Safety and Tolerability of IBI355 in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-20

Study Completion Date

2025-04-02

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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IBI355 dose-3

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

Group Type EXPERIMENTAL

placebo

Intervention Type DRUG

IBI355 7.5mg/kg Q4W

IBI355

Intervention Type DRUG

IBI355 1mg/kg Q4W

IBI355 dose-1

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

Group Type EXPERIMENTAL

placebo

Intervention Type DRUG

IBI355 7.5mg/kg Q4W

IBI355

Intervention Type DRUG

IBI355 1mg/kg Q4W

IBI355 dose-4

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

Group Type EXPERIMENTAL

placebo

Intervention Type DRUG

IBI355 7.5mg/kg Q4W

IBI355

Intervention Type DRUG

IBI355 1mg/kg Q4W

IBI355 dose-2

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

Group Type EXPERIMENTAL

placebo

Intervention Type DRUG

IBI355 7.5mg/kg Q4W

IBI355

Intervention Type DRUG

IBI355 1mg/kg Q4W

Interventions

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placebo

IBI355 7.5mg/kg Q4W

Intervention Type DRUG

IBI355

IBI355 1mg/kg Q4W

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes