Single Dose Tolerability and Pharmacokinetics of IBI112 in Healthy Subjects

NCT04511624 | Completed Phase 1

• 1 other identifier: CIBI112A101
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment-emergent adverse events in healthy volunteers with single ascending doses of IBI112

  Day1 to Day 113 post dose

Secondary Outcomes (5)

• Maximum Concentration (Cmax) - Pharmacokinetic Assessment

  Day 113

• Time to Maximum Concentration (Tmax) - Pharmacokinetic Assessment

  Day 113

• Area Under the Curve Extrapolated to Infinity (AUC0-∞) - Pharmacokinetic Assessment

  Day 113

• Half-Life (t1/2) - Pharmacokinetic Assessment

  Day 113

• Volume of Distribution (Vd) - Pharmacokinetic Assessment

  Day 113

Study Arms (7)

Cohort 1

EXPERIMENTAL

IBI112 SC dose1

Drug: IBI112 dose1

Cohort 2

EXPERIMENTAL

IBI112 SC dose2

Drug: IBI112 dose2

Cohort 3

EXPERIMENTAL

IBI112 SC dose3

Drug: IBI112 dose3

Cohort 4

EXPERIMENTAL

IBI112 IV dose4

Drug: IBI112 dose4

Cohort 5

EXPERIMENTAL

IBI112 IV dose3

Drug: IBI112 dose5

Cohort 6

EXPERIMENTAL

IBI112 SC dose5

Drug: IBI112 dose6

Cohort 7

EXPERIMENTAL

IBI112 IV dose5

Drug: IBI112 dose7

Interventions

IBI112 dose1 DRUG

Drug: IBI112 SC dose1 Drug:placebo

Cohort 1

IBI112 dose2 DRUG

Drug: IBI112 SC dose2 Drug:placebo

Cohort 2

IBI112 dose3 DRUG

Drug: IBI112 SC dose3 Drug:placebo

Cohort 3

IBI112 dose4 DRUG

Drug: IBI112 SC dose4 Drug:placebo

Cohort 4

IBI112 dose5 DRUG

Drug: IBI112 IV dose5 Drug:placebo

Cohort 5

IBI112 dose6 DRUG

Drug: IBI112 SC dose6 Drug:placebo

Cohort 6

IBI112 dose7 DRUG

Drug: IBI112 IV dose7 Drug:placebo

Cohort 7

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female 18 to 45 years of age at the time of consent
• BMI of 19-26Kg/m2 and weight of 50-100kg
• Must provide written informed consent, and in the investigator's opinion, subject is able to understand the nature of the study and any risks involved in participation, and willing to cooperate and comply with the protocol restrictions and requirements

You may not qualify if:

• Subjects who have a medical history of liver, kidney, cardiovascular, nervous / mental, gastrointestinal, respiratory, urinary, endocrine
• Subjects who have a history of relapse or chronic infection, or a history of acute infection within 2 weeks;
• Subjects who have previously used anti-IL-12 / 23 or anti-il-23 drugs;
• Subjects who have clinically significant abnormalities determined by vital signs, physical examination, and laboratory measurements;
• Subjects who are not suitable for this trial due to other reasons In the investigator' opinion

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (1)

Huashan Hospital Affiliated to Fudan University

Shanghai, China

Location

Related Publications (1)

• He J, Du W, Yang H, Wang J, Cai C, Ma Q, Li N, Yu J, Wu X, Wu J, Chen Y, Cao G, Zhang J. Safety and pharmacokinetics of IBI112, an IL-23 monoclonal antibody, in Chinese healthy volunteers: a first-in-human phase 1 study. Expert Opin Investig Drugs. 2023 Jul-Dec;32(7):669-675. doi: 10.1080/13543784.2023.2230122. Epub 2023 Jun 29.

  PMID: 37358916 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2020
• First Posted: August 13, 2020
• Study Start: August 27, 2020
• Primary Completion: July 22, 2022
• Study Completion: July 22, 2022
• Last Updated: September 19, 2022

Record last verified: 2022-09

Locations

CN (1)