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Not yet recruiting Phase 1 Interventional Accepts healthy volunteers

A Study of IBI3042 in Healthy Adult Participants

ClinicalTrials.gov ID: NCT07842393

Public ClinicalTrials.gov record NCT07842393. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 28, 2026, 4:08 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of IBI3042 in Healthy Adult Participants

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT07842393
Recruitment status
Not yet recruiting
Study type
Interventional
Phase
Phase 1
Lead sponsor
Fortvita Biologics (USA)Inc.
Industry
Enrollment
32 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 55 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 28, 2026
Primary completion
Feb 2, 2027
Completion
Feb 2, 2027
Last update posted
Sep 24, 2026

2026 – 2027

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
ICON Lenexa Lenexa Kansas 66219 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07842393, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 24, 2026 · Synced Sep 28, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07842393 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →