A Study to Evaluate the Safety and Tolerability of Multiple Dose of IBI3002 in Healthy and Asthmatic Participants
NCT ID: NCT06947408
Last Updated: 2025-05-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
60 participants
INTERVENTIONAL
2025-05-14
2026-04-23
Brief Summary
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1. Part A: 40 healthy participants will be enrolled across 5 cohorts, including dose levels of 150mg, 300mg, 600mg, 900mg SC, and 600mg IV. 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.
2. Part B: 20 patients with asthma will be enrolled across 2 cohorts, including dose levels of 300mg and 900mg SC. 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Part B IBI3002 900mg SC
Patients with asthma will receive IBI3002 900mg SC at Week 0, 2, 4, 6, 8 and 10
IBI3002
Healthy participants and patients with asthma will receive IBI3002 at the corresponding dose and dosing interval.
Part B Placebo
Patients with asthma will receive matched placebo
Placebo
Healthy participants and patients with asthma will receive matched placebo.
Part A IBI3002 300mg SC
Healthy Participants will receive IBI3002 300mg SC at Week 0, 2, 4, and 6
IBI3002
Healthy participants and patients with asthma will receive IBI3002 at the corresponding dose and dosing interval.
Part A IBI3002 600mg SC
Healthy Participants will receive IBI3002 600mg SC at Week 0, 2, 4, and 6
IBI3002
Healthy participants and patients with asthma will receive IBI3002 at the corresponding dose and dosing interval.
Part B IBI3002 300mg SC
Patients with asthma will receive IBI3002 300mg SC at Week 0, 2, 4, 6, 8 and 10
IBI3002
Healthy participants and patients with asthma will receive IBI3002 at the corresponding dose and dosing interval.
Part A Placebo
Healthy Participants will receive matched placebo
Placebo
Healthy participants and patients with asthma will receive matched placebo.
Part A IBI3002 600mg IV
Healthy Participants will receive IBI3002 600mg IV at Week 0, 2, 4, and 6
IBI3002
Healthy participants and patients with asthma will receive IBI3002 at the corresponding dose and dosing interval.
Part A IBI3002 900mg SC
Healthy Participants will receive IBI3002 900mg SC at Week 0, 2, 4, and 6
IBI3002
Healthy participants and patients with asthma will receive IBI3002 at the corresponding dose and dosing interval.
Part A IBI3002 150 mg SC
Healthy Participants will receive IBI3002 150mg SC at Week 0, 4 and 8
IBI3002
Healthy participants and patients with asthma will receive IBI3002 at the corresponding dose and dosing interval.
Interventions
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Placebo
Healthy participants and patients with asthma will receive matched placebo.
IBI3002
Healthy participants and patients with asthma will receive IBI3002 at the corresponding dose and dosing interval.
Eligibility Criteria
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Inclusion Criteria
2. (Part B) Diagnosed with asthma for at least 12 months according to the Global Initiative for Asthma (GINA) and confirmed by the Investigator.
3. (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.
4. (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.
5. (Part B) Pre-BD FEV1 ≤ 80% of prediction.
Exclusion Criteria
2. (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.
3. (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.
4. (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.
5. (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.
18 Years
65 Years
ALL
Yes
Sponsors
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Innovent Biologics (Suzhou) Co. Ltd.
INDUSTRY
Responsible Party
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Locations
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China-japan Friendship Hosipital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CIBI3002A102
Identifier Type: -
Identifier Source: org_study_id
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