A Study of IBI3042 in Healthy Adult Participants

NCT07842393 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: CIBI3042A102
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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. 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)

Keywords

Glucagon-Like Peptide 1 Receptor Agonists; Healthy Volunteers; Phase 1 Clinical Trials; Pharmacokinetics; Safety

Outcome Measures

Primary Outcomes (22)

• Number of Participants With Adverse Events

  Number of Participants With Adverse Events.

  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

  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).

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  through study completion, an average of 29 days

Secondary Outcomes (6)

• Area Under the Plasma Concentration Time Curve (AUC)

  through study completion, an average of 29 days

• Peak Plasma Concentration (Cmax)

  through study completion, an average of 29 days

• Time to Reach Peak Plasma Concentration (Tmax)

  through study completion, an average of 29 days

• Apparent Clearance (CL/F)

  through study completion, an average of 29 days

• Apparent Volume of Distribution (Vz/F)

  through study completion, an average of 29 days

Study Arms (2)

Matching Placebo

PLACEBO COMPARATOR

Oral, matching to IBI3042, corresponding dose regimen according to study cohort

Drug: Matching Placebo

Investigational Drug: IBI3042

EXPERIMENTAL

Oral, corresponding dose regimen according to study cohort

Drug: Investigational Drug: IBI3042

Interventions

Investigational Drug: IBI3042 DRUG

Oral, corresponding dose regimen according to study cohort

Investigational Drug: IBI3042

Matching Placebo DRUG

Oral, matching to IBI3042, corresponding dose regimen according to study cohort

Matching Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Fortvita Biologics (USA)Inc.: lead

Study Sites (1)

ICON Lenexa

Lenexa, Kansas, 66219, United States

Location

Central Study Contacts

Dee Li

CONTACT

+86 18017984650; dee.li@innoventbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2026
• First Posted: September 25, 2026
• Study Start: September 29, 2026
• Primary Completion (Estimated): February 3, 2027
• Study Completion (Estimated): February 3, 2027
• Last Updated: September 25, 2026

Record last verified: 2026-09

Locations

US (1)