A Study of IBI311 in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Biological: IBI311; Biological: placebo

• Registration Number: NCT05480579
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-15
• Study First Submitted QC: 2022-07-27
• Study First Posted: 2022-07-29
• Study Start: 2022-08-10
• Primary Completion: 2022-11-23
• Study Completion: 2023-01-19
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-09
• Last Update Posted: 2023-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cohort 1: treated with different doses of single intravenous injection of IBI311	IBI311	-
Cohort 1: placebo group	placebo	-

Primary Outcome Measures

Name	Time	Method
Incidence, relatedness and severity of all adverse events, treatment emergent adverse events and serious adverse events	Up to 16 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China