Clinical trial NCT06213844: A First-in-human, Single-ascending-dose Study of IBI3002 in Healthy Participants and Mild to Moderate Asthmatics
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Participants
Asthma
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2024-01-19
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of participants with AEs/SAEs
timeFrame: Baseline up to Day 36
Secondary outcomes:
measure: PK parameter: Cmax
timeFrame: Baseline up to Day 36
measure: PK parameter: tmax
timeFrame: Baseline up to Day 36
measure: PK parameter: AUC
timeFrame: Baseline up to Day 36
measure: Immunogenicity profiles
timeFrame: Baseline up to Day 36
measure: PD profile (only in asthmatics): TARC (CCL17)
timeFrame: Baseline up to Day 36
measure: PD profile (only in asthmatics): IL-13
timeFrame: Baseline up to Day 36
measure: PD profile (only in asthmatics): IgE
timeFrame: Baseline up to Day 36
measure: PD profile (only in asthmatics): Eosinophil
timeFrame: Baseline up to Day 36
measure: Clinical profile (only in asthmatics): FeNO
timeFrame: Baseline up to Day 36
measure: Clinical profile (only in asthmatics): Spirometry
timeFrame: Baseline up to Day 36
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Nucleus Network Pty Ltd
state: Victoria
Study officials:
References: