Healthy SubjectsPhase 1NCT04511624
Single Dose Tolerability and Pharmacokinetics of IBI112 in Healthy Subjects
A Phase 1 study testing IBI112 dose1, IBI112 dose2 and IBI112 dose3 in people with Healthy Subjects, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
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 Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- IBI112 dose1, IBI112 dose2 and IBI112 dose3
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 27 Aug 2020to 22 Jul 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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.
- Conditions
- Healthy Subjects
- Being tested
- IBI112 dose1, IBI112 dose2, IBI112 dose3, IBI112 dose4, IBI112 dose5
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI112 dose1Drug
Drug: IBI112 SC dose1 Drug:placebo
IBI112 dose2Drug
Drug: IBI112 SC dose2 Drug:placebo
IBI112 dose3Drug
Drug: IBI112 SC dose3 Drug:placebo
IBI112 dose4Drug
Drug: IBI112 SC dose4 Drug:placebo
IBI112 dose5Drug
Drug: IBI112 IV dose5 Drug:placebo
IBI112 dose6Drug
Drug: IBI112 SC dose6 Drug:placebo
IBI112 dose7Drug
Drug: IBI112 IV dose7 Drug:placebo
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | IBI112 SC dose1 Receives: Drug: IBI112 dose1 |
| Cohort 2 | Experimental | IBI112 SC dose2 Receives: Drug: IBI112 dose2 |
| Cohort 3 | Experimental | IBI112 SC dose3 Receives: Drug: IBI112 dose3 |
| Cohort 4 | Experimental | IBI112 IV dose4 Receives: Drug: IBI112 dose4 |
| Cohort 5 | Experimental | IBI112 IV dose3 Receives: Drug: IBI112 dose5 |
| Cohort 6 | Experimental | IBI112 SC dose5 Receives: Drug: IBI112 dose6 |
| Cohort 7 | Experimental | IBI112 IV dose5 Receives: Drug: IBI112 dose7 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events in healthy volunteers with single ascending doses of IBI112
Measured: Day1 to Day 113 post dose
Secondary outcomes (5)
Maximum Concentration (Cmax) - Pharmacokinetic Assessment
IV dose \& SC dose
Measured: Day 113
Time to Maximum Concentration (Tmax) - Pharmacokinetic Assessment
SC dose
Measured: Day 113
Area Under the Curve Extrapolated to Infinity (AUC0-∞) - Pharmacokinetic Assessment
IV dose \& SC dose
Measured: Day 113
Half-Life (t1/2) - Pharmacokinetic Assessment
IV dose \& SC dose
Measured: Day 113
Volume of Distribution (Vd) - Pharmacokinetic Assessment
IV dose \& SC dose
Measured: Day 113
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start27 Aug 2020
- Primary completion22 Jul 2022
- Study completion22 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by Innovent Biologics (Suzhou) Co. Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04511624
- Sponsor's protocol ID
- CIBI112A101
- Status last verified
- Sep 2022
- First submitted
- 3 Aug 2020
- Last updated
- 19 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37358916
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04511624
- Acronym / sponsor ID
- CIBI112A101
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Aug 2020 (actual)
- Primary completion
- 22 Jul 2022 (actual)
- Study completion
- 22 Jul 2022 (actual)
- First posted
- 13 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: IBI112 dose1IBI112 SC dose1 |
| Cohort 2 | Experimental | Drug: IBI112 dose2IBI112 SC dose2 |
| Cohort 3 | Experimental | Drug: IBI112 dose3IBI112 SC dose3 |
| Cohort 4 | Experimental | Drug: IBI112 dose4IBI112 IV dose4 |
| Cohort 5 | Experimental | Drug: IBI112 dose5IBI112 IV dose3 |
| Cohort 6 | Experimental | Drug: IBI112 dose6IBI112 SC dose5 |
| Cohort 7 | Experimental | Drug: IBI112 dose7IBI112 IV dose5 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IBI112 dose1Drug: IBI112 SC dose1 Drug:placebo | Drug | Cohort 1 |
| IBI112 dose2Drug: IBI112 SC dose2 Drug:placebo | Drug | Cohort 2 |
| IBI112 dose3Drug: IBI112 SC dose3 Drug:placebo | Drug | Cohort 3 |
| IBI112 dose4Drug: IBI112 SC dose4 Drug:placebo | Drug | Cohort 4 |
| IBI112 dose5Drug: IBI112 IV dose5 Drug:placebo | Drug | Cohort 5 |
| IBI112 dose6Drug: IBI112 SC dose6 Drug:placebo | Drug | Cohort 6 |
| IBI112 dose7Drug: IBI112 IV dose7 Drug:placebo | Drug | Cohort 7 |
Primary outcome
Incidence of treatment-emergent adverse events in healthy volunteers with single ascending doses of IBI112
Time frame: Day1 to Day 113 post dose
5 secondary outcomes
Maximum Concentration (Cmax) - Pharmacokinetic Assessment
Time frame: Day 113
Time to Maximum Concentration (Tmax) - Pharmacokinetic Assessment
Time frame: Day 113
Area Under the Curve Extrapolated to Infinity (AUC0-∞) - Pharmacokinetic Assessment
Time frame: Day 113
Half-Life (t1/2) - Pharmacokinetic Assessment
Time frame: Day 113
Volume of Distribution (Vd) - Pharmacokinetic Assessment
Time frame: Day 113
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2022.
- Derived from this study: PubMed 37358916He 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IBI112 dose1, IBI112 dose2 and IBI112 dose3 in people with Healthy Subjects, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events in healthy volunteers with single ascending doses of IBI112 (time frame: Day1 to Day 113 post dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04511624, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2022.