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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05480579
Other study ID # CIBI311A101
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date August 10, 2022
Est. completion date January 19, 2023

Study information

Verified date October 2023
Source Innovent Biologics (Suzhou) Co. Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date January 19, 2023
Est. primary completion date November 23, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Biological:
placebo
Dose4 placebo of single IV injection
IBI311
Dose2 IBI311 of single IV injection
IBI311
Dose4 IBI311 of single IV injection
placebo
Dose3 placebo of single IV injection
placebo
Dose1 placebo of single IV injection
IBI311
Dose1 IBI311 of single IV injection
IBI311
Dose 3 IBI311 of single IV injection
placebo
Dose2 placebo of single IV injection

Locations

Country Name City State
China Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine Shanghai Shanghai

Sponsors (1)

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

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence, relatedness and severity of all adverse events, treatment emergent adverse events and serious adverse events Up to 16 weeks
Secondary maximum concentration (Cmax) PK parameters maximum concentration (Cmax) of IBI311 Up to 16 weeks.
Secondary area under the curve (AUC) PK parameters area under the curve (AUC) of IBI311 Up to 16 weeks.
Secondary half-life (t1/2) PK parameters half-life (t1/2) of IBI311 Up to 16 weeks.
Secondary the incidence of ADA Positive rate of anti-drug antibody Up to 16 weeks
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