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NCT Number: NCT06947408

A Study to Evaluate the Safety and Tolerability of Multiple Dose of IBI3002 in Healthy and Asthmatic Participants

This study is a randomized, double-blind, placebo-controlled multiple dose ascending study in healthy participants and patients with asthma. Healthy participants will be enrolled in Part A and patients with asthma in Part B:

1. Part A: 40 healthy participants will be enrolled across 5 cohorts, including 5 different dose levels. In each cohort, there will be 8 participants randomized at a ratio of 6:2 to receive IBI3002 or matched placebo. The study consists of a screening period, a double-blind treatment period and a safety follow-up period. The study has a total duration of approximately 12 to 14 weeks. 2. Part B: 20 patients with asthma will be enrolled across 2 cohorts. In each cohort, there will be 10 participants randomized at a ratio of 8:2 to receive IBI3002 or matched placebo. The study consists of a screening period, a double-blind treatment period and a safety follow-up period. The study has a total duration of approximately 16 weeks.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

China-japan Friendship Hosipital

Beijing, Beijing Municipality, 100192, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • (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).
  • (Part B) Diagnosed with asthma for at least 12 months according to the Global Initiative for Asthma (GINA) and confirmed by the Investigator.
  • (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.
  • (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.
  • (Part B) Pre-BD FEV1 ≤ 80% of prediction.

Exclusion criteria

  • (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.
  • (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.
  • (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.
  • (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.
  • (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.

Treatment and study plan

Placebo

Drug

Healthy participants and patients with asthma will receive matched placebo.

IBI3002

Drug

Healthy participants and patients with asthma will receive IBI3002 at the corresponding dose and dosing interval.

Primary outcomes

  1. To evaluate the Incidence of sudden adverse events of healthy participants and patients with asthma receiving IBI3002 multiple ascending doses.

    Time frame: baseline to Week16

    Incidence of adverse events (AEs) and serious adverse events (SAEs) after IBI3002 multiple doses in healthy participants;

Secondary outcomes

  1. To assess PK parameters of healthy participants and patients with asthma receiving IBI3002 multiple ascending doses.

    Time frame: baseline to Week16

    PK parameters include, the maximum concentration (Cmax), after multiple doses.

  2. To assess PK parameters of healthy participants and patients with asthma receiving IBI3002 multiple ascending doses.

    Time frame: baseline to Week16

    PK parameters include, the time to achieve Cmax (Tmax), after multiple doses.

  3. To assess PK parameters of healthy participants and patients with asthma receiving IBI3002 multiple ascending doses.

    Time frame: baseline to Week16

    PK parameters include, the area under the concentration-time curve (AUC) ,after multiple doses.

  4. To assess PK parameters of healthy participants and patients with asthma receiving IBI3002 multiple ascending doses.

    Time frame: baseline to Week16

    PK parameters include the trough concentration (Cmin) after multiple doses.

  5. To assess the incidence of immunogenicity of healthy participants and patients with asthma receiving IBI3002 multiple ascending doses.

    Time frame: baseline to Week16

    the incidence of immunogenicity of IBI3002.

Sponsors and collaborators

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 27, 2025
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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