Safety and Tolerability of IBI355 in Healthy Volunteers

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06416787

Enrollment

Registered

2024-05-16

Start date

2024-05-20

Completion date

2025-04-02

Last updated

2025-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DRUGplacebo

IBI355 7.5mg/kg Q4W

DRUGIBI355

IBI355 1mg/kg Q4W

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Incidence of adverse events and serious adverse events	Up to week 24

Secondary

Measure	Time frame
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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026