A First-in-human, Single-ascending-dose Study of IBI3002 in Healthy Participants and Mild to Moderate Asthmatics

Asthma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06213844
• Other study ID #: CIBI3002A101AU
• Status: Recruiting
• Phase: Phase 1
• Start date: February 26, 2024
• Est. completion date: February 15, 2025

Study information

• Verified date: March 2024
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: Sam Francis
• Phone: 0385939801
• Email: s.francis[@]nucleusnetwork.com.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: February 15, 2025
• Est. primary completion date: February 15, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Healthy Participants

Intervention

Drug:
• IBI3002
Single dose of IBI3002 (Dosage 1, Dosage 2, Dosage 3, Dosage 4, Dosage 5, Dosage 6), administered subcutaneously on Day 1
• Placebo
Single dose of Placebo, administered subcutaneously on Day 1

Locations

Country	Name	City	State
Australia	Nucleus Network Pty Ltd	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with AEs/SAEs	Incidence of adverse events and severe adverse events	Baseline up to Day 36
Secondary	PK parameter: Cmax	Observed maximum plasma concentration	Baseline up to Day 36
Secondary	PK parameter: tmax	Time to achieve Cmax	Baseline up to Day 36
Secondary	PK parameter: AUC	Area under the plasma concentration-time curve	Baseline up to Day 36
Secondary	Immunogenicity profiles	Frequency and titers of anti-drug antibody (ADA)	Baseline up to Day 36
Secondary	PD profile (only in asthmatics): TARC (CCL17)	Change from baseline in peripheral blood TARC (CCL17) level	Baseline up to Day 36
Secondary	PD profile (only in asthmatics): IL-13	Change from baseline in peripheral blood IL-13 level	Baseline up to Day 36
Secondary	PD profile (only in asthmatics): IgE	Change from baseline in peripheral blood Immunoglobulin	Baseline up to Day 36
Secondary	PD profile (only in asthmatics): Eosinophil	Change from baseline in peripheral blood eosinophil level	Baseline up to Day 36
Secondary	Clinical profile (only in asthmatics): FeNO	Change from baseline in Fractional exhaled Nitric Oxide	Baseline up to Day 36
Secondary	Clinical profile (only in asthmatics): Spirometry	Change from baseline in pre-bronchodilator forced expiratory volume in 1 second (Pre-BD FEV1)	Baseline up to Day 36