Asthma, Healthy Participants
Conditions
Brief 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. 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.
Interventions
DRUGIBI3002
Single dose of IBI3002 (Dosage 1, Dosage 2, Dosage 3, Dosage 4, Dosage 5, Dosage 6), administered subcutaneously on Day 1
DRUGPlacebo
Single dose of Placebo, administered subcutaneously on Day 1
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 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Participants must sign an Institutional Review Board (IRB) approved informed consent form before any study specific procedures. 2. Participants must be between 18 and 55 years old, inclusive. 3. Participants must have a body mass index (BMI) between 18 to 32 kg/m2, inclusive. 4. 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. 5. Participants with asthma must have: * Documented physician diagnosis of asthma for at least 12 months prior to screening and confirmed by the investigator; * 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%.
Exclusion criteria
1. History of allergies to any components of IBI3002 or placebo. 2. History of blood or needle sickness, or those who cannot tolerate venipuncture. 3. Female participants who are pregnant or breastfeeding at screening or randomization. 4. 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. 5. 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. 6. History of live or attenuated vaccination within 1 month prior to randomization, or those who plan to be vaccinated during the study. 7. 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. 8. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with AEs/SAEs | Baseline up to Day 36 | Incidence of adverse events and severe adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PD profile (only in asthmatics): TARC (CCL17) | Baseline up to Day 36 | Change from baseline in peripheral blood TARC (CCL17) level |
| PD profile (only in asthmatics): IL-13 | Baseline up to Day 36 | Change from baseline in peripheral blood IL-13 level |
| PK parameter: Cmax | Baseline up to Day 36 | Observed maximum plasma concentration |
| PK parameter: tmax | Baseline up to Day 36 | Time to achieve Cmax |
| Immunogenicity profiles | Baseline up to Day 36 | Frequency and titers of anti-drug antibody (ADA) |
| PD profile (only in asthmatics): IgE | Baseline up to Day 36 | Change from baseline in peripheral blood Immunoglobulin |
| PD profile (only in asthmatics): Eosinophil | Baseline up to Day 36 | Change from baseline in peripheral blood eosinophil level |
| Clinical profile (only in asthmatics): FeNO | Baseline up to Day 36 | Change from baseline in Fractional exhaled Nitric Oxide |
| Clinical profile (only in asthmatics): Spirometry | Baseline up to Day 36 | Change from baseline in pre-bronchodilator forced expiratory volume in 1 second (Pre-BD FEV1) |
| PK parameter: AUC | Baseline up to Day 36 | Area under the plasma concentration-time curve |
Countries
Australia
Outcome results
None listed