Plaque PsoriasisPhase 1NCT07024602
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of ASC50 Tables in Healthy Participants and Participants With Plaque Psoriasis
A Phase 1 study of Plaque Psoriasis, run by Ascletis Pharma (China) Co., Limited at 1 site in United States.
Trial summary
This is a phase I, randomized, double-blind, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, food effect of ASC50 tablets in healthy adult participants and adult participants with mild to moderate plaque psoriasis. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Plaque Psoriasis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2025to 1 Jul 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female participants between 18 to 65 years of age inclusive, at the time of screening.
- Willing and able to give informed consent prior to any study specific procedures being performed.
- Have venous access sufficient to allow for blood sampling
Who cannot join
- Female participants who are pregnant, breastfeeding or plan to be pregnant during the study period and 3 months after last dose.
- History or presence of any clinically relevant acute or chronic medical or psychiatric condition that could interfere with the subject's safety during the clinical study or expose the subject to undue risk as judged by the Investigator.
- Have received systemic immunosuppressive therapy (MTX, apremilast, azathioprine, cyclosporine, 6-thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, and tacrolimus) within 4 weeks of first administration of study drug.
- Have any other conditions, which, in the opinion of the investigator or sponsor, would make the participant unsuitable for inclusion or could interfere with the participant participating in or completing the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomized, Double-blind, Placebo Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of ASC50 Tablets in Healthy Adult Participants and Adult Participants With Mild to Moderate Plaque Psoriasis
This is a phase I, randomized, double-blind, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, food effect of ASC50 tablets in healthy adult participants and adult participants with mild to moderate plaque psoriasis.
- Conditions
- Plaque Psoriasis
- Being tested
- ASC50 tablets or matching placebo
- Keywords
- ASC50, Plaque Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASC50 tablets or matching placeboDrug
Drug: ASC50 administered orally Drug: Placebo administered orally
| Study group | Role | What they receive |
|---|---|---|
| SAD Cohort 1 | Experimental | Participants will receive a single ASC50 (Dose 1) administration or matching placebo Receives: Drug: ASC50 tablets or matching placebo |
| SAD Cohort 2 | Experimental | Participants will receive a single ASC50 (Dose 2) administration or matching placebo Receives: Drug: ASC50 tablets or matching placebo |
| SAD Cohort 3 | Experimental | Participants will receive a single ASC50 (Dose 3) administration or matching placebo Receives: Drug: ASC50 tablets or matching placebo |
| SAD Cohort 4 | Experimental | Participants will receive a single ASC50 (Dose 4) administration or matching placebo Receives: Drug: ASC50 tablets or matching placebo |
| SAD Cohort 5 | Experimental | Participants will receive a single ASC50 (Dose 5) administration or matching placebo Receives: Drug: ASC50 tablets or matching placebo |
| SAD Cohort 6 | Experimental | Participants will receive a single ASC50 (Dose 6) administration or matching placebo Receives: Drug: ASC50 tablets or matching placebo |
| Repeated Dose Cohort 1 | Experimental | Participants will receive ASC50 (Dose 1) or matching placebo for 28 days, QD Receives: Drug: ASC50 tablets or matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Evaluate the incidence of Serious Adverse Events (SAEs) and Adverse Events (AEs)
Measured: Up to Day 7
Adverse Events
Evaluate the incidence of Serious Adverse Events (SAEs) and Adverse Events (AEs)
Measured: Up to Day 43
Secondary outcomes (14)
AUC
Evaluate the Area under the plasma concentration versus time curve of ASC50
Measured: Up to Day 7
AUC
Evaluate the Area under the plasma concentration versus time curve of ASC50
Measured: Up to Day 34
Cmax
Evaluate the Peak Plasma Concentration of ASC50
Measured: Up to Day 7
Cmax
Evaluate the Peak Plasma Concentration of ASC50
Measured: Up to Day 34
T1/2
Evaluate the Terminal-Phase Half-Life of ASC50
Measured: Up to Day 7
T1/2
Evaluate the Terminal-Phase Half-Life of ASC50
Measured: Up to Day 34
Tmax
Evaluate the time to reach the maximum concentration of ASC50
Measured: Up to Day 7
Tmax
Evaluate the time to reach the maximum concentration of ASC50
Measured: Up to Day 34
IL-17A
Changes in IL-17A after ASC50 administration
Measured: Up to Day 7
IL-17A
Changes in IL-17A after ASC50 administration
Measured: Up to Day 29
Beta Defensin-2
Changes in Beta Defensin-2 after ASC50 administration
Measured: Up to Day 29
IL-19
Changes in IL-19 after ASC50 administration
Measured: Up to Day 29
Psoriasis Area and Severity Index (PASI)
Changes in Psoriasis Area and Severity Index (PASI) after ASC50 treatment.
Measured: Up to Day 43
Target Lesion Severity Score (TLSS)
Changes in Target Lesion Severity Score (TLSS)after ASC50 treatment.
Measured: Up to Day 43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start4 Jun 2025
- Primary completion1 Jul 2026
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- 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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ascletis Pharma (China) Co., Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07024602
- Sponsor's protocol ID
- ASC50-101
- Status last verified
- Sep 2026
- First submitted
- 2 Jun 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-blind, Placebo Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of ASC50 Tablets in Healthy Adult Participants and Adult Participants With Mild to Moderate Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT07024602
- Acronym / sponsor ID
- ASC50-101
- Conditions
- Plaque Psoriasis
- Keywords
- ASC50, Plaque Psoriasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Ascletis Pharma (China) Co., LimitedIndustry (pharma, biotech, devices)
- Study start
- 4 Jun 2025 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 17 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.
This is a phase I, randomized, double-blind, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, food effect of ASC50 tablets in healthy adult participants and adult participants with mild to moderate plaque psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| SAD Cohort 1 | Experimental | Drug: ASC50 tablets or matching placeboParticipants will receive a single ASC50 (Dose 1) administration or matching placebo |
| SAD Cohort 2 | Experimental | Drug: ASC50 tablets or matching placeboParticipants will receive a single ASC50 (Dose 2) administration or matching placebo |
| SAD Cohort 3 | Experimental | Drug: ASC50 tablets or matching placeboParticipants will receive a single ASC50 (Dose 3) administration or matching placebo |
| SAD Cohort 4 | Experimental | Drug: ASC50 tablets or matching placeboParticipants will receive a single ASC50 (Dose 4) administration or matching placebo |
| SAD Cohort 5 | Experimental | Drug: ASC50 tablets or matching placeboParticipants will receive a single ASC50 (Dose 5) administration or matching placebo |
| SAD Cohort 6 | Experimental | Drug: ASC50 tablets or matching placeboParticipants will receive a single ASC50 (Dose 6) administration or matching placebo |
| Repeated Dose Cohort 1 | Experimental | Drug: ASC50 tablets or matching placeboParticipants will receive ASC50 (Dose 1) or matching placebo for 28 days, QD |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female participants between 18 to 65 years of age inclusive, at the time of screening.
- Willing and able to give informed consent prior to any study specific procedures being performed.
- Have venous access sufficient to allow for blood sampling
Key exclusion criteria (4 listed)
- Female participants who are pregnant, breastfeeding or plan to be pregnant during the study period and 3 months after last dose.
- History or presence of any clinically relevant acute or chronic medical or psychiatric condition that could interfere with the subject's safety during the clinical study or expose the subject to undue risk as judged by the Investigator.
- Have received systemic immunosuppressive therapy (MTX, apremilast, azathioprine, cyclosporine, 6-thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, and tacrolimus) within 4 weeks of first administration of study drug.
- Have any other conditions, which, in the opinion of the investigator or sponsor, would make the participant unsuitable for inclusion or could interfere with the participant participating in or completing the 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 |
|---|---|---|
| ASC50 tablets or matching placeboDrug: ASC50 administered orally Drug: Placebo administered orally | Drug | Repeated Dose Cohort 1, SAD Cohort 1, SAD Cohort 2, SAD Cohort 3, SAD Cohort 4, SAD Cohort 5, SAD Cohort 6 |
Primary outcome
Adverse Events
Time frame: Up to Day 7
Evaluate the incidence of Serious Adverse Events (SAEs) and Adverse Events (AEs)
Adverse Events
Time frame: Up to Day 43
Evaluate the incidence of Serious Adverse Events (SAEs) and Adverse Events (AEs)
14 secondary outcomes
AUC
Time frame: Up to Day 7
AUC
Time frame: Up to Day 34
Cmax
Time frame: Up to Day 7
Cmax
Time frame: Up to Day 34
T1/2
Time frame: Up to Day 7
T1/2
Time frame: Up to Day 34
Tmax
Time frame: Up to Day 7
Tmax
Time frame: Up to Day 34
IL-17A
Time frame: Up to Day 7
IL-17A
Time frame: Up to Day 29
Beta Defensin-2
Time frame: Up to Day 29
IL-19
Time frame: Up to Day 29
Psoriasis Area and Severity Index (PASI)
Time frame: Up to Day 43
Target Lesion Severity Score (TLSS)
Time frame: Up to Day 43
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 30 Sep 2026.
- Individual participant dataSharing planned: No
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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 of Plaque Psoriasis, run by Ascletis Pharma (China) Co., Limited at 1 site in United States.
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 3 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 30 Sep 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 United States. 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?
Adverse Events (time frame: Up to Day 7). The study lists 2 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 30 Sep 2026.