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First-in-Human study launches for experimental drug ABSK061

NCT ID NCT07007546

Knowledge-focused Sponsor: Abbisko Therapeutics Co, Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 29, 2026 · Last updated Jun 30, 2026 · Updated 1 time

Summary

This Phase 1 trial evaluates the safety, tolerability, and how the body handles ABSK061, given as mini-tablets by mouth. Healthy adults aged 18 to 45 receive single or multiple doses to measure drug levels and any side effects. The study also checks whether taking the tablets with soft food changes drug absorption. Results will guide future research into potential uses of ABSK061.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ABSK061
What this could lead to
If successful, this early study could pave the way for future trials of ABSK061 as a potential treatment for certain diseases.
What could go wrong
This is a very early Phase 1 trial in only 42 healthy people, designed mainly to check safety and dosing. It does not test whether the drug works for any disease, and many early-stage drugs never advance.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

42 people

The number who actually took part.

Started

May 2025

Finished

Apr 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Gender:male or female participants, both male and female * Age: 18 to 45 years (including 18 and 45 years) * Weight: male participants weigh ≥ 50.0 kg, female participants weigh ≥ 45.0 kg, and body mass index is in the range of 19.0-26.0 kg/m2 (including cut-off value), and body mass index (BMI) = weight (kg)/height 2 (m2) * Able to understand and willing to comply with the study procedures, voluntarily participate in this clinical trial and sign the informed consent form before screening Exclusion Criteria: * Significant history of any hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, immunologic, musculoskeletal disease, or allergic disease (as determined by the Investigator) * Any ocular condition likely to increase the risk of eye toxicity * Gastrointestinal disorders that will affect oral administration or absorption of ABSK061 * Females of child-bearing potential and males who plan to father a child while enrolled in this study

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy

Contacts and locations

Locations

  • Jiangnan University Affiliated Hospital

    Wuxi, Jiangsu, 214062, China

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