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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Single dose of Placebo administered subcutaneously on Day 1 |
|
| IBI3002 | Experimental | Single dose of IBI3002 (Dosage 1, Dosage 2, Dosage 3, Dosage 4, Dosage 5, Dosage 6) administered subcutaneously on Day 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI3002 | Drug | Single dose of IBI3002 (Dosage 1, Dosage 2, Dosage 3, Dosage 4, Dosage 5, Dosage 6), administered subcutaneously on Day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with AEs/SAEs | Incidence of adverse events and severe adverse events | Baseline up to Day 36 |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameter: Cmax | Observed maximum plasma concentration | Baseline up to Day 36 |
| PK parameter: tmax | Time to achieve Cmax | Baseline up to Day 36 |
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Inclusion Criteria:
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:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nucleus Network Pty Ltd | Melbourne | Victoria | 3004 | Australia |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D012847 | Single Person |
| ID | Term |
|---|---|
| D017533 | Marital Status |
| D005191 | Family Characteristics |
| D003710 | Demography |
| D011154 | Population Characteristics |
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| Placebo | Drug | Single dose of Placebo, administered subcutaneously on Day 1 |
|
|
| PK parameter: AUC | Area under the plasma concentration-time curve | Baseline up to Day 36 |
| Immunogenicity profiles | Frequency and titers of anti-drug antibody (ADA) | Baseline up to Day 36 |
| PD profile (only in asthmatics): TARC (CCL17) | Change from baseline in peripheral blood TARC (CCL17) level | Baseline up to Day 36 |
| PD profile (only in asthmatics): IL-13 | Change from baseline in peripheral blood IL-13 level | Baseline up to Day 36 |
| PD profile (only in asthmatics): IgE | Change from baseline in peripheral blood Immunoglobulin | Baseline up to Day 36 |
| PD profile (only in asthmatics): Eosinophil | Change from baseline in peripheral blood eosinophil level | Baseline up to Day 36 |
| Clinical profile (only in asthmatics): FeNO | Change from baseline in Fractional exhaled Nitric Oxide | Baseline up to Day 36 |
| Clinical profile (only in asthmatics): Spirometry | Change from baseline in pre-bronchodilator forced expiratory volume in 1 second (Pre-BD FEV1) | Baseline up to Day 36 |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012959 |
| Socioeconomic Factors |