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Completed

NCT Number: NCT06110338

Safety and Tolerance Study of IBI355 in Health Volunteers

This study is being done to find out if IBI355 is safe and tolerance in health volunteers. The study will test increasing single doses of IBI355 given to adult health volunteers. The goal is to confirmed the safety of the highest dose of IBI355 or to find out the highest dose of IBI35 that can be given to health volunteer that dose not cause unacceptable side effects. Different dose regimens will be evaluated. The pharmacokinetics and ADA of IBI355 will also be evaluated.

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Key information

Conditions

Healthy Subjects

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

  • Subjects who have decided to voluntarily participate in the study and provided a written consent regarding observance of precautions after having been informed of and having fully understood the objectives, methods, and effects of the study in detail;
  • Healthy male and female aged 18 years or above ;
  • Subject with a Body Mass Index (BMI)* between 18.5 and 28.0 kg/㎡;
  • subjects with a normal laboratory examination，ECG， X-ray.

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

placebo iv. once.

IBI355

Drug

IBI355 iv. once.

Primary outcomes

  1. Incidence of AE、SAE after receiving IBI 355

    Time frame: week 0-12

Secondary outcomes

  1. Area Under Curve, (AUC）、Maximum serum concentration of drug(Cmax）、Clearance (CL）、Apparent volume of distribution(V） and Half- life(t1/2）of IBI355

    Time frame: week 0-12

Sponsors and collaborators

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Industry

Registry information

Official study title

A Phase 1, Double-blind Study to Evaluate the Safety and Tolerability of a Single-dose Administration of IBI355 in Health Adults

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 31, 2023
Registry last updated
Oct 21, 2024

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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