Safety and Tolerability of IBI355 in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: placebo; Drug: IBI355

• Registration Number: NCT06416787
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Brief Summary

This study aims to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of IBI355 in Healthy voluteers. This study also aims to evaluate the anti-Drug antibody after multiple ascending doses of IBI355 in Healthy voluteers.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-11
• Study First Submitted QC: 2024-05-15
• Study First Posted: 2024-05-16
• Study Start: 2024-05-20
• Primary Completion: 2025-02-26
• Study Completion: 2025-04-02
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

1. Understanding and Signing a written informed consent prior to selection;
2. Aged above 18 years old, male or female;
3. Body mass index (BMI) between 18-28kg/m2;
4. Normal lable test;
5. No parenting plan for at least 6 months

Exclusion Criteria

1. Subjects with a history of allergy；
2. Subjects paticipated in the other clinical trail in 1 month or less than 5 t1/2 since the previous clinical trial (which is longer)；
3. Subjects with an infection requiring systemic medication was present within 30 days prior to randomization;
4. HIV-Ab、RPR、HCV-Ab、HBV、HBeAg or HBcAb, one of them positive;
5. There have a clinical or imaging evidence that the subject with active tuberculosis, or there is evidence that the subject is in the incubation period for tuberculosis;
6. Patients with a history of central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, metabolic disorders and other systemic diseases;
7. Subject with a hcg positive;
8. Patients with a history of neuropsychiatry or who are considered unfit to participate in this clinical trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IBI355 dose-4	placebo	IBI355 30mg/kg and placebo will be given to the subjects every 4 weeks (6:2)
IBI355 dose-1	placebo	IBI355 1mg/kg and placebo will be given to the subjects every 4 weeks (6:2)
IBI355 dose-3	IBI355	IBI355 15mg/kg and placebo will be given to the subjects every 4 weeks (6:2)
IBI355 dose-4	IBI355	IBI355 30mg/kg and placebo will be given to the subjects every 4 weeks (6:2)
IBI355 dose-2	placebo	IBI355 7.5mg/kg and placebo will be given to the subjects every 4 weeks (6:2)
IBI355 dose-3	placebo	IBI355 15mg/kg and placebo will be given to the subjects every 4 weeks (6:2)
IBI355 dose-2	IBI355	IBI355 7.5mg/kg and placebo will be given to the subjects every 4 weeks (6:2)
IBI355 dose-1	IBI355	IBI355 1mg/kg and placebo will be given to the subjects every 4 weeks (6:2)

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events and serious adverse events	Up to week 24

Secondary Outcome Measures

Name	Time	Method
Half-life (t1/2) of multi-dose of IBI355	Up to week 12
The ratio of Anti-drug antibody of multi-dose of IBI355	Up to week 24
Area under the Curve(AUC) of multi-dose of IBI355	Up to week 12
Clearance (CL) of multi-dose of IBI355	Up to week 12
Peak serum concentration(Cmax) of multi-dose of IBI355	Up to week 12

Trial Locations

Locations (1)

Aerospace Center Hospital; 🇨🇳 Beijing, Beijing, China