Systemic Lupus ErythematosusPhase 1NCT07408908
Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic (PK/PD) Profile of ACT100 in Healthy Participants..
A Phase 1 study testing ACT100 Injection in people with Systemic Lupus Erythematosus and Cutaneous Lupus Erythematosus, run by Xiamen Amoytop Biotech Co., Ltd..
Trial summary
This study is a Phase Ia, single-center, randomized, double-blind, dose-escalation, placebo-controlled clinical trial designed to evaluate the safety, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) profile of ACT100 in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Systemic Lupus Erythematosus, Cutaneous Lupus Erythematosus
- What is being tested?
- ACT100 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 6 Mar 2026to 30 Oct 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must voluntarily participate and sign the informed consent form after being informed of the entire trial process and the potential adverse reactions of the investigational product.
- Healthy male and female participants aged between 18 and 55 years (inclusive) at the time of signing the informed consent form.
- Body mass index (BMI) at screening: 18.5 kg/m^2 ≤ BMI < 28 kg/m^2; body weight ≥ 50 kg (for males) / ≥ 45 kg (for females).
- At screening, physical examination, vital signs, laboratory tests, electrocardiogram (ECG), etc., are all normal or show abnormalities judged by the investigator as having no clinical significance.
- Females of childbearing potential and males must agree to use highly effective contraceptive methods (e.g., intrauterine device, condom) from screening until 3 months after administration of the investigational product and have no plan for sperm or egg donation.
Who cannot join
- History of treatment with any drug targeting the same molecule (BDCA2) as the investigational product.
- A 12-lead electrocardiogram (ECG) at screening showing abnormalities considered clinically significant by the investigator (e.g., QTcF > 450 ms for males or > 470 ms for females).
- History of severe diseases of major organ systems, including but not limited to neurological, cardiovascular, hematological, autoimmune, renal, hepatic, gastrointestinal, pulmonary, endocrine, metabolic, or psychiatric disorders.
- Presence of severe bacterial or viral infection (e.g., pneumonia, sepsis, herpes zoster), or fungal/parasitic infection within 2 months prior to screening; or any symptoms of active or suspected infection within 1 week prior to dosing.
- Chronic infectious diseases such as chronic hepatitis B or C, AIDS, tuberculosis, etc. Exclusion applies if any of the following tests are positive at screening: Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAb), Hepatitis C antibody (HCVAb), Treponema pallidum antibody, Human Immunodeficiency Virus antibody (HIVAb); or if there is evidence of active or latent Mycobacterium tuberculosis infection at screening.
- History of primary immunodeficiency, splenectomy, or any other underlying condition deemed by the investigator to confer a high risk of severe infection.
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- History of severe food or drug allergy, or known allergy to monoclonal antibodies.
- Vaccination with a live attenuated vaccine within 1 month prior to screening, or any other vaccination within half a month prior to screening, or plans to receive any vaccine during the study period.
- Use of any prescription drugs, over-the-counter medications (including Chinese herbal medicines, health supplements, etc.) within 14 days prior to the first dose of the investigational product, unless deemed by both the investigator and sponsor to have no impact on the study.
- History of drug abuse, illicit drug use, or alcohol abuse (history of drug abuse or illicit drug use within the past 5 years; or habitual alcohol intake exceeding 14 units per week within 3 months prior to screening: 1 unit ≈ 285 mL beer, or 25 mL spirits, or 100 mL wine). Participants with a positive alcohol breath test or positive urine drug abuse screening at screening will be excluded.
- Heavy smoking (averaging >5 cigarettes per day) within 3 months prior to screening, or unwillingness to refrain from smoking during the study period.
- Donation or loss of >400 mL of blood within 3 months prior to screening, or >200 mL within 1 month prior to screening; or receipt of blood transfusion or blood products within 3 months prior to screening.
- Participation in another clinical trial involving an investigational drug/therapy within 1 month prior to screening, or within 5 half-lives (based on the known half-life of the prior investigational product, the Investigator's Brochure, or the informed consent form, whichever specifies the longer period).
- History of blood/needle phobia or intolerance to venipuncture, or abnormalities at the potential injection site deemed by the investigator to be unsuitable for subcutaneous administration.
- Females who are pregnant or lactating.
- Any other condition that, in the judgment of the investigator, makes the participant unsuitable for participation in this study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Single-Center, Randomized, Double-Blind, Dose-Escalation, Placebo-Controlled, Phase Ia Study to Evaluate the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic (PK/PD) Profile of ACT100 in Healthy Participants.
This study is a Phase Ia, single-center, randomized, double-blind, dose-escalation, placebo-controlled clinical trial designed to evaluate the safety, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) profile of ACT100 in healthy participants. A total of 6 dose cohorts are planned, with each cohort enrolling 8 participants (including both male and female participants, where 6 will receive the investigational drug and 2 will receive placebo). The total planned enrollment is 48 healthy participants.
- Being tested
- ACT100 Injection, Placebo for ACT100
- Keywords
- Systemic Lupus Erythematosus, Cutaneous Lupus Erythematosus, ACT100, Pharmacokinetics and Pharmacodynamics
- Medical subject headings
- Lupus Erythematosus, Systemic, Lupus Erythematosus, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT100 InjectionDrug
a single 5-mg subcutaneous injection
Placebo for ACT100Drug
a single 5-mg subcutaneous injection
ACT100 InjectionDrug
a single 25-mg subcutaneous injection
Placebo for ACT100Drug
a single 25-mg subcutaneous injection
ACT100 InjectionDrug
a single 100-mg subcutaneous injection
Placebo for ACT100Drug
a single 100-mg subcutaneous injection
ACT100 InjectionDrug
a single 300-mg subcutaneous injection
Placebo for ACT100Drug
a single 300-mg subcutaneous injection
ACT100 InjectionDrug
a single 600-mg subcutaneous injection
Placebo for ACT100Drug
a single 600-mg subcutaneous injection
ACT100 InjectionDrug
a single 800-mg subcutaneous injection
Placebo for ACT100Drug
a single 800-mg subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| ACT100 Cohort 1 | Experimental | Not described Receives: Drug: ACT100 Injection |
| Placebo Group for Cohort 1 | Placebo comparator | Not described Receives: Drug: Placebo for ACT100 |
| ACT100 Cohort 2 | Experimental | Not described Receives: Drug: ACT100 Injection |
| Placebo Group for Cohort 2 | Placebo comparator | Not described Receives: Drug: Placebo for ACT100 |
| ACT100 Cohort 3 | Experimental | Not described Receives: Drug: ACT100 Injection |
| Placebo Group for Cohort 3 | Placebo comparator | Not described Receives: Drug: Placebo for ACT100 |
| ACT100 Cohort 4 | Experimental | Not described Receives: Drug: ACT100 Injection |
| Placebo Group for Cohort 4 | Placebo comparator | Not described Receives: Drug: Placebo for ACT100 |
| ACT100 Cohort 5 | Experimental | Not described Receives: Drug: ACT100 Injection |
| Placebo Group for Cohort 5 | Placebo comparator | Not described Receives: Drug: Placebo for ACT100 |
| ACT100 Cohort 6 | Experimental | Not described Receives: Drug: ACT100 Injection |
| Placebo Group for Cohort 6 | Placebo comparator | Not described Receives: Drug: Placebo for ACT100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event(AE)
Measured: Day 1-84
Serious Adverse Event
Measured: Day 1-84
blood pressure
Measured: Day 1-84
pulse
Measured: Day 1-84
respiration
Measured: Day 1-84
body temperature
Measured: Day 1-84
Number of Participants with Abnormal Physical examination parameters
Measured: Day 1-84
Number of Participants with Abnormal Laboratory Parameters Findings
Measured: Day 1-84
Number of Participants with 12-Lead Electrocardiogram Findings
Measured: Day 1-84
Secondary outcomes (11)
Area Under the plasma concentration-time Curve from time zero to the last measurable concentration(AUC₀-t)
Measured: Day 1-4,7,14,21,28,42,56,70,84
Area Under the plasma concentration-time Curve from time zero extrapolated to infinity(AUC₀-∞)
Measured: Day 1-4,7,14,21,28,42,56,70,84
Maximum observed plasma concentration(Cmax)
Measured: Day 1-4,7,14,21,28,42,56,70,84
Time to reach the maximum observed plasma concentration(Tmax)
Measured: Day 1-4,7,14,21,28,42,56,70,84
Terminal elimination half-life(t1/2)
Measured: Day 1-4,7,14,21,28,42,56,70,84
Apparent clearance (CL/F)
Measured: Day 1-4,7,14,21,28,42,56,70,84
Apparent volume of distribution(Vd/F)
Measured: Day 1-4,7,14,21,28,42,56,70,84
Levels of BDCA2 on the surface of plasmacytoid dendritic cells (pDCs)
Measured: Day 1-3,7,14,28,42,56,70,84
Peripheral blood pDC levels
Measured: Day 1-3,7,14,28,42,56,70,84
Anti-drug antibodies (ADA).
Measured: Day 1,28,56,84
Neutralizing antibodies (NAb)
Measured: Day 1,28,56,84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start6 Mar 2026 (estimated)
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Xiamen Amoytop Biotech Co., Ltd.The 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiamen Amoytop Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Peking Union Medical College Hospital
- Responsible party
- Sponsor
- Investigators
- Xiaohong Han, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07408908
- Sponsor's protocol ID
- ACT100-4-1-001
- Status last verified
- Feb 2026
- First submitted
- 6 Feb 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Randomized, Double-Blind, Dose-Escalation, Placebo-Controlled, Phase Ia Study to Evaluate the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic (PK/PD) Profile of ACT100 in Healthy Participants.
- ClinicalTrials.gov ID
- NCT07408908
- Acronym / sponsor ID
- ACT100-4-1-001
- Keywords
- Systemic Lupus Erythematosus, Cutaneous Lupus Erythematosus, ACT100, Pharmacokinetics and Pharmacodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Xiamen Amoytop Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Peking Union Medical College Hospital
- Study start
- 6 Mar 2026 (estimated)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 13 Feb 2026 (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 study is a Phase Ia, single-center, randomized, double-blind, dose-escalation, placebo-controlled clinical trial designed to evaluate the safety, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) profile of ACT100 in healthy participants. A total of 6 dose cohorts are planned, with each cohort enrolling 8 participants (including both male and female participants, where 6 will receive the investigational drug and 2 will receive placebo). The total planned enrollment is 48 healthy participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| ACT100 Cohort 1 | Experimental | Drug: ACT100 Injection |
| Placebo Group for Cohort 1 | Placebo comparator | Drug: Placebo for ACT100 |
| ACT100 Cohort 2 | Experimental | Drug: ACT100 Injection |
| Placebo Group for Cohort 2 | Placebo comparator | Drug: Placebo for ACT100 |
| ACT100 Cohort 3 | Experimental | Drug: ACT100 Injection |
| Placebo Group for Cohort 3 | Placebo comparator | Drug: Placebo for ACT100 |
| ACT100 Cohort 4 | Experimental | Drug: ACT100 Injection |
| Placebo Group for Cohort 4 | Placebo comparator | Drug: Placebo for ACT100 |
| ACT100 Cohort 5 | Experimental | Drug: ACT100 Injection |
| Placebo Group for Cohort 5 | Placebo comparator | Drug: Placebo for ACT100 |
| ACT100 Cohort 6 | Experimental | Drug: ACT100 Injection |
| Placebo Group for Cohort 6 | Placebo comparator | Drug: Placebo for ACT100 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Participants must voluntarily participate and sign the informed consent form after being informed of the entire trial process and the potential adverse reactions of the investigational product.
- Healthy male and female participants aged between 18 and 55 years (inclusive) at the time of signing the informed consent form.
- Body mass index (BMI) at screening: 18.5 kg/m^2 ≤ BMI < 28 kg/m^2; body weight ≥ 50 kg (for males) / ≥ 45 kg (for females).
- At screening, physical examination, vital signs, laboratory tests, electrocardiogram (ECG), etc., are all normal or show abnormalities judged by the investigator as having no clinical significance.
- Females of childbearing potential and males must agree to use highly effective contraceptive methods (e.g., intrauterine device, condom) from screening until 3 months after administration of the investigational product and have no plan for sperm or egg donation.
Key exclusion criteria (16 listed)
- History of treatment with any drug targeting the same molecule (BDCA2) as the investigational product.
- A 12-lead electrocardiogram (ECG) at screening showing abnormalities considered clinically significant by the investigator (e.g., QTcF > 450 ms for males or > 470 ms for females).
- History of severe diseases of major organ systems, including but not limited to neurological, cardiovascular, hematological, autoimmune, renal, hepatic, gastrointestinal, pulmonary, endocrine, metabolic, or psychiatric disorders.
- Presence of severe bacterial or viral infection (e.g., pneumonia, sepsis, herpes zoster), or fungal/parasitic infection within 2 months prior to screening; or any symptoms of active or suspected infection within 1 week prior to dosing.
- Chronic infectious diseases such as chronic hepatitis B or C, AIDS, tuberculosis, etc. Exclusion applies if any of the following tests are positive at screening: Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAb), Hepatitis C antibody (HCVAb), Treponema pallidum antibody, Human Immunodeficiency Virus antibody (HIVAb); or if there is evidence of active or latent Mycobacterium tuberculosis infection at screening.
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 |
|---|---|---|
| ACT100 Injectiona single 5-mg subcutaneous injection | Drug | ACT100 Cohort 1 |
| Placebo for ACT100a single 5-mg subcutaneous injection | Drug | Placebo Group for Cohort 1 |
| ACT100 Injectiona single 25-mg subcutaneous injection | Drug | ACT100 Cohort 2 |
| Placebo for ACT100a single 25-mg subcutaneous injection | Drug | Placebo Group for Cohort 2 |
| ACT100 Injectiona single 100-mg subcutaneous injection | Drug | ACT100 Cohort 3 |
| Placebo for ACT100a single 100-mg subcutaneous injection | Drug | Placebo Group for Cohort 3 |
| ACT100 Injectiona single 300-mg subcutaneous injection | Drug | ACT100 Cohort 4 |
| Placebo for ACT100a single 300-mg subcutaneous injection | Drug | Placebo Group for Cohort 4 |
| ACT100 Injectiona single 600-mg subcutaneous injection | Drug | ACT100 Cohort 5 |
| Placebo for ACT100a single 600-mg subcutaneous injection | Drug | Placebo Group for Cohort 5 |
| ACT100 Injectiona single 800-mg subcutaneous injection | Drug | ACT100 Cohort 6 |
| Placebo for ACT100a single 800-mg subcutaneous injection | Drug | Placebo Group for Cohort 6 |
Primary outcome
Adverse Event(AE)
Time frame: Day 1-84
Serious Adverse Event
Time frame: Day 1-84
blood pressure
Time frame: Day 1-84
pulse
Time frame: Day 1-84
respiration
Time frame: Day 1-84
body temperature
Time frame: Day 1-84
Number of Participants with Abnormal Physical examination parameters
Time frame: Day 1-84
Number of Participants with Abnormal Laboratory Parameters Findings
Time frame: Day 1-84
Number of Participants with 12-Lead Electrocardiogram Findings
Time frame: Day 1-84
11 secondary outcomes
Area Under the plasma concentration-time Curve from time zero to the last measurable concentration(AUC₀-t)
Time frame: Day 1-4,7,14,21,28,42,56,70,84
Area Under the plasma concentration-time Curve from time zero extrapolated to infinity(AUC₀-∞)
Time frame: Day 1-4,7,14,21,28,42,56,70,84
Maximum observed plasma concentration(Cmax)
Time frame: Day 1-4,7,14,21,28,42,56,70,84
Time to reach the maximum observed plasma concentration(Tmax)
Time frame: Day 1-4,7,14,21,28,42,56,70,84
Terminal elimination half-life(t1/2)
Time frame: Day 1-4,7,14,21,28,42,56,70,84
Apparent clearance (CL/F)
Time frame: Day 1-4,7,14,21,28,42,56,70,84
Apparent volume of distribution(Vd/F)
Time frame: Day 1-4,7,14,21,28,42,56,70,84
Levels of BDCA2 on the surface of plasmacytoid dendritic cells (pDCs)
Time frame: Day 1-3,7,14,28,42,56,70,84
Peripheral blood pDC levels
Time frame: Day 1-3,7,14,28,42,56,70,84
Anti-drug antibodies (ADA).
Time frame: Day 1,28,56,84
Neutralizing antibodies (NAb)
Time frame: Day 1,28,56,84
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
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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.
Xiaohong Han principal investigator
Peking Union Medical College Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ACT100 Injection in people with Systemic Lupus Erythematosus and Cutaneous Lupus Erythematosus, run by Xiamen Amoytop Biotech Co., Ltd..
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 5 inclusion and 16 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: opening soon, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaohong Han (050-69154796, hanxiaohong@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Event(AE) (time frame: Day 1-84). 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 13 Feb 2026.