A Study of IBI311 in Healthy Volunteers

A Dose Escalation Phase I Clinical Study to Evaluate the Tolerability and Safety of a Single Intravenous Injection IBI311 in Healthy Volunteers

It is designed for Multi-center, double-masked, randomized, placebo- control study with dose escalation phase I trial to evaluate the safety, tolerability, PK and immunogenicity profiles of a single intravenous injection of IBI311 in healthy volunteers.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Biological: IBI311; Biological: IBI311; Biological: IBI311; Biological: IBI311; Biological: placebo; Biological: placebo; Biological: placebo; Biological: placebo

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200041
      • Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Willing and able to sign informed consent form and comply with visit and study procedures per protocol.
2. Male or female subjects with age of 18~45 yrs.
3. Female subjects of childbearing age or male subjects with childbearing age female partner agree to take effective contraceptive measures from the screening period to 120 days after the end of treatment.

Exclusion Criteria:

1. Have a history of or any evidence of chronic diseases of liver, kidney, cardiovascular, nervous/mental, digestive tract, respiratory, urinary and endocrine systems.
2. Have received prior treatment with another anti-IGF-1R monoclonal antibody.
3. History of drug, alcohol, or chemical abuse within 6 months prior to screening.
4. History of positive HIV antibody, HCV antibody, Syphilis check, HBV positive during screening period.
5. Receipt of a live vaccine within 180 days prior to screening or expected to receive live vaccine during study period.
6. History of recurrent significant infection or history of recurrent bacterial infections.
7. Must not have a history of tinnitus or hearing impairment.
8. Must not have received an investigational agent for any condition within 90 days.
9. Female volunteers must not be pregnant or lactating.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1: treated with different doses of single intravenous injection of IBI311	Biological: IBI311; Dose2 IBI311 of single IV injection; Biological: IBI311; Dose4 IBI311 of single IV injection; Biological: IBI311; Dose1 IBI311 of single IV injection; Biological: IBI311; Dose 3 IBI311 of single IV injection
Placebo Comparator: Cohort 1: placebo group	Biological: placebo; Dose4 placebo of single IV injection; Biological: placebo; Dose3 placebo of single IV injection; Biological: placebo; Dose1 placebo of single IV injection; Biological: placebo; Dose2 placebo of single IV injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence, relatedness and severity of all adverse events, treatment emergent adverse events and serious adverse events	Up to 16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
maximum concentration (Cmax）	PK parameters maximum concentration (Cmax） of IBI311	Up to 16 weeks.
area under the curve (AUC)	PK parameters area under the curve (AUC) of IBI311	Up to 16 weeks.
half-life (t1/2)	PK parameters half-life (t1/2) of IBI311	Up to 16 weeks.
the incidence of ADA	Positive rate of anti-drug antibody	Up to 16 weeks

Collaborators and Investigators

• Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
• Investigators: Principal Investigator: Yongfang Yuan, Ph D., Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2022
• Primary Completion (Actual): November 23, 2022
• Study Completion (Actual): January 19, 2023

Study Registration Dates

• First Submitted: July 15, 2022
• First Submitted That Met QC Criteria: July 27, 2022
• First Posted (Actual): July 29, 2022

Study Record Updates

• Last Update Posted (Actual): October 11, 2023
• Last Update Submitted That Met QC Criteria: October 9, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: CIBI311A101

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
• product manufactured in and exported from the U.S.: No