Safety and Tolerability of IBI355 in Healthy Volunteers

A Double Blind, Randomized Study Assessing the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of IBI355 in Healthy Voluteers

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: placebo; Drug: IBI355

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yang Yu; Phone Number: 0512-69566088; Email: yang.yu@innoventbio.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100049
      • Aerospace Center Hospital
      • Contact: Jin Wang; Phone Number: 010-59971772; Email: wjlsq@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IBI355 dose-3; IBI355 15mg/kg and placebo will be given to the subjects every 4 weeks (6:2)	Drug: placebo; IBI355 7.5mg/kg Q4W; Drug: IBI355; IBI355 1mg/kg Q4W
Experimental: IBI355 dose-1; IBI355 1mg/kg and placebo will be given to the subjects every 4 weeks (6:2)	Drug: placebo; IBI355 7.5mg/kg Q4W; Drug: IBI355; IBI355 1mg/kg Q4W
Experimental: IBI355 dose-4; IBI355 30mg/kg and placebo will be given to the subjects every 4 weeks (6:2)	Drug: placebo; IBI355 7.5mg/kg Q4W; Drug: IBI355; IBI355 1mg/kg Q4W
Experimental: IBI355 dose-2; IBI355 7.5mg/kg and placebo will be given to the subjects every 4 weeks (6:2)	Drug: placebo; IBI355 7.5mg/kg Q4W; Drug: IBI355; IBI355 1mg/kg Q4W

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of adverse events and serious adverse events	Up to week 24

Secondary Outcome Measures

Outcome Measure	Time Frame
Area under the Curve(AUC) of multi-dose of IBI355	Up to week 12
Peak serum concentration(Cmax) of multi-dose of IBI355	Up to week 12
Clearance (CL) of multi-dose of IBI355	Up to week 12
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

Collaborators and Investigators

• Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): May 17, 2024
• Primary Completion (Estimated): February 13, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: May 11, 2024
• First Submitted That Met QC Criteria: May 15, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 15, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: CIBI355A103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No