Healthy Volunteers (HV)Phase 1NCT07842393
A Study of IBI3042 in Healthy Adult Participants
A Phase 1 study testing Investigational Drug: IBI3042 in people with Healthy Volunteers (HV), run by Fortvita Biologics (USA)Inc. at 1 site in United States.
Trial summary
This is a randomized, investigator- and participant-blinded, placebo-controlled, parallel-group, dose-escalation Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of single ascending oral doses of IBI3042, in healthy adult 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 Volunteers (HV)
- What is being tested?
- Investigational Drug: IBI3042
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2026to 3 Feb 2027
- 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
- Aged 18 to 55 years, inclusive.
- BMI ≥20 and <32 kg/m² and body weight ≥50 kg;
- Female participants of childbearing potential and male participants with female partners of childbearing potential must agree to use highly effective contraception during the study and for 90 days after the last dose.
- Able and willing to comply with study procedures and voluntarily provide written informed consent.
Who cannot join
- Known or suspected hypersensitivity to any component of the study drug or to GLP-1 receptor agonists.
- History of diabetes or abnormal glycemic parameters at screening.
- Personal or family history of thyroid C-cell carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN 2A or 2B), or calcitonin ≥20 ng/L at screening.
- History of acute or chronic pancreatitis, or clinically significant pancreatic enzyme elevation at screening.
- Use of medications that may significantly affect gastrointestinal motility, appetite, or drug absorption within 3 months prior to screening.
- Clinically significant hematologic, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurologic disease that may increase study-related risk or interfere with study assessments.
Show all 11Show fewer
- Clinically significant abnormalities in physical examination or laboratory tests at screening.
- History of malignancy within 5 years, except for basal cell or squamous cell skin cancer.
- Use of prescription or over-the-counter medications, or dietary supplement vitamins within 2 weeks or 5 half-lives, whichever is greater, prior to screening; or use of any herbal products within 4 weeks prior to screening.
- Participation in another drug or medical device clinical study within 3 months prior to screening or within 5 half-lives of the investigational drug, as applicable.
- Any other condition that, in the investigator's opinion, makes the participant unsuitable for participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
ICON Lenexa
Lenexa, Kansas, 66219
Pactrick Yao, +1 913 574 6457, Patrick.Yao@iconplc.com
Pactrick Yao, PhD
About this study
Official title: A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of IBI3042 in Healthy Adult Participants
This is a randomized, investigator- and participant-blinded, placebo-controlled, parallel-group, dose-escalation Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of single ascending oral doses of IBI3042, in healthy adult participants. Approximately 32 healthy participants will be enrolled across 4 single ascending dose groups, with 8 participants per group randomized in a 6:2 ratio to receive a single oral dose of IBI3042 or matching placebo. A sentinel-dosing design is used for the first dose cohort. Safety and PK data are assessed to support dose escalation decisions by the Safety Review Committee.
- Conditions
- Healthy Volunteers (HV)
- Being tested
- Investigational Drug: IBI3042, Matching Placebo
- Keywords
- Glucagon-Like Peptide 1 Receptor Agonists, Healthy Volunteers, Phase 1 Clinical Trials, Pharmacokinetics, Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational Drug: IBI3042Drug
Oral, corresponding dose regimen according to study cohort
Matching PlaceboDrug
Oral, matching to IBI3042, corresponding dose regimen according to study cohort
| Study group | Role | What they receive |
|---|---|---|
| Matching Placebo | Placebo comparator | Oral, matching to IBI3042, corresponding dose regimen according to study cohort Receives: Drug: Matching Placebo |
| Investigational Drug: IBI3042 | Experimental | Oral, corresponding dose regimen according to study cohort Receives: Drug: Investigational Drug: IBI3042 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events
Number of Participants With Adverse Events.
Measured: through study completion, an average of 29 days
Number of Participants With Clinically Significant Abnormal Vital Signs
Number of Participants With Clinically Significant Abnormal Vital Signs
Measured: through study completion, an average of 29 days
Number of Participants With Clinically Significant Abnormal 12-lead electrocardiogram
Number of participants with at least one clinically significant abnormal finding on resting 12-lead electrocardiogram(ECG). Participants shall lie supine for at least 5 minutes prior to ECG acquisition and remain supine during ECGrecording. Evaluated ECG parameters include RR interval, PR interval, heart rate, QT interval, and QTcF(QTcF=QT/RR^0.33).
Measured: through study completion, an average of 29 days
Number of Participants With Abnormal General Appearance Findings
Number of participants with at least one clinically significant abnormal finding in general appearance on physical examination.
Measured: through study completion, an average of 29 days
Number of Participants With Abnormal Respiratory Findings
Number of participants with at least one clinically significant abnormal finding in respiratory tract assessment on physical examination.
Measured: through study completion, an average of 29 days
Number of Participants With Abnormal Cardiovascular Findings
Number of participants with at least one clinically significant abnormal finding in cardiovascular assessment on physical examination.
Measured: through study completion, an average of 29 days
Number of Participants With Abnormal Abdominal Findings
Number of participants with at least one clinically significant abnormal finding in abdominal assessment on physical examination.
Measured: through study completion, an average of 29 days
Number of Participants With Abnormal Skin Findings
Number of participants with at least one clinically significant abnormal finding in skin assessment on physical examination.
Measured: through study completion, an average of 29 days
Number of Participants With Abnormal Head and Neck Findings
Number of participants with at least one clinically significant abnormal finding in head and neck (ear, eye, nose, throat) assessment on physical examination.
Measured: through study completion, an average of 29 days
Number of Participants With Abnormal Lymph Node Findings
Number of participants with at least one clinically significant abnormal finding in lymph node assessment on physical examination.
Measured: through study completion, an average of 29 days
Number of Participants With Abnormal Thyroid Findings
Number of participants with at least one clinically significant abnormal finding in thyroid assessment on physical examination.
Measured: through study completion, an average of 29 days
Number of Participants With Abnormal Musculoskeletal Findings
Number of participants with at least one clinically significant abnormal finding in musculoskeletal (spine and extremities) assessment on physical examination.
Measured: through study completion, an average of 29 days
Number of Participants With Abnormal Neurological Findings
Number of participants with at least one clinically significant abnormal finding in neurological assessment on physical examination.
Measured: through study completion, an average of 29 days
Number of Participants With Abnormal Blood Routine Findings
Number of participants with at least one clinically significant abnormal finding in blood routine tests.
Measured: through study completion, an average of 29 days
Number of Participants With Abnormal Blood Biochemistry Findings
Number of participants with at least one clinically significant abnormal finding in blood biochemistry tests, including blood lipids.
Measured: through study completion, an average of 29 days
Number of Participants With Abnormal Coagulation Findings
Number of participants with at least one clinically significant abnormal finding in coagulation routine tests.
Measured: through study completion, an average of 29 days
Number of Participants With Abnormal Urine Routine Findings
Number of participants with at least one clinically significant abnormal finding in urine routine tests.
Measured: through study completion, an average of 29 days
Number of Participants With Abnormal Calcitonin Findings
Number of participants with at least one clinically significant abnormal finding in calcitonin test.
Measured: through study completion, an average of 29 days
Number of Participants With Abnormal Glycated Hemoglobin Findings
Number of participants with at least one clinically significant abnormal finding in glycated hemoglobin (HbA1c) test.
Measured: through study completion, an average of 29 days
Number of Participants With Abnormal Infection-Related Immunology Findings
Number of participants with at least one clinically significant abnormal finding in infection-related immunology tests.
Measured: through study completion, an average of 29 days
Number of Participants With Abnormal Thyroid Function Findings
Number of participants with at least one clinically significant abnormal finding in thyroid function tests.
Measured: through study completion, an average of 29 days
Number of Participants With Abnormal Pregnancy Test Findings
Number of participants with at least one clinically significant abnormal finding in pregnancy test.
Measured: through study completion, an average of 29 days
Secondary outcomes (6)
Area Under the Plasma Concentration Time Curve (AUC)
Measured: through study completion, an average of 29 days
Peak Plasma Concentration (Cmax)
Measured: through study completion, an average of 29 days
Time to Reach Peak Plasma Concentration (Tmax)
Measured: through study completion, an average of 29 days
Apparent Clearance (CL/F)
Measured: through study completion, an average of 29 days
Apparent Volume of Distribution (Vz/F)
Measured: through study completion, an average of 29 days
Terminal Half-Life (T1/2)
Measured: through study completion, an average of 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start29 Sep 2026 (estimated)
- Primary completion3 Feb 2027 (estimated)
- Study completion3 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteers (HV)Studies 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fortvita Biologics (USA)Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07842393
- Sponsor's protocol ID
- CIBI3042A102
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of IBI3042 in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT07842393
- Acronym / sponsor ID
- CIBI3042A102
- Conditions
- Healthy Volunteers (HV)
- Keywords
- Glucagon-Like Peptide 1 Receptor Agonists, Healthy Volunteers, Phase 1 Clinical Trials, Pharmacokinetics, Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Fortvita Biologics (USA)Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Sep 2026 (estimated)
- Primary completion
- 3 Feb 2027 (estimated)
- Study completion
- 3 Feb 2027 (estimated)
- First posted
- 25 Sep 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 randomized, investigator- and participant-blinded, placebo-controlled, parallel-group, dose-escalation Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of single ascending oral doses of IBI3042, in healthy adult participants. Approximately 32 healthy participants will be enrolled across 4 single ascending dose groups, with 8 participants per group randomized in a 6:2 ratio to receive a single oral dose of IBI3042 or matching placebo. A sentinel-dosing design is used for the first dose cohort. Safety and PK data are assessed to support dose escalation decisions by the Safety Review Committee.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Matching Placebo | Placebo comparator | Drug: Matching PlaceboOral, matching to IBI3042, corresponding dose regimen according to study cohort |
| Investigational Drug: IBI3042 | Experimental | Drug: Investigational Drug: IBI3042Oral, corresponding dose regimen according to study cohort |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Aged 18 to 55 years, inclusive.
- BMI ≥20 and <32 kg/m² and body weight ≥50 kg;
- Female participants of childbearing potential and male participants with female partners of childbearing potential must agree to use highly effective contraception during the study and for 90 days after the last dose.
- Able and willing to comply with study procedures and voluntarily provide written informed consent.
Key exclusion criteria (11 listed)
- Known or suspected hypersensitivity to any component of the study drug or to GLP-1 receptor agonists.
- History of diabetes or abnormal glycemic parameters at screening.
- Personal or family history of thyroid C-cell carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN 2A or 2B), or calcitonin ≥20 ng/L at screening.
- History of acute or chronic pancreatitis, or clinically significant pancreatic enzyme elevation at screening.
- Use of medications that may significantly affect gastrointestinal motility, appetite, or drug absorption within 3 months prior to screening.
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 |
|---|---|---|
| Investigational Drug: IBI3042Oral, corresponding dose regimen according to study cohort | Drug | Investigational Drug: IBI3042 |
| Matching PlaceboOral, matching to IBI3042, corresponding dose regimen according to study cohort | Drug | Matching Placebo |
Primary outcome
Number of Participants With Adverse Events
Time frame: through study completion, an average of 29 days
Number of Participants With Adverse Events.
Number of Participants With Clinically Significant Abnormal Vital Signs
Time frame: through study completion, an average of 29 days
Number of Participants With Clinically Significant Abnormal Vital Signs
Number of Participants With Clinically Significant Abnormal 12-lead electrocardiogram
Time frame: through study completion, an average of 29 days
Number of participants with at least one clinically significant abnormal finding on resting 12-lead electrocardiogram(ECG). Participants shall lie supine for at least 5 minutes prior to ECG acquisition and remain supine during ECGrecording. Evaluated ECG parameters include RR interval, PR interval, heart rate, QT interval, and QTcF(QTcF=QT/RR^0.33).
Number of Participants With Abnormal General Appearance Findings
Time frame: through study completion, an average of 29 days
Number of participants with at least one clinically significant abnormal finding in general appearance on physical examination.
Number of Participants With Abnormal Respiratory Findings
Time frame: through study completion, an average of 29 days
Number of participants with at least one clinically significant abnormal finding in respiratory tract assessment on physical examination.
Number of Participants With Abnormal Cardiovascular Findings
Time frame: through study completion, an average of 29 days
Number of participants with at least one clinically significant abnormal finding in cardiovascular assessment on physical examination.
Number of Participants With Abnormal Abdominal Findings
Time frame: through study completion, an average of 29 days
Number of participants with at least one clinically significant abnormal finding in abdominal assessment on physical examination.
Number of Participants With Abnormal Skin Findings
Time frame: through study completion, an average of 29 days
Number of participants with at least one clinically significant abnormal finding in skin assessment on physical examination.
Number of Participants With Abnormal Head and Neck Findings
Time frame: through study completion, an average of 29 days
Number of participants with at least one clinically significant abnormal finding in head and neck (ear, eye, nose, throat) assessment on physical examination.
Number of Participants With Abnormal Lymph Node Findings
Time frame: through study completion, an average of 29 days
Number of participants with at least one clinically significant abnormal finding in lymph node assessment on physical examination.
Number of Participants With Abnormal Thyroid Findings
Time frame: through study completion, an average of 29 days
Number of participants with at least one clinically significant abnormal finding in thyroid assessment on physical examination.
Number of Participants With Abnormal Musculoskeletal Findings
Time frame: through study completion, an average of 29 days
Number of participants with at least one clinically significant abnormal finding in musculoskeletal (spine and extremities) assessment on physical examination.
Number of Participants With Abnormal Neurological Findings
Time frame: through study completion, an average of 29 days
Number of participants with at least one clinically significant abnormal finding in neurological assessment on physical examination.
Number of Participants With Abnormal Blood Routine Findings
Time frame: through study completion, an average of 29 days
Number of participants with at least one clinically significant abnormal finding in blood routine tests.
Number of Participants With Abnormal Blood Biochemistry Findings
Time frame: through study completion, an average of 29 days
Number of participants with at least one clinically significant abnormal finding in blood biochemistry tests, including blood lipids.
Number of Participants With Abnormal Coagulation Findings
Time frame: through study completion, an average of 29 days
Number of participants with at least one clinically significant abnormal finding in coagulation routine tests.
Number of Participants With Abnormal Urine Routine Findings
Time frame: through study completion, an average of 29 days
Number of participants with at least one clinically significant abnormal finding in urine routine tests.
Number of Participants With Abnormal Calcitonin Findings
Time frame: through study completion, an average of 29 days
Number of participants with at least one clinically significant abnormal finding in calcitonin test.
Number of Participants With Abnormal Glycated Hemoglobin Findings
Time frame: through study completion, an average of 29 days
Number of participants with at least one clinically significant abnormal finding in glycated hemoglobin (HbA1c) test.
Number of Participants With Abnormal Infection-Related Immunology Findings
Time frame: through study completion, an average of 29 days
Number of participants with at least one clinically significant abnormal finding in infection-related immunology tests.
Number of Participants With Abnormal Thyroid Function Findings
Time frame: through study completion, an average of 29 days
Number of participants with at least one clinically significant abnormal finding in thyroid function tests.
Number of Participants With Abnormal Pregnancy Test Findings
Time frame: through study completion, an average of 29 days
Number of participants with at least one clinically significant abnormal finding in pregnancy test.
6 secondary outcomes
Area Under the Plasma Concentration Time Curve (AUC)
Time frame: through study completion, an average of 29 days
Peak Plasma Concentration (Cmax)
Time frame: through study completion, an average of 29 days
Time to Reach Peak Plasma Concentration (Tmax)
Time frame: through study completion, an average of 29 days
Apparent Clearance (CL/F)
Time frame: through study completion, an average of 29 days
Apparent Volume of Distribution (Vz/F)
Time frame: through study completion, an average of 29 days
Terminal Half-Life (T1/2)
Time frame: through study completion, an average of 29 days
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 25 Sep 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.
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 Investigational Drug: IBI3042 in people with Healthy Volunteers (HV), run by Fortvita Biologics (USA)Inc. at 1 site in United States.
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 4 inclusion and 11 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: opening soon, as of the sponsor's last update on 25 Sep 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 United States. 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?
Contact Dee Li (+86 18017984650, dee.li@innoventbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (time frame: through study completion, an average of 29 days). The study lists 22 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 25 Sep 2026.