A Phase 1 interventional study of HCXT-2001 Tablets and Placebo in Psoriasis, sponsored by Shanghai Peptidstar Therapeutics Limited. Not yet recruiting at 3 sites in New Zealand. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Shanghai Peptidstar Therapeutics Limited · Phase 1, Interventional, and Treatment
The goal of this intervention study is to assess the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of HCXT-2001 Tablets and HCXT-2001 Tablets(A) in Healthy Participants. The main parameters it aims to answer are: Does a single dose of HCXT-2001 Tablets and HCXT-2001 Tablets(A) in healthy participants impact the Safety, Tolerability, Pharmacokinetics, and Immunogenicity profiles? This study will be a randomized, double blind, placebo-controlled study.
2,028 studies on the registry are indexed under Psoriasis; 275 are open to participants now.
This study's planned enrollment of 40 is below the median of 75 across 1,565 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →This is the only study on the registry with Shanghai Peptidstar Therapeutics Limited as lead sponsor.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 13, 2026. See what changed
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.
Exclusion Criteria:
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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
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.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: HCXT-2001 Tablets
Drug: HCXT-2001 Tablets
Drug: Placebo
Drug: HCXT-2001 Tablets(A)
Drug: HCXT-2001 Tablets(A)
Drug: Placebo
Drug: Placebo
Drug: Placebo
Two tablets taken orally in a fasted state
Two tablets taken orally in a fasted state
Two tablets taken orally in a fasted state
One tablet taken orally in a fasted state
One tablet taken orally in a fasted state
One tablet taken orally in a fasted state
Number of participants with AEs,SEAs, with abnormal - vital signs,physcial examinations,clinical laboratory results ,12-lead ECGs and stool routine tests
Time frame: Day 1 to Day 50
Maximum concentration of the drug (Cmax) following a single oral dose of HCXT-2001 tablets and HCXT-2001 tablets(A).
Will be calculated using the non-compartmental analysis.
Time frame: Day 1 to Day 50
Time to maximum concentration (Tmax) following a single oral dose of HCXT-2001 tablets and HCXT-2001 tablets(A).
Will be calculated using the non-compartmental analysis.
Time frame: Day 1 to Day 50
Area under the plasma concentration-time curve (AUC, including AUC0-t and AUC0-inf, etc.) following a single oral dose of HCXT-2001 tablets and HCXT-2001 tablets(A).
Will be calculated using the non-compartmental analysis.
Time frame: Day 1 to Day 50
Apparent volume of distribution (Vd/F) following a single oral dose of HCXT-2001 tablets and HCXT-2001 tablets(A).
Will be calculated using the non-compartmental analysis.
Time frame: Day 1 to Day 50
Apparent clearance (CL/F) following a single oral dose of HCXT-2001 tablets and HCXT-2001 tablets(A)
Will be calculated using the non-compartmental analysis.
Time frame: Day 1 to day 50
Plasma elimination half-life (t1/2) following a single oral dose of HCXT-2001 tablets and HCXT-2001 tablets(A).
Will be calculated using the non-compartmental analysis.
Time frame: Day 1 to Day 50
Mean residence time (MRT) following a single oral dose of HCXT-2001 tablets and HCXT-2001 tablets(A).
Will be calculated using the non-compartmental analysis.
Time frame: Day 1 to Day 50
Anti-drug antibodies (ADAs) following a single oral dose of HCXT-2001 tablets and HCXT-2001 tablets(A).
Time frame: Day 1 to Day 50
Neutralizing antibodies (Nabs) following a single oral dose of HCXT-2001 tablets and HCXT-2001 tablets(A).
Time frame: Day 1 to Day 50
Start is estimated for Oct 2026; primary completion for Nov 2026, 0 months later.
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 planned 0 months is below that.
Counting every sponsor, half of 155 studies reached it within 10 months; a quarter within 5 and three quarters within 17.
Start moved once since we started tracking on Sep 25, 2026: Aug 2026 → Oct 2026, on Oct 13, 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.
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 ↗
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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