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OpenTrials
Completed

NCT Number: NCT05480579

A Study of 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.

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Shanghai, Shanghai Municipality, 200041, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Placebo

Biological

Dose4 placebo of single IV injection

IBI311

Biological

Dose2 IBI311 of single IV injection

Primary outcomes

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

    Time frame: Up to 16 weeks

Secondary outcomes

  1. maximum concentration (Cmax）

    Time frame: Up to 16 weeks.

    PK parameters maximum concentration (Cmax） of IBI311

  2. area under the curve (AUC)

    Time frame: Up to 16 weeks.

    PK parameters area under the curve (AUC) of IBI311

  3. half-life (t1/2)

    Time frame: Up to 16 weeks.

    PK parameters half-life (t1/2) of IBI311

  4. the incidence of ADA

    Time frame: Up to 16 weeks

    Positive rate of anti-drug antibody

Sponsors and collaborators

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jul 29, 2022
Registry last updated
Oct 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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