AsthmaPhase 1NCT06947408
A Study to Evaluate the Safety and Tolerability of Multiple Dose of IBI3002 in Healthy and Asthmatic Participants
A Phase 1 study testing IBI3002 in people with Asthma, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
This study is a randomized, double-blind, placebo-controlled multiple dose ascending study in healthy participants and patients with asthma. Healthy participants will be enrolled in Part A and patients with asthma in Part B: 1. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- 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
- 44 participants
- Where
- 1 siteChina
- Study dates
- 14 May 2025to 11 May 2026
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- (Part A and B) The body weight of men ≥ 50kg, and of women ≥ 45kg; Body mass index (BMI) between 18 and 32 kg/m2 (including cut-off values).
- (Part B) Diagnosed with asthma for at least 12 months according to the Global Initiative for Asthma (GINA) and confirmed by the Investigator.
- (Part B) Evidence of airway reversibility within 5 years prior to screening, including but not limited to a positive bronchodilation test or bronchoprovocation test. If the historical results are not available, tests during the screening period will also be accepted.
- (Part B) Medium-high dose ICS therapy (defined as a daily dose of ≥250μg fluticasone propionate or equivalent ICS dose) in combination with at least one second controller [e.g., LABA, LAMA, or LTRA for at least 3 months with a stable dose for at least 1 month prior to randomization.
- (Part B) Pre-BD FEV1 ≤ 80% of prediction.
Who cannot join
- (Part A and B) Diseases that have an impact on the participant's own safety or participation in the study as judged by the investigator. This includes, but not limited to, mental disorders, diseases of the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, or metabolic system.
- (Part A and B) Participants with known history of active tuberculosis or clinical suspicion of tuberculosis (including but not limited to pulmonary tuberculosis, lymph node tuberculosis, tuberculous pleurisy, etc.); or positive T-SPOT.TB during the screening period, or evidence of suspected tuberculosis on chest imaging, or any other clinical evidence of latent tuberculosis.
- (Part A and B) A history of malignancy, except for localized basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) of the skin that has been resected or cured.
- (Part B) History of a life-threatening asthma attack requiring mechanical ventilation, and/or an asthma attack related to hypercapnia, respiratory failure, or hypoxic epilepsy within 5 years prior to screening.
- (Part B) History of an asthma worsening or exacerbation that resulted in an visit to emergency room or hospitalization, or an increase in asthma controller, or requiring any systemic glucocorticoid therapy within 3 months prior to screening.
- The above information is not intended to contain all considerations relevant to a participant's potential participation in this trial.
Trial locations and contacts
1 site in 1 country.
China1 site
China-japan Friendship Hosipital
Beijing, Beijing Municipality, 100192
About this study
Official title: A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of IBI3002 Multiple Dosing in Healthy Participants and Patients With Asthma - A Randomized, Double-Blind, Placebo-Controlled, Dose-Ascending Study
This study is a randomized, double-blind, placebo-controlled multiple dose ascending study in healthy participants and patients with asthma. Healthy participants will be enrolled in Part A and patients with asthma in Part B:
- Part A: 40 healthy participants will be enrolled across 5 cohorts, including 5 different dose levels. In each cohort, there will be 8 participants randomized at a ratio of 6:2 to receive IBI3002 or matched placebo. The study consists of a screening period, a double-blind treatment period and a safety follow-up period. The study has a total duration of approximately 12 to 14 weeks.
- Part B: 20 patients with asthma will be enrolled across 2 cohorts. In each cohort, there will be 10 participants randomized at a ratio of 8:2 to receive IBI3002 or matched placebo. The study consists of a screening period, a double-blind treatment period and a safety follow-up period. The study has a total duration of approximately 16 weeks.
- Conditions
- Asthma
- Being tested
- Placebo, IBI3002
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Healthy participants and patients with asthma will receive matched placebo.
IBI3002Drug
Healthy participants and patients with asthma will receive IBI3002 at the corresponding dose and dosing interval.
| Study group | Role | What they receive |
|---|---|---|
| Part B IBI3002 dose 5 SC | Experimental | Patients with asthma will receive IBI3002 dose 5 SC at Week 0, 2, 4, 6, 8 and 10 Receives: Drug: IBI3002 |
| Part B Placebo | Placebo comparator | Patients with asthma will receive matched placebo Receives: Drug: Placebo |
| Part A IBI3002 dose2 SC | Experimental | Healthy Participants will receive IBI3002 dose 2 SC at Week 0, 2, 4, and 6 Receives: Drug: IBI3002 |
| Part A IBI3002 dose 4 SC | Experimental | Healthy Participants will receive IBI3002 dose 4 SC at Week 0, 2, 4, and 6 Receives: Drug: IBI3002 |
| Part B IBI3002 dose 2 SC | Experimental | Patients with asthma will receive IBI3002 dose 2 SC at Week 0, 2, 4, 6, 8 and 10 Receives: Drug: IBI3002 |
| Part A Placebo | Placebo comparator | Healthy Participants will receive matched placebo Receives: Drug: Placebo |
| Part A IBI3002 dose 3 IV | Experimental | Healthy Participants will receive IBI3002 dose 3 IV at Week 0, 2, 4, and 6 Receives: Drug: IBI3002 |
| Part A IBI3002 dose 5 SC | Experimental | Healthy Participants will receive IBI3002 dose 5 SC at Week 0, 2, 4, and 6 Receives: Drug: IBI3002 |
| Part A IBI3002 dose1 SC | Experimental | Healthy Participants will receive IBI3002 dose1 SC at Week 0, 4 and 8 Receives: Drug: IBI3002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the Incidence of sudden adverse events of healthy participants and patients with asthma receiving IBI3002 multiple ascending doses.
Incidence of adverse events (AEs) and serious adverse events (SAEs) after IBI3002 multiple doses in healthy participants;
Measured: baseline to Week16
Secondary outcomes (5)
To assess PK parameters of healthy participants and patients with asthma receiving IBI3002 multiple ascending doses.
PK parameters include, the maximum concentration (Cmax), after multiple doses.
Measured: baseline to Week16
To assess PK parameters of healthy participants and patients with asthma receiving IBI3002 multiple ascending doses.
PK parameters include, the time to achieve Cmax (Tmax), after multiple doses.
Measured: baseline to Week16
To assess PK parameters of healthy participants and patients with asthma receiving IBI3002 multiple ascending doses.
PK parameters include, the area under the concentration-time curve (AUC) ,after multiple doses.
Measured: baseline to Week16
To assess PK parameters of healthy participants and patients with asthma receiving IBI3002 multiple ascending doses.
PK parameters include the trough concentration (Cmin) after multiple doses.
Measured: baseline to Week16
To assess the incidence of immunogenicity of healthy participants and patients with asthma receiving IBI3002 multiple ascending doses.
the incidence of immunogenicity of IBI3002.
Measured: baseline to Week16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start14 May 2025
- Primary completion11 May 2026
- Study completion11 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Innovent Biologics (Suzhou) Co. Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06947408
- Sponsor's protocol ID
- CIBI3002A102
- Status last verified
- Jun 2026
- First submitted
- 10 Apr 2025
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of IBI3002 Multiple Dosing in Healthy Participants and Patients With Asthma - A Randomized, Double-Blind, Placebo-Controlled, Dose-Ascending Study
- ClinicalTrials.gov ID
- NCT06947408
- Acronym / sponsor ID
- CIBI3002A102
- Conditions
- Asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 May 2025 (actual)
- Primary completion
- 11 May 2026 (actual)
- Study completion
- 11 May 2026 (actual)
- First posted
- 27 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a randomized, double-blind, placebo-controlled multiple dose ascending study in healthy participants and patients with asthma. Healthy participants will be enrolled in Part A and patients with asthma in Part B:
- Part A: 40 healthy participants will be enrolled across 5 cohorts, including 5 different dose levels. In each cohort, there will be 8 participants randomized at a ratio of 6:2 to receive IBI3002 or matched placebo. The study consists of a screening period, a double-blind treatment period and a safety follow-up period. The study has a total duration of approximately 12 to 14 weeks.
- Part B: 20 patients with asthma will be enrolled across 2 cohorts. In each cohort, there will be 10 participants randomized at a ratio of 8:2 to receive IBI3002 or matched placebo. The study consists of a screening period, a double-blind treatment period and a safety follow-up period. The study has a total duration of approximately 16 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Part B IBI3002 dose 5 SC | Experimental | Drug: IBI3002Patients with asthma will receive IBI3002 dose 5 SC at Week 0, 2, 4, 6, 8 and 10 |
| Part B Placebo | Placebo comparator | Drug: PlaceboPatients with asthma will receive matched placebo |
| Part A IBI3002 dose2 SC | Experimental | Drug: IBI3002Healthy Participants will receive IBI3002 dose 2 SC at Week 0, 2, 4, and 6 |
| Part A IBI3002 dose 4 SC | Experimental | Drug: IBI3002Healthy Participants will receive IBI3002 dose 4 SC at Week 0, 2, 4, and 6 |
| Part B IBI3002 dose 2 SC | Experimental | Drug: IBI3002Patients with asthma will receive IBI3002 dose 2 SC at Week 0, 2, 4, 6, 8 and 10 |
| Part A Placebo | Placebo comparator | Drug: PlaceboHealthy Participants will receive matched placebo |
| Part A IBI3002 dose 3 IV | Experimental | Drug: IBI3002Healthy Participants will receive IBI3002 dose 3 IV at Week 0, 2, 4, and 6 |
| Part A IBI3002 dose 5 SC | Experimental | Drug: IBI3002Healthy Participants will receive IBI3002 dose 5 SC at Week 0, 2, 4, and 6 |
| Part A IBI3002 dose1 SC | Experimental | Drug: IBI3002Healthy Participants will receive IBI3002 dose1 SC at Week 0, 4 and 8 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- (Part A and B) The body weight of men ≥ 50kg, and of women ≥ 45kg; Body mass index (BMI) between 18 and 32 kg/m2 (including cut-off values).
- (Part B) Diagnosed with asthma for at least 12 months according to the Global Initiative for Asthma (GINA) and confirmed by the Investigator.
- (Part B) Evidence of airway reversibility within 5 years prior to screening, including but not limited to a positive bronchodilation test or bronchoprovocation test. If the historical results are not available, tests during the screening period will also be accepted.
- (Part B) Medium-high dose ICS therapy (defined as a daily dose of ≥250μg fluticasone propionate or equivalent ICS dose) in combination with at least one second controller [e.g., LABA, LAMA, or LTRA for at least 3 months with a stable dose for at least 1 month prior to randomization.
- (Part B) Pre-BD FEV1 ≤ 80% of prediction.
Key exclusion criteria (6 listed)
- (Part A and B) Diseases that have an impact on the participant's own safety or participation in the study as judged by the investigator. This includes, but not limited to, mental disorders, diseases of the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, or metabolic system.
- (Part A and B) Participants with known history of active tuberculosis or clinical suspicion of tuberculosis (including but not limited to pulmonary tuberculosis, lymph node tuberculosis, tuberculous pleurisy, etc.); or positive T-SPOT.TB during the screening period, or evidence of suspected tuberculosis on chest imaging, or any other clinical evidence of latent tuberculosis.
- (Part A and B) A history of malignancy, except for localized basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) of the skin that has been resected or cured.
- (Part B) History of a life-threatening asthma attack requiring mechanical ventilation, and/or an asthma attack related to hypercapnia, respiratory failure, or hypoxic epilepsy within 5 years prior to screening.
- (Part B) History of an asthma worsening or exacerbation that resulted in an visit to emergency room or hospitalization, or an increase in asthma controller, or requiring any systemic glucocorticoid therapy within 3 months prior to screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboHealthy participants and patients with asthma will receive matched placebo. | Drug | Part A Placebo, Part B Placebo |
| IBI3002Healthy participants and patients with asthma will receive IBI3002 at the corresponding dose and dosing interval. | Drug | Part A IBI3002 dose 3 IV, Part A IBI3002 dose 4 SC, Part A IBI3002 dose 5 SC, Part A IBI3002 dose1 SC, Part A IBI3002 dose2 SC, Part B IBI3002 dose 2 SC, Part B IBI3002 dose 5 SC |
Primary outcome
To evaluate the Incidence of sudden adverse events of healthy participants and patients with asthma receiving IBI3002 multiple ascending doses.
Time frame: baseline to Week16
Incidence of adverse events (AEs) and serious adverse events (SAEs) after IBI3002 multiple doses in healthy participants;
5 secondary outcomes
To assess PK parameters of healthy participants and patients with asthma receiving IBI3002 multiple ascending doses.
Time frame: baseline to Week16
To assess PK parameters of healthy participants and patients with asthma receiving IBI3002 multiple ascending doses.
Time frame: baseline to Week16
To assess PK parameters of healthy participants and patients with asthma receiving IBI3002 multiple ascending doses.
Time frame: baseline to Week16
To assess PK parameters of healthy participants and patients with asthma receiving IBI3002 multiple ascending doses.
Time frame: baseline to Week16
To assess the incidence of immunogenicity of healthy participants and patients with asthma receiving IBI3002 multiple ascending doses.
Time frame: baseline to Week16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
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Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IBI3002 in people with Asthma, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
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 5 inclusion and 6 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 9 Jun 2026. 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 China. 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?
To evaluate the Incidence of sudden adverse events of healthy participants and patients with asthma receiving IBI3002 multiple ascending doses. (time frame: baseline to Week16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jun 2026.