Safety and Tolerance Study of IBI355 in Health Volunteers

A Phase 1, Double-blind Study to Evaluate the Safety and Tolerability of a Single-dose Administration of IBI355 in Health Adults

This study is being done to find out if IBI355 is safe and tolerance in health volunteers. The study will test increasing single doses of IBI355 given to adult health volunteers. The goal is to confirmed the safety of the highest dose of IBI355 or to find out the highest dose of IBI35 that can be given to health volunteer that dose not cause unacceptable side effects. Different dose regimens will be evaluated. The pharmacokinetics and ADA of IBI355 will also be evaluated.

Study Overview

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

• Study Type: Interventional
• Enrollment (Estimated): 53
• 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. Subjects who have decided to voluntarily participate in the study and provided a written consent regarding observance of precautions after having been informed of and having fully understood the objectives, methods, and effects of the study in detail;
2. Healthy male and female aged 18 years or above ;
3. Subject with a Body Mass Index (BMI)* between 18.5 and 28.0 kg/㎡;
4. subjects with a normal laboratory examination，ECG， X-ray.

Exclusion Criteria:

1. Subjects with a history of allergy；
2. Subjects participated 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: Sequential Assignment
• Masking: Double

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IBI355 dose 1; IBI355 0.3mg/kg and placebo will be given to the subjects (3:2)	Drug: placebo; placebo iv. once.; Drug: IBI355; IBI355 iv. once.
Experimental: IBI355 dose 4; IBI355 7.5mg/kg and placebo will be given to the subjects (6:2)	Drug: placebo; placebo iv. once.; Drug: IBI355; IBI355 iv. once.
Experimental: IBI355 dose 6; IBI355 25mg/kg and placebo will be given to the subjects (6:2)	Drug: placebo; placebo iv. once.; Drug: IBI355; IBI355 iv. once.
Experimental: IBI355 dose 7; IBI355 35mg/kg and placebo will be given to the subjects (6:2)	Drug: placebo; placebo iv. once.; Drug: IBI355; IBI355 iv. once.
Experimental: IBI355 dose 2; IBI355 1mg/kg and placebo will be given to the subjects (6:2)	Drug: placebo; placebo iv. once.; Drug: IBI355; IBI355 iv. once.
Experimental: IBI355 dose 3; IBI355 3mg/kg and placebo will be given to the subjects (6:2)	Drug: placebo; placebo iv. once.; Drug: IBI355; IBI355 iv. once.
Experimental: IBI355 dose 5; IBI355 15mg/kg and placebo will be given to the subjects (6:2)	Drug: placebo; placebo iv. once.; Drug: IBI355; IBI355 iv. once.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of AE、SAE after receiving IBI 355	week 0-12

Secondary Outcome Measures

Outcome Measure	Time Frame
Area Under Curve, (AUC）、Maximum serum concentration of drug(Cmax）、Clearance (CL）、Apparent volume of distribution(V） and Half- life(t1/2）of IBI355	week 0-12

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): October 31, 2023
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: October 26, 2023
• First Submitted That Met QC Criteria: October 26, 2023
• First Posted (Actual): October 31, 2023

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 26, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: CIBI355A101CN

Drug and device information, study documents

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