NCT06110338

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

October 30, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 31, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2024

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2024

Completed
Last Updated

October 21, 2024

Status Verified

October 1, 2024

Enrollment Period

11 months

First QC Date

October 26, 2023

Last Update Submit

October 17, 2024

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

  • Incidence of AE、SAE after receiving IBI 355

    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

    week 0-12

Study Arms (7)

IBI355 dose 1

EXPERIMENTAL

IBI355 0.3mg/kg and placebo will be given to the subjects (3:2)

Drug: placeboDrug: IBI355

IBI355 dose 4

EXPERIMENTAL

IBI355 7.5mg/kg and placebo will be given to the subjects (6:2)

Drug: placeboDrug: IBI355

IBI355 dose 6

EXPERIMENTAL

IBI355 25mg/kg and placebo will be given to the subjects (6:2)

Drug: placeboDrug: IBI355

IBI355 dose 7

EXPERIMENTAL

IBI355 35mg/kg and placebo will be given to the subjects (6:2)

Drug: placeboDrug: IBI355

IBI355 dose 2

EXPERIMENTAL

IBI355 1mg/kg and placebo will be given to the subjects (6:2)

Drug: placeboDrug: IBI355

IBI355 dose 3

EXPERIMENTAL

IBI355 3mg/kg and placebo will be given to the subjects (6:2)

Drug: placeboDrug: IBI355

IBI355 dose 5

EXPERIMENTAL

IBI355 15mg/kg and placebo will be given to the subjects (6:2)

Drug: placeboDrug: IBI355

Interventions

placeboDRUG

placebo iv. once.

IBI355 dose 1IBI355 dose 2IBI355 dose 3IBI355 dose 4IBI355 dose 5IBI355 dose 6IBI355 dose 7
IBI355DRUG

IBI355 iv. once.

IBI355 dose 1IBI355 dose 2IBI355 dose 3IBI355 dose 4IBI355 dose 5IBI355 dose 6IBI355 dose 7

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aerospace Center Hospital

Beijing, Beijing Municipality, 100049, China

Location

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

October 26, 2023

First Posted

October 31, 2023

Study Start

October 30, 2023

Primary Completion

September 20, 2024

Study Completion

September 23, 2024

Last Updated

October 21, 2024

Record last verified: 2024-10

Locations

CN(1)