Single Dose Tolerability and Pharmacokinetics of IBI112 in Healthy Subjects

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04511624
• Other study ID #: CIBI112A101
• Status: Completed
• Phase: Phase 1
• Start date: August 27, 2020
• Est. completion date: July 22, 2022

Study information

• Verified date: September 2022
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: July 22, 2022
• Est. primary completion date: July 22, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• IBI112 dose1
Drug: IBI112 SC dose1 Drug:placebo
• IBI112 dose2
Drug: IBI112 SC dose2 Drug:placebo
• IBI112 dose3
Drug: IBI112 SC dose3 Drug:placebo
• IBI112 dose4
Drug: IBI112 SC dose4 Drug:placebo
• IBI112 dose5
Drug: IBI112 IV dose5 Drug:placebo
• IBI112 dose6
Drug: IBI112 SC dose6 Drug:placebo
• IBI112 dose7
Drug: IBI112 IV dose7 Drug:placebo

Locations

Country	Name	City	State
China	Huashan Hospital Affiliated to Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment-emergent adverse events in healthy volunteers with single ascending doses of IBI112		Day1 to Day 113 post dose
Secondary	Maximum Concentration (Cmax) - Pharmacokinetic Assessment	IV dose & SC dose	Day 113
Secondary	Time to Maximum Concentration (Tmax) - Pharmacokinetic Assessment	SC dose	Day 113
Secondary	Area Under the Curve Extrapolated to Infinity (AUC0-8) - Pharmacokinetic Assessment	IV dose & SC dose	Day 113
Secondary	Half-Life (t1/2) - Pharmacokinetic Assessment	IV dose & SC dose	Day 113
Secondary	Volume of Distribution (Vd) - Pharmacokinetic Assessment	IV dose & SC dose	Day 113