NCT04511624
Completed
Phase 1
A Phase I Randomized, Double-Blind, Placebo-Controlled, Single Subcutaneous or Intravenous Ascending Dose Trial to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IBI112 in Healthy Subjects
ConditionsHealthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- IBI112 dose1
- Conditions
- Healthy Subjects
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- Incidence of treatment-emergent adverse events in healthy volunteers with single ascending doses of IBI112
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Cohort 1
IBI112 SC dose1
Intervention: IBI112 dose1
Cohort 2
IBI112 SC dose2
Intervention: IBI112 dose2
Cohort 3
IBI112 SC dose3
Intervention: IBI112 dose3
Cohort 4
IBI112 IV dose4
Intervention: IBI112 dose4
Cohort 5
IBI112 IV dose3
Intervention: IBI112 dose5
Cohort 6
IBI112 SC dose5
Intervention: IBI112 dose6
Cohort 7
IBI112 IV dose5
Intervention: IBI112 dose7
Outcomes
Primary Outcomes
Incidence of treatment-emergent adverse events in healthy volunteers with single ascending doses of IBI112
Time Frame: Day1 to Day 113 post dose
Secondary Outcomes
- Volume of Distribution (Vd) - Pharmacokinetic Assessment(Day 113)
- 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)
Study Sites (1)
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