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Single Dose Tolerability and Pharmacokinetics of IBI112 in Healthy Subjects

NCT04511624 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2022-09-19

No results posted yet for this study

Summary

This is a the first in human study to evaluate the safety, tolerability, PK and PD of single subcutaneous or intravenous dose of IBI112 in healthy subjects

Conditions

  • Healthy Subjects

Interventions

DRUG

IBI112 dose1

Drug: IBI112 SC dose1 Drug:placebo

DRUG

IBI112 dose2

Drug: IBI112 SC dose2 Drug:placebo

DRUG

IBI112 dose3

Drug: IBI112 SC dose3 Drug:placebo

DRUG

IBI112 dose4

Drug: IBI112 SC dose4 Drug:placebo

DRUG

IBI112 dose5

Drug: IBI112 IV dose5 Drug:placebo

DRUG

IBI112 dose6

Drug: IBI112 SC dose6 Drug:placebo

DRUG

IBI112 dose7

Drug: IBI112 IV dose7 Drug:placebo

Sponsors & Collaborators

  • Innovent Biologics (Suzhou) Co. Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-27
Primary Completion
2022-07-22
Completion
2022-07-22

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04511624 on ClinicalTrials.gov