Healthy ParticipantsPhase 1NCT07456839
A Mutiple-dose Study of IBI3033 in Healthy Participants
A Phase 1 study testing IBI3033 in people with Healthy Participants, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
This is a Phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of IBI3033 in Chinese healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- IBI3033
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteChina
- Study dates
- 18 Mar 2026to 13 Nov 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males/females aged 18-55 years (inclusive).
- BMI 18.0-28.0 kg/m²; weight ≥50 kg (male) or ≥45 kg (female).
- Willing to use effective contraception for 6 months post-dosing.
Who cannot join
- History of blood or needle sickness, or those who cannot tolerate venipuncture.
- Female participants who are pregnant or breastfeeding at screening or randomization.
- History of severe infection or significant injury within 6 months, or surgery within 3 months, or any infection requiring systemic medication within 1 month prior to screening.
- History of live or attenuated vaccination within 1 month prior to screening, or those who plan to be vaccinated during the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Mutiple-dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of IBI3033 in Healthy Participants
This is a Phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of IBI3033 in Chinese healthy participants. The entire trial cycle includes a 4-week screening period, 8-week treatment period and 8-week follow-up period.
- Conditions
- Healthy Participants
- Being tested
- Placebo, IBI3033
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Participants in placebo group will receive placebo SC.
IBI3033Drug
Participants in IBI3033 group will receive multiple doses of IBI3033 SC at the protocol specified dose level and time points.
| Study group | Role | What they receive |
|---|---|---|
| Placebo SC | Placebo comparator | Participants in placebo group will receive placebo SC. Receives: Drug: Placebo |
| IBI3033 Dose 2 SC | Experimental | Participants in IBI3033 group will receive multiple doses of IBI3033 SC at the protocol specified dose level and time points. Receives: Drug: IBI3033 |
| IBI3033 Dose 1 subcutaneously (SC) | Experimental | Participants in IBI3033 group will receive multiple doses of IBI3033 SC at the protocol specified dose level and time points. Receives: Drug: IBI3033 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs)/serious adverse events (SAEs)
Percentage of participants who have experienced AEs/SAEs
Measured: Baseline to Day 113
Secondary outcomes (4)
PK parameter: Cmax
Observed maximum plasma concentration of IBI3033
Measured: Baseline to Day 113
PK parameter: tmax
Time to achieve Cmax of IBI3033
Measured: Baseline to Day 113
PK parameter: AUC
Area under the plasma concentration-time curve of IBI3033
Measured: Baseline to Day 113
Immunogenticity profiles
Frequency of anti-drug antibody (ADA) of IBI3033
Measured: Baseline to Day 113
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start18 Mar 2026
- Primary completion30 Sep 2026 (estimated)
- Study completion13 Nov 2026 (estimated)
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 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
- NCT07456839
- Sponsor's protocol ID
- CIBI3033A102
- Status last verified
- May 2026
- First submitted
- 27 Feb 2026
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Mutiple-dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of IBI3033 in Healthy Participants
- ClinicalTrials.gov ID
- NCT07456839
- Acronym / sponsor ID
- CIBI3033A102
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Mar 2026 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 13 Nov 2026 (estimated)
- First posted
- 9 Mar 2026 (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 Phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of IBI3033 in Chinese healthy participants. The entire trial cycle includes a 4-week screening period, 8-week treatment period and 8-week follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo SC | Placebo comparator | Drug: PlaceboParticipants in placebo group will receive placebo SC. |
| IBI3033 Dose 2 SC | Experimental | Drug: IBI3033Participants in IBI3033 group will receive multiple doses of IBI3033 SC at the protocol specified dose level and time points. |
| IBI3033 Dose 1 subcutaneously (SC) | Experimental | Drug: IBI3033Participants in IBI3033 group will receive multiple doses of IBI3033 SC at the protocol specified dose level and time points. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy males/females aged 18-55 years (inclusive).
- BMI 18.0-28.0 kg/m²; weight ≥50 kg (male) or ≥45 kg (female).
- Willing to use effective contraception for 6 months post-dosing.
Key exclusion criteria (4 listed)
- History of blood or needle sickness, or those who cannot tolerate venipuncture.
- Female participants who are pregnant or breastfeeding at screening or randomization.
- History of severe infection or significant injury within 6 months, or surgery within 3 months, or any infection requiring systemic medication within 1 month prior to screening.
- History of live or attenuated vaccination within 1 month prior to screening, or those who plan to be vaccinated during the study.
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 |
|---|---|---|
| PlaceboParticipants in placebo group will receive placebo SC. | Drug | Placebo SC |
| IBI3033Participants in IBI3033 group will receive multiple doses of IBI3033 SC at the protocol specified dose level and time points. | Drug | IBI3033 Dose 1 subcutaneously (SC), IBI3033 Dose 2 SC |
Primary outcome
Incidence of adverse events (AEs)/serious adverse events (SAEs)
Time frame: Baseline to Day 113
Percentage of participants who have experienced AEs/SAEs
4 secondary outcomes
PK parameter: Cmax
Time frame: Baseline to Day 113
PK parameter: tmax
Time frame: Baseline to Day 113
PK parameter: AUC
Time frame: Baseline to Day 113
Immunogenticity profiles
Time frame: Baseline to Day 113
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
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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 IBI3033 in people with Healthy Participants, 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 4 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: under way, not looking for participants, as of the sponsor's last update on 26 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
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 adverse events (AEs)/serious adverse events (SAEs) (time frame: Baseline to Day 113). 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 26 May 2026.