Asthma
Conditions
Brief 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. 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. 2. 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.
Interventions
DRUGPlacebo
Healthy participants and patients with asthma will receive matched placebo.
DRUGIBI3002
Healthy participants and patients with asthma will receive IBI3002 at the corresponding dose and dosing interval.
Sponsors
Innovent Biologics (Suzhou) Co. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. (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). 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
1. (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. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the Incidence of sudden adverse events of healthy participants and patients with asthma receiving IBI3002 multiple ascending doses. | baseline to Week16 | Incidence of adverse events (AEs) and serious adverse events (SAEs) after IBI3002 multiple doses in healthy participants; |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To assess PK parameters of healthy participants and patients with asthma receiving IBI3002 multiple ascending doses. | baseline to Week16 | PK parameters include, the maximum concentration (Cmax), after multiple doses. |
| To assess the incidence of immunogenicity of healthy participants and patients with asthma receiving IBI3002 multiple ascending doses. | baseline to Week16 | the incidence of immunogenicity of IBI3002. |
Countries
China
Outcome results
None listed