A Study of IBI311 in Healthy Volunteers

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05480579
• Other study ID #: CIBI311A101
• Status: Completed
• Phase: Phase 1
• 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
• 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.

Related Conditions & MeSH terms

• Healthy

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