Single Dose Tolerability and Pharmacokinetics of IBI112 in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: IBI112 dose3; Drug: IBI112 dose5; Drug: IBI112 dose2; Drug: IBI112 dose7; Drug: IBI112 dose1; Drug: IBI112 dose4; Drug: IBI112 dose6

• Registration Number: NCT04511624
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

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

Detailed Description

In this first in human, phase 1, randomized, double-blind, placebo-controlled study, a single subcutaneous or intravenous dose of IBI112 will be administered to 46 healthy subjects.

Study Timeline

• Study First Submitted: 2020-08-03
• Study First Submitted QC: 2020-08-12
• Study First Posted: 2020-08-13
• Study Start: 2020-08-27
• Primary Completion: 2022-07-22
• Study Completion: 2022-07-22
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-16
• Last Update Posted: 2022-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

1. Healthy male or female 18 to 45 years of age at the time of consent
2. BMI of 19-26Kg/m2 and weight of 50-100kg
3. 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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cohort 3	IBI112 dose3	IBI112 SC dose3
Cohort 5	IBI112 dose5	IBI112 IV dose3
Cohort 2	IBI112 dose2	IBI112 SC dose2
Cohort 7	IBI112 dose7	IBI112 IV dose5
Cohort 1	IBI112 dose1	IBI112 SC dose1
Cohort 4	IBI112 dose4	IBI112 IV dose4
Cohort 6	IBI112 dose6	IBI112 SC dose5

Primary Outcome Measures

Name	Time	Method
Incidence of treatment-emergent adverse events in healthy volunteers with single ascending doses of IBI112	Day1 to Day 113 post dose

Secondary Outcome Measures

Name	Time	Method
Volume of Distribution (Vd) - Pharmacokinetic Assessment	Day 113	IV dose \& SC dose
Maximum Concentration (Cmax) - Pharmacokinetic Assessment	Day 113	IV dose \& SC dose
Time to Maximum Concentration (Tmax) - Pharmacokinetic Assessment	Day 113	SC dose
Area Under the Curve Extrapolated to Infinity (AUC0-∞) - Pharmacokinetic Assessment	Day 113	IV dose \& SC dose
Half-Life (t1/2) - Pharmacokinetic Assessment	Day 113	IV dose \& SC dose

Trial Locations

Locations (1)

Huashan Hospital Affiliated to Fudan University; 🇨🇳 Shanghai, China