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OpenTrials
Completed

NCT Number: NCT06416787

Safety and Tolerability of IBI355 in Healthy Volunteers

This study aims to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of IBI355 in Healthy volunteers. This study also aims to evaluate the anti-Drug antibody after multiple ascending doses of IBI355 in Healthy volunteers.

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Aerospace Center Hospital

Beijing, Beijing Municipality, 100049, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Understanding and Signing a written informed consent prior to selection;
  • Aged above 18 years old, male or female;
  • Body mass index (BMI) between 18-28kg/m2;
  • Normal label test;
  • No parenting plan for at least 6 months

Exclusion criteria

  • Subjects with a history of allergy；
  • Subjects participated in the other clinical trail in 1 month or less than 5 t1/2 since the previous clinical trial (which is longer)；
  • Subjects with an infection requiring systemic medication was present within 30 days prior to randomization;
  • HIV-Ab、RPR、HCV-Ab、HBV、HBeAg or HBcAb, one of them positive;
  • There have a clinical or imaging evidence that the subject with active tuberculosis, or there is evidence that the subject is in the incubation period for tuberculosis;
  • Patients with a history of central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, metabolic disorders and other systemic diseases;
  • Subject with a hcg positive;
  • Patients with a history of neuropsychiatry or who are considered unfit to participate in this clinical trial

Treatment and study plan

Placebo

Drug

IBI355 7.5mg/kg Q4W

IBI355

Drug

IBI355 1mg/kg Q4W

Primary outcomes

  1. Incidence of adverse events and serious adverse events

    Time frame: Up to week 24

Secondary outcomes

  1. Area under the Curve(AUC) of multi-dose of IBI355

    Time frame: Up to week 12

  2. Peak serum concentration(Cmax) of multi-dose of IBI355

    Time frame: Up to week 12

  3. Clearance (CL) of multi-dose of IBI355

    Time frame: Up to week 12

  4. Half-life (t1/2) of multi-dose of IBI355

    Time frame: Up to week 12

  5. The ratio of Anti-drug antibody of multi-dose of IBI355

    Time frame: Up to week 24

Sponsors and collaborators

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Industry

Registry information

Official study title

A Double Blind, Randomized Study Assessing the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of IBI355 in Healthy Volunteers

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 16, 2024
Registry last updated
May 21, 2025

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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