must have:
  • Documented physician diagnosis of asthma for at least 12 months prior to screening and confirmed by the investigator;
Show all 9Show fewer
  • 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%.

Who cannot join

  • History of allergies to any components of IBI3002 or placebo.
  • History of blood or needle sickness, or those who cannot tolerate venipuncture.
  • Female participants who are pregnant or breastfeeding at screening or randomization.
  • 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.
  • 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.
  • History of live or attenuated vaccination within 1 month prior to randomization, or those who plan to be vaccinated during the study.
  • 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.
  • 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.

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Nucleus Network Pty Ltd

    Melbourne, Victoria, 3004

Other trials in Australia

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IBI3002 in Healthy Participants and Participants With Mild to Moderate Asthma

This is a single-center, randomized, double-blind, placebo-controlled, phase 1, single-ascending-dose study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of IBI3002 in healthy participants and mild to moderate asthmatics. Subjects will be randomly assigned to different dosages of IBI3002 and matched placebo groups. The entire trial cycle includes a 4-week screening period, 1-day treatment period and 5-week follow-up period.

Being tested
IBI3002, Placebo
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IBI3002Drug

    Also called ICS, alone or in combination with LABA

    Single dose of IBI3002 (Dosage 1, Dosage 2, Dosage 3, Dosage 4, Dosage 5, Dosage 6), administered subcutaneously on Day 1

  • PlaceboDrug

    Also called ICS, alone or in combination with LABA

    Single dose of Placebo, administered subcutaneously on Day 1

Study groups in NCT06213844
Study groupRoleWhat they receive
PlaceboPlacebo comparatorSingle dose of Placebo administered subcutaneously on Day 1
Receives: Drug: Placebo
IBI3002ExperimentalSingle dose of IBI3002 (Dosage 1, Dosage 2, Dosage 3, Dosage 4, Dosage 5, Dosage 6) administered subcutaneously on Day 1
Receives: Drug: IBI3002

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with AEs/SAEs

    Incidence of adverse events and severe adverse events

    Measured: Baseline up to Day 36

Secondary outcomes (10)

  1. PK parameter: Cmax

    Observed maximum plasma concentration

    Measured: Baseline up to Day 36

  2. PK parameter: tmax

    Time to achieve Cmax

    Measured: Baseline up to Day 36

  3. PK parameter: AUC

    Area under the plasma concentration-time curve

    Measured: Baseline up to Day 36

  4. Immunogenicity profiles

    Frequency and titers of anti-drug antibody (ADA)

    Measured: Baseline up to Day 36

  5. PD profile (only in asthmatics): TARC (CCL17)

    Change from baseline in peripheral blood TARC (CCL17) level

    Measured: Baseline up to Day 36

  6. PD profile (only in asthmatics): IL-13

    Change from baseline in peripheral blood IL-13 level

    Measured: Baseline up to Day 36

  7. PD profile (only in asthmatics): IgE

    Change from baseline in peripheral blood Immunoglobulin

    Measured: Baseline up to Day 36

  8. PD profile (only in asthmatics): Eosinophil

    Change from baseline in peripheral blood eosinophil level

    Measured: Baseline up to Day 36

  9. Clinical profile (only in asthmatics): FeNO

    Change from baseline in Fractional exhaled Nitric Oxide

    Measured: Baseline up to Day 36

  10. Clinical profile (only in asthmatics): Spirometry

    Change from baseline in pre-bronchodilator forced expiratory volume in 1 second (Pre-BD FEV1)

    Measured: Baseline up to Day 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2024
  2. Study start26 Feb 2024
  3. Primary completion22 Jul 2025
  4. Study completion11 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06213844
Sponsor's protocol ID
CIBI3002A101AU
Status last verified
Nov 2025
First submitted
10 Jan 2024
Last updated
21 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IBI3002 in people with Healthy Participants and Asthma, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with AEs/SAEs (time frame: Baseline up to Day 36). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06213844.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.

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