A Study of IBI311 in Healthy Volunteers

NCT05480579 | Completed Phase 1

• 1 other identifier: CIBI311A101
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Incidence, relatedness and severity of all adverse events, treatment emergent adverse events and serious adverse events

  Up to 16 weeks

Secondary Outcomes (4)

• maximum concentration (Cmax）

  Up to 16 weeks.

• area under the curve (AUC)

  Up to 16 weeks.

• half-life (t1/2)

  Up to 16 weeks.

• the incidence of ADA

  Up to 16 weeks

Study Arms (2)

Cohort 1: treated with different doses of single intravenous injection of IBI311

EXPERIMENTAL

Biological: IBI311

Cohort 1: placebo group

PLACEBO COMPARATOR

Biological: placebo

Interventions

placebo BIOLOGICAL

Dose4 placebo of single IV injection

Cohort 1: placebo group

IBI311 BIOLOGICAL

Dose2 IBI311 of single IV injection

Cohort 1: treated with different doses of single intravenous injection of IBI311

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Willing and able to sign informed consent form and comply with visit and study procedures per protocol.
• Male or female subjects with age of 18\~45 yrs.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200041, China

Location

Study Officials

• Yongfang Yuan, Ph D.

  Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2022
• First Posted: July 29, 2022
• Study Start: August 10, 2022
• Primary Completion: November 23, 2022
• Study Completion: January 19, 2023
• Last Updated: October 11, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)