Safety and Tolerability of IBI355 in Healthy Volunteers

Innovent Biologics

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: placebo; Drug: IBI355

Study type: Interventional

Funder types: Industry

Identifiers

NCT06416787

CIBI355A103

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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 label test;
5. No parenting plan for at least 6 months

Exclusion criteria

1. Subjects with a history of allergy；
2. Subjects participated 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 4 patient groups

IBI355 dose-3

Experimental group

Description:

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

Treatment:

Drug: IBI355

Drug: placebo

IBI355 dose-1

Experimental group

Description:

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

Treatment:

Drug: IBI355

Drug: placebo

IBI355 dose-4

Experimental group

Description:

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

Treatment:

Drug: IBI355

Drug: placebo

IBI355 dose-2

Experimental group

Description:

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

Treatment:

Drug: IBI355

Drug: placebo