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NCT07408908Not yet recruitingPhase 1

Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic (PK/PD) Profile of ACT100 in Healthy Participants..

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.

Source: ClinicalTrials.gov · Last updated 13 Feb 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
48 (estimated)
First submitted
6 Feb 2026
Start date
6 Mar 2026
Primary completion date
30 Mar 2027
Lead sponsor
Xiamen Amoytop Biotech Co., Ltd.
Diseases
Lupus (SLE)
NCT number
NCT07408908

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 48
  • From 6 Mar 2026 to the primary completion date, 30 Mar 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • History of treatment with any drug targeting the same molecule (BDCA2) as the investigational product.
  • 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.
  • 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).

Other illness

  • 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.
  • 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.
  • History of severe food or drug allergy, or known allergy to monoclonal antibodies.
  • 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.
  • Any other condition that, in the judgment of the investigator, makes the participant unsuitable for participation in this study.

Other

  • 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).
  • Females who are pregnant or lactating.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 55 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.