ClinicalTrials.gg
CompletedNCT07024602Updated Sep 30, 2026

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 interventional study of ASC50 tablets or matching placebo in Plaque Psoriasis, sponsored by Ascletis Pharma (China) Co., Limited. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by Ascletis Pharma (China) Co., Limited (part of Ascletis Pharma Inc.) · Phase 1, Interventional, and Treatment

Updated Sep 30, 2026Now CompletedPrimary completion moved+3 moreGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
55
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 763 studies in Psoriasis with a site in United States — 54 open to participants now, 85 under way, 19 of them phase 3. Psoriasis · United States.

Enrollment
377th of 672
55 · median 77
Started
2025
with 24 others
Phase 1
85 of 763
5 open now
Registered
735th of 763
by date

Among the 763 studies in Psoriasis with a site in United States, this one is the 377th largest by enrollment of the 672 interventional ones that give a count, is one of 25 that started in 2025, is one of 85 in phase 1, and was the 735th registered.

Psoriasis

2,028 studies on the registry are indexed under Psoriasis; 275 are open to participants now.

Browse Psoriasis studies →

Open to participants now

54 of the 763 studies in Psoriasis with a site in United States are open now. Recruiting first, the newest first:

49 more — sign in →

All 54 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 174 Psoriasis studies recruiting now, 91 (52%) set no upper age limit and 67 (39%) stop at 75 or younger; 25 take children under 18; 40 take healthy volunteers.

This study: 18 Years to 65 Years · all sexes · healthy volunteers too.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 763 studies in Psoriasis with a site in United States, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Plaque Psoriasis

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Keywords

  • ASC50
  • Plaque Psoriasis
04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Male and female participants between 18 to 65 years of age inclusive, at the time of screening.
  2. Willing and able to give prior to any study specific procedures being performed.
  3. Have venous access sufficient to allow for blood sampling

Exclusion criteria

Exclusion Criteria:

  1. Female participants who are pregnant, breastfeeding or plan to be pregnant during the study period and 3 months after last dose.
  2. History or presence of any 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.
  3. Have received systemic therapy (MTX, apremilast, azathioprine, cyclosporine, 6-thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, and tacrolimus) within 4 weeks of first administration of study drug.
  4. 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
55 participants (actual)

Study arms

  • Experimental
    SAD Cohort 1

    Participants will receive a single ASC50 (Dose 1) administration or matching placebo

    Drug: ASC50 tablets or matching placebo

  • Experimental
    SAD Cohort 2

    Participants will receive a single ASC50 (Dose 2) administration or matching placebo

    Drug: ASC50 tablets or matching placebo

  • Experimental
    SAD Cohort 3

    Participants will receive a single ASC50 (Dose 3) administration or matching placebo

    Drug: ASC50 tablets or matching placebo

  • Experimental
    SAD Cohort 4

    Participants will receive a single ASC50 (Dose 4) administration or matching placebo

    Drug: ASC50 tablets or matching placebo

  • Experimental
    SAD Cohort 5

    Participants will receive a single ASC50 (Dose 5) administration or matching placebo

    Drug: ASC50 tablets or matching placebo

  • Experimental
    SAD Cohort 6

    Participants will receive a single ASC50 (Dose 6) administration or matching placebo

    Drug: ASC50 tablets or matching placebo

  • Experimental
    Repeated Dose Cohort 1

    Participants will receive ASC50 (Dose 1) or matching placebo for 28 days, QD

    Drug: ASC50 tablets or matching placebo

Interventions

  • DrugASC50 tablets or matching placebo

    Drug: ASC50 administered orally Drug: Placebo administered orally

06

What researchers measure

Primary outcomes

  1. Adverse Events

    Evaluate the incidence of Serious Adverse Events (SAEs) and Adverse Events (AEs)

    Time frame: Up to Day 7

  2. Adverse Events

    Evaluate the incidence of Serious Adverse Events (SAEs) and Adverse Events (AEs)

    Time frame: Up to Day 43

Secondary outcomes

  1. AUC

    Evaluate the Area under the plasma concentration versus time curve of ASC50

    Time frame: Up to Day 7

  2. AUC

    Evaluate the Area under the plasma concentration versus time curve of ASC50

    Time frame: Up to Day 34

  3. Cmax

    Evaluate the Peak Plasma Concentration of ASC50

    Time frame: Up to Day 7

  4. Cmax

    Evaluate the Peak Plasma Concentration of ASC50

    Time frame: Up to Day 34

  5. T1/2

    Evaluate the Terminal-Phase Half-Life of ASC50

    Time frame: Up to Day 7

  6. T1/2

    Evaluate the Terminal-Phase Half-Life of ASC50

    Time frame: Up to Day 34

  7. Tmax

    Evaluate the time to reach the maximum concentration of ASC50

    Time frame: Up to Day 7

  8. Tmax

    Evaluate the time to reach the maximum concentration of ASC50

    Time frame: Up to Day 34

  9. IL-17A

    Changes in IL-17A after ASC50 administration

    Time frame: Up to Day 7

  10. IL-17A

    Changes in IL-17A after ASC50 administration

    Time frame: Up to Day 29

  11. Beta Defensin-2

    Changes in Beta Defensin-2 after ASC50 administration

    Time frame: Up to Day 29

  12. IL-19

    Changes in IL-19 after ASC50 administration

    Time frame: Up to Day 29

  13. Psoriasis Area and Severity Index (PASI)

    Changes in Psoriasis Area and Severity Index (PASI) after ASC50 treatment.

    Time frame: Up to Day 43

  14. Target Lesion Severity Score (TLSS)

    Changes in Target Lesion Severity Score (TLSS)after ASC50 treatment.

    Time frame: Up to Day 43

07

Study locations

1 site
  • Ascletis Clinical Site
    Miami, Florida 33144, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2025 to primary completion in Jul 2026, 12 months.

Of 137 industry-sponsored phase 1 interventional studies under Psoriasis, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 16. This study's 12 months is above that.

Counting every sponsor, half of 155 studies reached it within 10 months; a quarter within 5 and three quarters within 17.

Since we started tracking on Sep 25, 2026, the dates moved once, on Sep 30, 2026: primary completion Jun 2026 → Jul 2026 and completion Jun 2026 → Jul 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Jun 2, 2025
First posted
Jun 17, 2025
StartActual
Jun 4, 2025
Primary completionActual
Jul 1, 2026was Jun 2026
CompletionActual
Jul 1, 2026was Jun 2026
Last update
Sep 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Completed
changed Sep 30, 2026
Primary completion
Jun 2026→Jul 1, 2026 (actual)
Sep 30, 2026
Study completion
Jun 2026→Jul 1, 2026 (actual)
Sep 30, 2026
Enrollment
94 (estimated)→55 (actual)
Sep 30, 2026
Interventions
Arm changed MAD Cohort 1→Repeated Dose Cohort 1. Arms removed: MAD Cohort 2·MAD Cohort 3
Sep 30, 2026
Show all 1 update
  1. Sep 30, 2026
    Recruiting→Completed
    Primary completion Jun 2026→Jul 1, 2026 (now actual)
    Study completion Jun 2026→Jul 1, 2026 (now actual)
    Enrollment 94 (estimated)→55 (actual)
    Interventions Arm changed MAD Cohort 1→Repeated Dose Cohort 1. Arms removed: MAD Cohort 2·MAD Cohort 3
    + 5 other changes: index terms, verification date, oversight details, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07024602
Responsible party
Sponsor
First posted
Jun 17, 2025
Start date
Jun 4, 2025
Primary completion
Jul 1, 2026
Completion
Jul 1, 2026
Last update
Sep 30, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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