Testing IBI3002 in healthy people and those with mild to moderate asthma

A Randomized, Double-Blind, Placebo-Controlled Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IBI3002 in Healthy Participants and Participants With Mild to Moderate Asthma

This study is testing a new treatment called IBI3002 to see if it's safe and how it works in healthy people and those with mild to moderate asthma.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 52 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. (industry)
• Locations: 1 site (Melbourne, Victoria)
• Trial ID: NCT06213844 on ClinicalTrials.gov

What this trial studies

This is a first-in-human, single-ascending-dose study designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of IBI3002. The study will involve healthy participants and individuals with mild to moderate asthma, who will be randomly assigned to receive varying doses of IBI3002 or a placebo. The trial includes a 4-week screening period, a 1-day treatment period, and a 5-week follow-up period to monitor outcomes.

Who should consider this trial

Good fit: Ideal candidates include healthy adults aged 18 to 55 and individuals with mild to moderate asthma who meet specific inclusion criteria.

Not a fit: Patients with severe asthma or those outside the age range of 18 to 55 may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to new treatment options for asthma patients.

How similar studies have performed: Other studies have shown promise with similar approaches in evaluating new asthma treatments, but this specific intervention is novel.

Eligibility criteria

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.

Where this trial is running

Melbourne, Victoria

• Nucleus Network Pty Ltd — Melbourne, Victoria, Australia (RECRUITING)

Study contacts

• Study coordinator: Sam Francis

Conditions: Healthy Participants, Asthma