Evaluating the safety of IBI3002 in healthy individuals and asthma patients

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 testing a new drug called IBI3002 to see if it's safe for healthy people and those with asthma.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. (Industry-sponsored)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06947408 on ClinicalTrials.gov

What this trial studies

This study is a randomized, double-blind, placebo-controlled trial designed to evaluate the safety and tolerability of multiple doses of IBI3002 in both healthy participants and patients with asthma. It consists of two parts: Part A involves 40 healthy participants receiving varying doses of IBI3002 or placebo, while Part B includes 20 asthma patients receiving specific doses of the drug. The study will monitor participants over a period of approximately 12 to 14 weeks, including a screening phase, treatment phase, and safety follow-up. The aim is to assess the drug's effects and safety profile in these populations.

Who should consider this trial

Good fit: Ideal candidates for this study are adults diagnosed with asthma who have been on medium-high dose inhaled corticosteroid therapy and meet specific lung function criteria.

Not a fit: Patients with severe asthma or those not currently on appropriate asthma management therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a new treatment option for asthma patients, improving their management and quality of life.

How similar studies have performed: While this approach is being tested in this specific context, similar studies evaluating new asthma treatments have shown promise in the past.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality

• China-japan Friendship Hosipital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Wenjing Duan

Conditions Asthma