Safety and Tolerability of IBI355 in Healthy Volunteers

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06416787
• Other study ID #: CIBI355A103
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: May 17, 2024
• Est. completion date: December 30, 2025

Study information

• Verified date: May 2024
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: Yang Yu
• Phone: 0512-69566088
• Email: yang.yu[@]innoventbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: December 30, 2025
• Est. primary completion date: February 13, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Understanding and Signing a written informed consent prior to selection;

2. Aged above 18 years old, male or female;

3. Body mass index (BMI) between 18-28kg/m2;

4. Normal lable test;

5. No parenting plan for at least 6 months

Exclusion Criteria:

1. Subjects with a history of allergy;

2. Subjects paticipated in the other clinical trail in 1 month or less than 5 t1/2 since the previous clinical trial (which is longer);

3. Subjects with an infection requiring systemic medication was present within 30 days prior to randomization;

4. HIV-Ab?RPR?HCV-Ab?HBV?HBeAg or HBcAb, one of them positive;

5. 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;

6. Patients with a history of central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, metabolic disorders and other systemic diseases;

7. Subject with a hcg positive;

8. Patients with a history of neuropsychiatry or who are considered unfit to participate in this clinical trial

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• placebo
IBI355 7.5mg/kg Q4W
• IBI355
IBI355 1mg/kg Q4W

Locations

Country	Name	City	State
China	Aerospace Center Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events and serious adverse events		Up to week 24
Secondary	Area under the Curve(AUC) of multi-dose of IBI355		Up to week 12
Secondary	Peak serum concentration(Cmax) of multi-dose of IBI355		Up to week 12
Secondary	Clearance (CL) of multi-dose of IBI355		Up to week 12
Secondary	Half-life (t1/2) of multi-dose of IBI355		Up to week 12
Secondary	The ratio of Anti-drug antibody of multi-dose of IBI355		Up to week 24