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

Innovent Biologics

Status and phase: Enrolling; Phase 1

Conditions: Asthma

Treatments: Drug: Placebo; Drug: IBI3002

Study type: Interventional

Funder types: Industry

Identifiers

NCT06947408

CIBI3002A102

Details and patient eligibility

About

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 dose levels of 150mg, 300mg, 600mg, 900mg SC, and 600mg IV. 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, including dose levels of 300mg and 900mg SC. 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 9 patient groups, including a placebo group

Part B IBI3002 900mg SC

Experimental group

Description:

Patients with asthma will receive IBI3002 900mg SC at Week 0, 2, 4, 6, 8 and 10

Treatment:

Drug: IBI3002

Part B Placebo

Placebo Comparator group

Description:

Patients with asthma will receive matched placebo

Treatment:

Drug: Placebo

Part A IBI3002 300mg SC

Experimental group

Description:

Healthy Participants will receive IBI3002 300mg SC at Week 0, 2, 4, and 6

Treatment:

Drug: IBI3002

Part A IBI3002 600mg SC

Experimental group

Description:

Healthy Participants will receive IBI3002 600mg SC at Week 0, 2, 4, and 6

Treatment:

Drug: IBI3002

Part B IBI3002 300mg SC

Experimental group

Description:

Patients with asthma will receive IBI3002 300mg SC at Week 0, 2, 4, 6, 8 and 10

Treatment:

Drug: IBI3002

Part A Placebo

Placebo Comparator group

Description:

Healthy Participants will receive matched placebo

Treatment:

Drug: Placebo

Part A IBI3002 600mg IV

Experimental group

Description:

Healthy Participants will receive IBI3002 600mg IV at Week 0, 2, 4, and 6

Treatment:

Drug: IBI3002

Part A IBI3002 900mg SC

Experimental group

Description:

Healthy Participants will receive IBI3002 900mg SC at Week 0, 2, 4, and 6

Treatment:

Drug: IBI3002

Part A IBI3002 150 mg SC

Experimental group

Description:

Healthy Participants will receive IBI3002 150mg SC at Week 0, 4 and 8

Treatment:

Drug: IBI3002