Healthy ParticipantsPhase 1NCT06193434
A First In Human (FIH) Study of IBI356 in Healthy Participants and in Atopic Dermatitis Patients
A Phase 1 study testing IBI356 for MAD, Dupilumab for MAD and IBI356 for SAD in people with Healthy Participants and Atopic Dermatitis Patients, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of IBI356 in Healthy Participants and in Atopic Dermatitis Patients Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants, Atopic Dermatitis Patients
- What is being tested?
- IBI356 for MAD, Dupilumab for MAD and IBI356 for SAD
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 1 siteChina
- Study dates
- 5 Jan 2024to 20 Aug 2025
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy participants:
- Aged 18 to 45 years,
- Weight 50 to 120 kgs,
- Good physical and mental health based on medical history, physical examination, clinical laboratory, ECG, and vital signs, as judged by the Investigator.
- No child-bearing potential during the trial and within 6 months after SAD doses, and adequate contraceptive measures can be taken.
- Atopic dermatitis:
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- Aged 18 to 75 years,
- body mass index (BMI): 18.0 - 32.0 kg/m2,
- Atopic Dermatitis (AD) for 1 year or longer at Baseline,
- Eczema Area and Severity Index (EASI) of 16 or higher at baseline,
- Investigator Global Assessment (IGA) of 3 or 4 at baseline,
- AD involvement of 10 percent or more of body surface area at Baseline,
- Documented history, within 1 year before Baseline, of either inadequate response to topical treatments or inadvisability of topical treatments,
- Must have applied a stable dose of topical bland emollient at least twice daily for at least 7 consecutive days before Baseline.
Who cannot join
- History of relevant drug allergies.
- Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (for example, compromise the well-being) of the participant or that could prevent, limit, or confound the protocol-specified assessments
- Healthy participants:
- History of alcohol abuse or drug addiction within 1 year before screen,
- Positive drug and alcohol screen at screening.
- Atopic dermatitis:
- Having used any of the following treatments within 4 weeks before the baseline visit, or any condition that, in the opinion of the investigator, was likely to require Immunosuppressive/ immunomodulating drugs treatment(s) during the first 4 weeks of study treatment:
- Treatment with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) within 1 week before the baseline visit.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Skin Disease Hospital
Shanghai, Shanghai Municipality, 200443
About this study
Official title: A Phase 1 FIH, Randomized, Double Blind, Placebo Controlled, SAD/MAD Study to Assess Safety, Tolerability and PK in Healthy Participants and in Atopic Dermatitis Patients
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of IBI356 in Healthy Participants and in Atopic Dermatitis Patients
- Conditions
- Healthy Participants, Atopic Dermatitis Patients
- Being tested
- IBI356 for MAD, Dupilumab for MAD, IBI356 for SAD, Placebo for SAD, Placebo for MAD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI356 for MADDrug
Receive IBI356 in a multiple dose.
Dupilumab for MADDrug
Active comparator
IBI356 for SADDrug
Receive IBI356 in a single dose.
Placebo for SADDrug
Receive placebo in a single dose.
Placebo for MADDrug
Receive placebo in a multiple dose.
| Study group | Role | What they receive |
|---|---|---|
| IBI356 for Single ascending dose (SAD) | Experimental | Not described Receives: Drug: IBI356 for SAD |
| IBI356 for Multiple ascending dose (MAD) | Experimental | Not described Receives: Drug: IBI356 for MAD |
| Placebo for MAD | Placebo comparator | Not described Receives: Drug: Placebo for MAD |
| Dupilumab for MAD | Active comparator | Not described Receives: Drug: Dupilumab for MAD |
| Placebo for SAD | Placebo comparator | Not described Receives: Drug: Placebo for SAD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Adverse Event (AE) in SAD study.
Measured: Baseline to Week 20
Occurrence of Adverse Event (AE) in MAD study.
Measured: Baseline to Week 36
Occurrence of Serious Adverse Event (SAE) in SAD study.
Measured: Baseline to Week 20
Occurrence of Serious Adverse Event (SAE) in MAD study.
Measured: Baseline to Week 36
Changes in blood pressure mmHg (as a measure of safety and tolerability) in SAD study.
Measured: Baseline to Week 20
Changes in blood pressure mmHg (as a measure of safety and tolerability) in MAD study.
Measured: Baseline to Week 36
Changes in respiratory rate measured as breaths per minute (as a measure of safety and tolerability) in SAD study.
Measured: Baseline to Week 20
Changes in respiratory rate measured as breaths per minute (as a measure of safety and tolerability) in MAD study.
Measured: Baseline to Week 36
Changes in heart rate bpm (as a measure of safety and tolerability) in SAD study.
Measured: Baseline to Week 20
Changes in heart rate bpm (as a measure of safety and tolerability) in MAD study.
Measured: Baseline to Week 36
Changes in tympanic temperature °C in SAD study.
Measured: Baseline to Week 20
Changes in tympanic temperature °C in MAD study.
Measured: Baseline to Week 36
Changes in electrocardiograms PR, QR, QRS and QT intervals (as a measure of safety and tolerability) in SAD study.
Measured: Baseline to Week 20
Changes in electrocardiograms PR, QR, QRS and QT intervals (as a measure of safety and tolerability) in MAD study.
Measured: Baseline to Week 36
Secondary outcomes (6)
Area under the concentration time curve from time 0 to last observation (AUC 0-t).
Measured: Baseline to Week 16
Maximum observed concentration (Cmax) after infusion.
Measured: Baseline to Week 16
Systemic clearance after infusion (CL).
Measured: Baseline to Week 16
Volume of distribution during the terminal phase after infusion(Apparent volume of distribution, V).
Measured: Baseline to Week 16
Elimination half-life during the terminal phase after infusion(Half-life, t1/2).
Measured: Baseline to Week 16
To assess immunogenicity: production of anti-drug antibodies (ADA) following SAD and Multiple ascending dose(MAD) doses.
Measured: Baseline to Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start5 Jan 2024
- Primary completion20 Aug 2025
- Study completion20 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 99 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
- NCT06193434
- Sponsor's protocol ID
- CIBI356A101CN
- Status last verified
- Aug 2025
- First submitted
- 12 Dec 2023
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 FIH, Randomized, Double Blind, Placebo Controlled, SAD/MAD Study to Assess Safety, Tolerability and PK in Healthy Participants and in Atopic Dermatitis Patients
- ClinicalTrials.gov ID
- NCT06193434
- Acronym / sponsor ID
- CIBI356A101CN
- Conditions
- Healthy Participants, Atopic Dermatitis Patients
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Jan 2024 (actual)
- Primary completion
- 20 Aug 2025 (actual)
- Study completion
- 20 Aug 2025 (actual)
- First posted
- 5 Jan 2024 (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.
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of IBI356 in Healthy Participants and in Atopic Dermatitis Patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| IBI356 for Single ascending dose (SAD) | Experimental | Drug: IBI356 for SAD |
| IBI356 for Multiple ascending dose (MAD) | Experimental | Drug: IBI356 for MAD |
| Placebo for MAD | Placebo comparator | Drug: Placebo for MAD |
| Dupilumab for MAD | Active comparator | Drug: Dupilumab for MAD |
| Placebo for SAD | Placebo comparator | Drug: Placebo for SAD |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Healthy participants:
- Atopic dermatitis:
Key exclusion criteria (8 listed)
- History of relevant drug allergies.
- Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (for example, compromise the well-being) of the participant or that could prevent, limit, or confound the protocol-specified assessments
- Healthy participants:
- Atopic dermatitis:
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 |
|---|---|---|
| IBI356 for MADReceive IBI356 in a multiple dose. | Drug | IBI356 for Multiple ascending dose (MAD) |
| Dupilumab for MADActive comparator | Drug | Dupilumab for MAD |
| IBI356 for SADReceive IBI356 in a single dose. | Drug | IBI356 for Single ascending dose (SAD) |
| Placebo for SADReceive placebo in a single dose. | Drug | Placebo for SAD |
| Placebo for MADReceive placebo in a multiple dose. | Drug | Placebo for MAD |
Primary outcome
Occurrence of Adverse Event (AE) in SAD study.
Time frame: Baseline to Week 20
Occurrence of Adverse Event (AE) in MAD study.
Time frame: Baseline to Week 36
Occurrence of Serious Adverse Event (SAE) in SAD study.
Time frame: Baseline to Week 20
Occurrence of Serious Adverse Event (SAE) in MAD study.
Time frame: Baseline to Week 36
Changes in blood pressure mmHg (as a measure of safety and tolerability) in SAD study.
Time frame: Baseline to Week 20
Changes in blood pressure mmHg (as a measure of safety and tolerability) in MAD study.
Time frame: Baseline to Week 36
Changes in respiratory rate measured as breaths per minute (as a measure of safety and tolerability) in SAD study.
Time frame: Baseline to Week 20
Changes in respiratory rate measured as breaths per minute (as a measure of safety and tolerability) in MAD study.
Time frame: Baseline to Week 36
Changes in heart rate bpm (as a measure of safety and tolerability) in SAD study.
Time frame: Baseline to Week 20
Changes in heart rate bpm (as a measure of safety and tolerability) in MAD study.
Time frame: Baseline to Week 36
Changes in tympanic temperature °C in SAD study.
Time frame: Baseline to Week 20
Changes in tympanic temperature °C in MAD study.
Time frame: Baseline to Week 36
Changes in electrocardiograms PR, QR, QRS and QT intervals (as a measure of safety and tolerability) in SAD study.
Time frame: Baseline to Week 20
Changes in electrocardiograms PR, QR, QRS and QT intervals (as a measure of safety and tolerability) in MAD study.
Time frame: Baseline to Week 36
6 secondary outcomes
Area under the concentration time curve from time 0 to last observation (AUC 0-t).
Time frame: Baseline to Week 16
Maximum observed concentration (Cmax) after infusion.
Time frame: Baseline to Week 16
Systemic clearance after infusion (CL).
Time frame: Baseline to Week 16
Volume of distribution during the terminal phase after infusion(Apparent volume of distribution, V).
Time frame: Baseline to Week 16
Elimination half-life during the terminal phase after infusion(Half-life, t1/2).
Time frame: Baseline to Week 16
To assess immunogenicity: production of anti-drug antibodies (ADA) following SAD and Multiple ascending dose(MAD) doses.
Time frame: Baseline to Week 16
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 2 Sep 2025.
- Individual participant dataSharing planned: No
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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 IBI356 for MAD, Dupilumab for MAD and IBI356 for SAD in people with Healthy Participants and Atopic Dermatitis Patients, 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 14 inclusion and 8 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 2 Sep 2025. 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. Some participants in this study may receive a placebo. 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?
Occurrence of Adverse Event (AE) in SAD study. (time frame: Baseline to Week 20). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Sep 2025.