Safety and Tolerability of IBI355 in Healthy Volunteers

NCT06416787 | Completed Phase 1

• 1 other identifier: CIBI355A103
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events and serious adverse events

  Up to week 24

Secondary Outcomes (5)

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

  Up to week 12

• Peak serum concentration(Cmax) of multi-dose of IBI355

  Up to week 12

• Clearance (CL) of multi-dose of IBI355

  Up to week 12

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

  Up to week 12

• The ratio of Anti-drug antibody of multi-dose of IBI355

  Up to week 24

Study Arms (4)

IBI355 dose-3

EXPERIMENTAL

IBI355 15mg/kg and placebo will be given to the subjects every 4 weeks (6:2)

Drug: placebo; Drug: IBI355

IBI355 dose-1

EXPERIMENTAL

IBI355 1mg/kg and placebo will be given to the subjects every 4 weeks (6:2)

Drug: placebo; Drug: IBI355

IBI355 dose-4

EXPERIMENTAL

IBI355 30mg/kg and placebo will be given to the subjects every 4 weeks (6:2)

Drug: placebo; Drug: IBI355

IBI355 dose-2

EXPERIMENTAL

IBI355 7.5mg/kg and placebo will be given to the subjects every 4 weeks (6:2)

Drug: placebo; Drug: IBI355

Interventions

placebo DRUG

IBI355 7.5mg/kg Q4W

IBI355 dose-1; IBI355 dose-2; IBI355 dose-3; IBI355 dose-4

IBI355 DRUG

IBI355 1mg/kg Q4W

IBI355 dose-1; IBI355 dose-2; IBI355 dose-3; IBI355 dose-4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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

Sponsors & Collaborators

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

Study Sites (1)

Aerospace Center Hospital

Beijing, Beijing Municipality, 100049, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2024
• First Posted: May 16, 2024
• Study Start: May 20, 2024
• Primary Completion: February 26, 2025
• Study Completion: April 2, 2025
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)