HealthyPhase 1NCT07007546
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ABSK061 Mini-tablets in Healthy Adult Participants
A Phase 1 study testing ABSK061 in people with Healthy, run by Abbisko Therapeutics Co, Ltd at 1 site in China.
Trial summary
To main objective is to evaluate the safety, tolerability, and pharmacokinetic profile of single or multiple oral doses of ABSK061 mini-tablets and to evaluate the effect of soft food with ABSK061 mini-tablets on its pharmacokinetic profile in healthy adult participants Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ABSK061
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 17 May 2025to 14 Apr 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of Single or Multiple Oral Doses of ABSK061 Mini-tablets and to Evaluate the Effect of Soft Food With ABSK061 Mini-tablets on Its Pharmacokinetic Profile in Healthy Adult Participants
To main objective is to evaluate the safety, tolerability, and pharmacokinetic profile of single or multiple oral doses of ABSK061 mini-tablets and to evaluate the effect of soft food with ABSK061 mini-tablets on its pharmacokinetic profile in healthy adult participants
- Conditions
- Healthy
- Being tested
- ABSK061
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABSK061Drug
A total of 18 healthy participants were planned to be enrolled in Part I and randomized 1: 1: 1 to Sequences A, B, and C. Participants in three sequences received a single dose of ABSK061 at doses of 1 mg, 10 mg, and 35 mg.
ABSK061Drug
A total of 12 healthy participants were planned to be enrolled in Part II, with multiple dose escalation trials prespecified in Sequences D and E, with 6 healthy participants in each sequence. In this MAD study, participants in Sequence D received ABSK061 microchips 5 mg QD(once a day) for 4 consecutive days.
ABSK061Drug
Part III plans to include 12 healthy participants randomized 1: 1: 1 to Sequence F, Sequence G, or Sequence H to receive a single oral dose of ABSK061 in triplicate doses of Treatment 1, Treatment 2, Treatment 3. Treatment 1 is 5 mg ABSK061 taken with 180 mL of water, Treatment 2 is 5 mg ABSK061 taken with a spoon of yogurt (approximately 15 mL), and Treatment 3 is administered with 5 mg ABSK061 with a spoon of applesauce (approximately 15 mL).
| Study group | Role | What they receive |
|---|---|---|
| Single oral dose of ABSK061 | Experimental | Pharmacokinetic profile (PK) and safety of a single oral dose Receives: Drug: ABSK061 |
| Multiple oral doses of ABSK061 | Experimental | The safety, tolerability, and PK profile of multiple oral doses of ABSK061 Receives: Drug: ABSK061 |
| Food Effect on ABSK061 | Experimental | Food Effect Tablet Formulation Receives: Drug: ABSK061 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics single-dose Cmax
maximum plasma concentration (Cmax)
Measured: Up to 48 hours post-dose
Pharmacokinetics multiple-dose Cmax
maximum steady-state plasma concentration (Cmax)
Measured: Up to 24 hours post-dose
Pharmacokinetics multiple-dose Cmin
average steady-state trough plasma concentration (Cmin)
Measured: Up to 24 hours post-dose
Pharmacokinetics single dose Tmax
time to reach maximum plasma concentration (Tmax)
Measured: Up to 48 hours post-dose
Pharmacokinetics single and multiple dose AUC
area under the plasma concentration-time curve (AUC)
Measured: Up to 48 hours post-dose
Pharmacokinetics multiple-dose RAUC
accumulation ratio for AUC
Measured: Up to 24 hours post-dose
Pharmacokinetics multiple-dose RCmax
accumulation ratio for Cmax (RCmax)
Measured: Up to 24 hours post-dose
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
number of participants with adverse events (AEs), serious adverse events (SAEs), as a measure of safety and tolerability
Measured: Initiation of study treatment up to 18-days post treatment
Number of participants with abnormal laboratory tests results and abnormal physical exam findings
Frequency in changes in laboratory parameters and physical signs of toxicity
Measured: Initiation of study treatment up to 18-days post treatment
Secondary outcomes (3)
Pharmacokinetics single dose CL/F
apparent total clearance (CL/F)
Measured: Up to 48 hours post-dose
Pharmacokinetics single dose Vz/F
apparent volume of distribution (Vz/F)
Measured: Up to 48 hours post-dose
Pharmacokinetics single dose t1/2
half-life of ABSK061
Measured: Up to 48 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start17 May 2025
- Primary completion30 Jul 2025
- Study completion14 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Abbisko Therapeutics Co, LtdThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbisko Therapeutics Co, Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07007546
- Sponsor's protocol ID
- ABSK061-102
- Status last verified
- Jun 2026
- First submitted
- 14 May 2025
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of Single or Multiple Oral Doses of ABSK061 Mini-tablets and to Evaluate the Effect of Soft Food With ABSK061 Mini-tablets on Its Pharmacokinetic Profile in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT07007546
- Acronym / sponsor ID
- ABSK061-102
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Abbisko Therapeutics Co, LtdIndustry (pharma, biotech, devices)
- Study start
- 17 May 2025 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 14 Apr 2026 (actual)
- First posted
- 6 Jun 2025 (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.
To main objective is to evaluate the safety, tolerability, and pharmacokinetic profile of single or multiple oral doses of ABSK061 mini-tablets and to evaluate the effect of soft food with ABSK061 mini-tablets on its pharmacokinetic profile in healthy adult participants
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Single oral dose of ABSK061 | Experimental | Drug: ABSK061Pharmacokinetic profile (PK) and safety of a single oral dose |
| Multiple oral doses of ABSK061 | Experimental | Drug: ABSK061The safety, tolerability, and PK profile of multiple oral doses of ABSK061 |
| Food Effect on ABSK061 | Experimental | Drug: ABSK061Food Effect Tablet Formulation |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| ABSK061A total of 18 healthy participants were planned to be enrolled in Part I and randomized 1: 1: 1 to Sequences A, B, and C. Participants in three sequences received a single dose of ABSK061 at doses of 1 mg, 10 mg, and 35 mg. | Drug | Single oral dose of ABSK061 |
| ABSK061A total of 12 healthy participants were planned to be enrolled in Part II, with multiple dose escalation trials prespecified in Sequences D and E, with 6 healthy participants in each sequence. In this MAD study, participants in Sequence D received ABSK061 microchips 5 mg QD(once a day) for 4 consecutive days. | Drug | Multiple oral doses of ABSK061 |
| ABSK061Part III plans to include 12 healthy participants randomized 1: 1: 1 to Sequence F, Sequence G, or Sequence H to receive a single oral dose of ABSK061 in triplicate doses of Treatment 1, Treatment 2, Treatment 3. Treatment 1 is 5 mg ABSK061 taken with 180 mL of water, Treatment 2 is 5 mg ABSK061 taken with a spoon of yogurt (approximately 15 mL), and Treatment 3 is administered with 5 mg ABSK061 with a spoon of applesauce (approximately 15 mL). | Drug | Food Effect on ABSK061 |
Primary outcome
Pharmacokinetics single-dose Cmax
Time frame: Up to 48 hours post-dose
maximum plasma concentration (Cmax)
Pharmacokinetics multiple-dose Cmax
Time frame: Up to 24 hours post-dose
maximum steady-state plasma concentration (Cmax)
Pharmacokinetics multiple-dose Cmin
Time frame: Up to 24 hours post-dose
average steady-state trough plasma concentration (Cmin)
Pharmacokinetics single dose Tmax
Time frame: Up to 48 hours post-dose
time to reach maximum plasma concentration (Tmax)
Pharmacokinetics single and multiple dose AUC
Time frame: Up to 48 hours post-dose
area under the plasma concentration-time curve (AUC)
Pharmacokinetics multiple-dose RAUC
Time frame: Up to 24 hours post-dose
accumulation ratio for AUC
Pharmacokinetics multiple-dose RCmax
Time frame: Up to 24 hours post-dose
accumulation ratio for Cmax (RCmax)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Initiation of study treatment up to 18-days post treatment
number of participants with adverse events (AEs), serious adverse events (SAEs), as a measure of safety and tolerability
Number of participants with abnormal laboratory tests results and abnormal physical exam findings
Time frame: Initiation of study treatment up to 18-days post treatment
Frequency in changes in laboratory parameters and physical signs of toxicity
3 secondary outcomes
Pharmacokinetics single dose CL/F
Time frame: Up to 48 hours post-dose
Pharmacokinetics single dose Vz/F
Time frame: Up to 48 hours post-dose
Pharmacokinetics single dose t1/2
Time frame: Up to 48 hours post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 ABSK061 in people with Healthy, run by Abbisko Therapeutics Co, Ltd at 1 site in China.
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 4 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: finished, as of the sponsor's last update on 29 Jun 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 China. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics single-dose Cmax (time frame: Up to 48 hours post-dose). The study lists 9 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 29 Jun 2026.