HealthyEarly Phase 1NCT07134127
A Study of IBI3032 in Chinese Healthy Subjects
A Early Phase 1 study testing IBI3032 in people with Healthy, run by Innovent Biologics Technology Limited (Shanghai R&D Center) at 1 site in China.
Trial summary
This is a randomized, double-blind, placebo-controlled Phase I clinical study evaluating the safety, tolerability, PK and food effect of a single dose of IBI3032 in healthy participants. This is a single ascending dose (SAD) study. Approximately 40 healthy participants are expected to be enrolled in this study. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- IBI3032
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 29 Aug 2025to 7 Oct 2025
- Phase
- Early 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male or females, as determined by medical history
- Have safety laboratory results within normal reference ranges
Who cannot join
- Have known allergies toIBI3032， glucagon-like peptide-1 (GLP-1) analogs, related compounds
- Abnormal electrocardiogram (ECG) at screening
- Significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological or neurological disorders.
Trial locations and contacts
1 site in 1 country.
China1 site
The Frist Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230000
About this study
Official title: A Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Food Effect of IBI3032 in Participants
This is a randomized, double-blind, placebo-controlled Phase I clinical study evaluating the safety, tolerability, PK and food effect of a single dose of IBI3032 in healthy participants. This is a single ascending dose (SAD) study. Approximately 40 healthy participants are expected to be enrolled in this study. The screening period is 4 weeks. Eligible participants will be divided into 4 cohorts. Cohort1,2,4 consisted of 8 healthy participants who will be randomized in a 6:2 ratio to receive a single dose of IBI3032 or placebo. The safety follow-up period is 15 days. Cohort 3 consisted of 16 participants used a two-cycle, double-crossover design, who were randomly divided into four groups at a ratio of 3:1:3:1: Cohort 3-1-IBI3032, cohort 3-1-placebo, cohort 3-2-IBI3032, and cohort 3-2-placebo, each subject underwent two cycles of the trial. In cohort 3-1, the first cycle was given on fasted administration, and the second cycle was given after breakfast. In cohort 3-2, the first cycle was administered after breakfast intake, and the second cycle was administered fasted. The washout period for cohort 3-1 and cohort 3-2 was 8 days.
- Conditions
- Healthy
- Being tested
- placebo, IBI3032
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
Placebo (without active ingredients) (cohort1, 2,4) Method of administration: oral, fasted administration. Placebo (without active ingredients) (cohort3) Method of administration: oral, administration after meal.
IBI3032Drug
IBI3032: (cohort1, 2,4) Method of administration: oral, fasted administration. IBI3032: (cohort3) Method of administration: oral, administration after meal.
| Study group | Role | What they receive |
|---|---|---|
| Single dose1 of IBI3032 administered orally. | Experimental | dose1 IBI3032 Receives: Drug: IBI3032 |
| Single dose4 of placebo administered orally. | Placebo comparator | dose4 placebo Receives: Drug: placebo |
| Single dose4 of IBI3032 administered orally. | Experimental | dose4 IBI3032 Receives: Drug: IBI3032 |
| D1:Single dose3-1 of placebo administered orally. D9:Single dose3-1 of placebo administered orally. | Active comparator | D1: Fasted administer D9:Administer after meal Receives: Drug: placebo |
| Single dose2 of IBI3032 administered orally. | Experimental | dose2 IBI3032 Receives: Drug: IBI3032 |
| D1:Single dose3-2 of placebo administered orally. D9:Single dose3-2 of placebo administered orally. | Active comparator | D1:Administer after meal D9: Fasted administer Receives: Drug: placebo |
| D1:Single dose3-2 of IBI3032 administered orally. D9:Single dose3-2 of IBI3032 administered orally. | Experimental | D1:Administer after meal D9: Fasted administer Receives: Drug: IBI3032 |
| D1:Single dose3-1 of IBI3032 administered orally. D9:Single dose3-1 of IBI3032 administered orally. | Experimental | D1: Fasted administer D9:Administer after meal Receives: Drug: IBI3032 |
| Single dose1 of placebo administered orally. | Placebo comparator | dose1 placebo Receives: Drug: placebo |
| Single dose2 of placebo administered orally. | Placebo comparator | dose2 placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with One Serious Adverse Event(s) Considered by the Investigator to be Related to Study Drug
A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module
Measured: (Cohoet1,2,4) Baseline up to Day 15 (Cohoet3) Baseline up to Day 15
Number of Participants with More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug
A summary of other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Measured: (Cohoet1,2,4) Baseline up to Day 15 (Cohoet3) Baseline up to Day 15
Number of Participants with adverse events (AEs)
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.
Measured: (Cohoet1,2,4) Baseline up to Day 15 (Cohoet3) Baseline up to Day 15
Secondary outcomes (6)
Under the Serum Concentration-time Curve (AUC) of IBI3032
To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants.
Measured: Predose up to 168 hours postdose
maximum concentration (Cmax) of IBI3032
To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants.
Measured: Predose up to 168 hours postdose
time to maximum concentration (Tmax) of IBI3032
To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants.
Measured: Predose up to 168 hours postdose
clearance (CL) of IBI3032
To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants.
Measured: Predose up to 168 hours postdose
apparent volume of distribution (V) of IBI3032
To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants.
Measured: Predose up to 168 hours postdose
elimination half-life (T1/2) of IBI3032
To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants.
Measured: Predose up to 168 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start29 Aug 2025
- Primary completion7 Oct 2025
- Study completion7 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics Technology Limited (Shanghai R&D Center)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07134127
- Sponsor's protocol ID
- CIBI3032T001
- Status last verified
- Nov 2025
- First submitted
- 14 Aug 2025
- Last updated
- 17 Nov 2025
- 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 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Food Effect of IBI3032 in Participants
- ClinicalTrials.gov ID
- NCT07134127
- Acronym / sponsor ID
- CIBI3032T001
- Conditions
- Healthy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Innovent Biologics Technology Limited (Shanghai R&D Center)Industry (pharma, biotech, devices)
- Study start
- 29 Aug 2025 (actual)
- Primary completion
- 7 Oct 2025 (actual)
- Study completion
- 7 Oct 2025 (actual)
- First posted
- 21 Aug 2025 (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 randomized, double-blind, placebo-controlled Phase I clinical study evaluating the safety, tolerability, PK and food effect of a single dose of IBI3032 in healthy participants. This is a single ascending dose (SAD) study. Approximately 40 healthy participants are expected to be enrolled in this study. The screening period is 4 weeks. Eligible participants will be divided into 4 cohorts. Cohort1,2,4 consisted of 8 healthy participants who will be randomized in a 6:2 ratio to receive a single dose of IBI3032 or placebo. The safety follow-up period is 15 days. Cohort 3 consisted of 16 participants used a two-cycle, double-crossover design, who were randomly divided into four groups at a ratio of 3:1:3:1: Cohort 3-1-IBI3032, cohort 3-1-placebo, cohort 3-2-IBI3032, and cohort 3-2-placebo, each subject underwent two cycles of the trial. In cohort 3-1, the first cycle was given on fasted administration, and the second cycle was given after breakfast. In cohort 3-2, the first cycle was administered after breakfast intake, and the second cycle was administered fasted. The washout period for cohort 3-1 and cohort 3-2 was 8 days.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Single dose1 of IBI3032 administered orally. | Experimental | Drug: IBI3032dose1 IBI3032 |
| Single dose4 of placebo administered orally. | Placebo comparator | Drug: placebodose4 placebo |
| Single dose4 of IBI3032 administered orally. | Experimental | Drug: IBI3032dose4 IBI3032 |
| D1:Single dose3-1 of placebo administered orally. D9:Single dose3-1 of placebo administered orally. | Active comparator | Drug: placeboD1: Fasted administer D9:Administer after meal |
| Single dose2 of IBI3032 administered orally. | Experimental | Drug: IBI3032dose2 IBI3032 |
| D1:Single dose3-2 of placebo administered orally. D9:Single dose3-2 of placebo administered orally. | Active comparator | Drug: placeboD1:Administer after meal D9: Fasted administer |
| D1:Single dose3-2 of IBI3032 administered orally. D9:Single dose3-2 of IBI3032 administered orally. | Experimental | Drug: IBI3032D1:Administer after meal D9: Fasted administer |
| D1:Single dose3-1 of IBI3032 administered orally. D9:Single dose3-1 of IBI3032 administered orally. | Experimental | Drug: IBI3032D1: Fasted administer D9:Administer after meal |
| Single dose1 of placebo administered orally. | Placebo comparator | Drug: placebodose1 placebo |
| Single dose2 of placebo administered orally. | Placebo comparator | Drug: placebodose2 placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy male or females, as determined by medical history
- Have safety laboratory results within normal reference ranges
Key exclusion criteria (3 listed)
- Have known allergies toIBI3032， glucagon-like peptide-1 (GLP-1) analogs, related compounds
- Abnormal electrocardiogram (ECG) at screening
- Significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological or neurological disorders.
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 |
|---|---|---|
| placeboPlacebo (without active ingredients) (cohort1, 2,4) Method of administration: oral, fasted administration. Placebo (without active ingredients) (cohort3) Method of administration: oral, administration after meal. | Drug | D1:Single dose3-1 of placebo administered orally. D9:Single dose3-1 of placebo administered orally., D1:Single dose3-2 of placebo administered orally. D9:Single dose3-2 of placebo administered orally., Single dose1 of placebo administered orally., Single dose2 of placebo administered orally., Single dose4 of placebo administered orally. |
| IBI3032IBI3032: (cohort1, 2,4) Method of administration: oral, fasted administration. IBI3032: (cohort3) Method of administration: oral, administration after meal. | Drug | D1:Single dose3-1 of IBI3032 administered orally. D9:Single dose3-1 of IBI3032 administered orally., D1:Single dose3-2 of IBI3032 administered orally. D9:Single dose3-2 of IBI3032 administered orally., Single dose1 of IBI3032 administered orally., Single dose2 of IBI3032 administered orally., Single dose4 of IBI3032 administered orally. |
Primary outcome
Number of Participants with One Serious Adverse Event(s) Considered by the Investigator to be Related to Study Drug
Time frame: (Cohoet1,2,4) Baseline up to Day 15 (Cohoet3) Baseline up to Day 15
A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module
Number of Participants with More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug
Time frame: (Cohoet1,2,4) Baseline up to Day 15 (Cohoet3) Baseline up to Day 15
A summary of other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Number of Participants with adverse events (AEs)
Time frame: (Cohoet1,2,4) Baseline up to Day 15 (Cohoet3) Baseline up to Day 15
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.
6 secondary outcomes
Under the Serum Concentration-time Curve (AUC) of IBI3032
Time frame: Predose up to 168 hours postdose
maximum concentration (Cmax) of IBI3032
Time frame: Predose up to 168 hours postdose
time to maximum concentration (Tmax) of IBI3032
Time frame: Predose up to 168 hours postdose
clearance (CL) of IBI3032
Time frame: Predose up to 168 hours postdose
apparent volume of distribution (V) of IBI3032
Time frame: Predose up to 168 hours postdose
elimination half-life (T1/2) of IBI3032
Time frame: Predose up to 168 hours postdose
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 17 Nov 2025.
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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 Early Phase 1 study testing IBI3032 in people with Healthy, run by Innovent Biologics Technology Limited (Shanghai R&D Center) 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 2 inclusion and 3 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 17 Nov 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Number of Participants with One Serious Adverse Event(s) Considered by the Investigator to be Related to Study Drug (time frame: (Cohoet1,2,4) Baseline up to Day 15 (Cohoet3) Baseline up to Day 15). The study lists 3 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 17 Nov 2025.