A Phase 1 interventional study of Investigational Drug: IBI3042 and Matching Placebo in Healthy Volunteers (HV), sponsored by Fortvita Biologics (USA)Inc.. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Fortvita Biologics (USA)Inc. (part of Innovent Biologics, Inc.) · Phase 1, Interventional, and Treatment
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.
Fortvita Biologics (USA)Inc. is the lead sponsor of 5 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Oral, matching to IBI3042, corresponding dose regimen according to study cohort
Drug: Matching Placebo
Oral, corresponding dose regimen according to study cohort
Drug: Investigational Drug: IBI3042
Oral, corresponding dose regimen according to study cohort
Oral, matching to IBI3042, corresponding dose regimen according to study cohort
Number of Participants With Adverse Events
Number of Participants With Adverse Events.
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 Vital Signs
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: through study completion, an average of 29 days
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
Start is estimated for Sep 2026; primary completion for Feb 2027, 4 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: IBI3042
Fortvita Biologics (USA)Inc. →