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Healthy SubjectPhase 1NCT05497635

A Study of STSA-1002 in Healthy Subjects

A Phase 1 study testing STSA-1002 Injection in people with Healthy Subject, run by Staidson (Beijing) Biopharmaceuticals Co., Ltd at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a Phase Ib, randomized, double-blind, placebo-controlled, multiple dose, dose escalation safety, tolerability,pharmacokinetic and pharmacodynamic study of STSA-1002 injection in healthy subjects. A total of 26 healthy subjects were enrolled in three dosage groups. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Subject
What is being tested?
STSA-1002 Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
26 participants
Where
2 sitesChina
Study dates
14 Oct 2022to 6 Apr 2023
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 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy subjects, aged ≥ 18 but ≤ 45, male and female.
  • Weight:Male≥50.0kg,Female≥45kg;Body mass index: 19.0-26.0 kg/m2, inclusive.
  • Medical history, vital signs, physical examination, laboratory examination (including blood routine, urine routine, blood biochemistry, coagulation function test, etc.) and all tests related to the test were normal or abnormal as determined by the researcher and had no clinical significance.
  • Subjects (including their partners) must take effective contraceptive measures and have no birth plan or sperm or egg donation plan during the trial period and within 6 months after the end of the last administration.
  • Subjects are aware of the content, process and possible adverse reactions of the study and voluntarily signed the informed consent form(ICF).

Who cannot join

  • History of tuberculosis; or combined with mixed lymphocyte culture + interferon assay results, chest imaging comprehensive evaluation of tuberculosis infection (if necessary, tuberculosis experts should be jointly evaluated).
  • Any clinically serious diseases such as respiratory, circulatory, digestive, urinary, blood, endocrine, neurological or mental disorder, or a history of the above diseases or any other diseases or physiological conditions that can interfere with the test results.
  • With any major surgical or surgical that possibly affects drug absorption, distribution, metabolism or excretion(Except appendicitis) within 2 months before screening or plan to undergo surgery during the study period.
  • Subjects with allergies or allergies to any components of the investigational drug and its excipients(such as allergies to two or more drugs, food, pollen), or the IgE is higher than the upper limit of normal.
  • Positive screening test results for human immunodeficiency virus (HIV) antibodies, syphilis-specific antibody, hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCVAb).
  • Subjects with abnormal blood white blood cell count and absolute neutrophil count during the screening period with clinical significance; or hemoglobin: male <120g/L or female <110g/L.
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  • Drug abuse within 1 year before screening [such as morphine, ketamine (K powder), THC (marijuana), methamphetamine (ice), MDMA (ecstasy) ), cocaine, etc.]; or positive urine screening for drug abuse.
  • Subjects who have taken drugs that may affect immune function within 6 months before screening, have received any monoclonal antibody or biological agent for treatment (for any illness) within the previous 3 months, and have taken prescription drugs,non-prescription drugs,chinese herbal medicine within 14 days before screening.
  • Alcoholism within 6 months before screening (drinking more than 14 units of alcohol per week: 1 unit = 285mL of beer, or 25mL of spirits, or 100mL of wine) or unable to stop consuming any alcoholic products after enrollment until the entire study period or a positive alcohol breath test result.
  • Subjects who smoking (more than 5 cigarettes per day on average) within 3 months before screening or who could not stop using any tobacco products until the whole study period after enrollment.
  • Subjects who drink too much (more than 8 cups a day, 1 cup = 200 mL) of tea, coffee and other beverages rich in xanthine within 3 months before screening, or food or beverages that affect drug absorption, distribution, metabolism, and excretion.
  • Donation of blood or lost more than 400ml within 3 months before the first investigational product administration or plan to donate blood or blood components during the study period or within 3 months after the end of the study, or have a history of blood transfusion within 4 weeks before the first drug use of the study.
  • Subjects who participated in any unmarked drug, vaccine or medical device clinical trial within 3 months before screening and applied the drug, vaccine or medical device in the trial.
  • Vaccination within 14 days before the first dose or ready to be vaccinated during the study period to 2 months after the end of the study.
  • Subjects who have used long-acting estrogen or progestogen injections or implants within 6 months before the study or those who have used short-acting contraceptives within 4 weeks before the study.
  • Female subjects who have had unprotected sex within 14 days prior to screening.
  • Blood β-HCG test positive or above the upper limit of the normal range (Female subjects).
  • Pregnant or lactating.
  • Any food or drink rich in xanthine (such as coffee, strong tea, chocolate, etc.) or food or drink that affects drug absorption, distribution, metabolism, and excretion within 48 hours before administration.
  • Unable to follow a unified diet (such as special requirements for diet, intolerance to standard meals, etc.).
  • Intolerance to venipuncturing blood collection, transfusion, or a history of blood and needle sickness.
  • Other circumstances in which the researcher considers it inappropriate to participate in the study.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Beijing Shijitan Hospital, Capital Medical University

    Beijing, Beijing Municipality, 102600

  • The Second Affiliated Hospital Of Xingtai Medical College

    Xingtai, Hebei, 054000

Other trials in China

About this study

Official title: A Randomized,Double-blind, Placebo-controlled, Multiple Ascending-Dose Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of STSA-1002 Injection in Healthy Subjects

This study is a Phase Ib, randomized, double-blind, placebo-controlled, multiple dose, dose escalation safety, tolerability,pharmacokinetic and pharmacodynamic study of STSA-1002 injection in healthy subjects. A total of 26 healthy subjects were enrolled in three dosage groups.

Conditions
Healthy Subject
Being tested
STSA-1002 Injection, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • STSA-1002 InjectionDrug

    Intravenous injection

  • PlaceboDrug

    Intravenous injection

Study groups in NCT05497635
Study groupRoleWhat they receive
A low dose of groupExperimentalAll subjects will be randomized to receive low dose of STSA-1002 or dose-matched placebo.
Receives: Drug: STSA-1002 Injection; Drug: Placebo
A middle dose of groupExperimentalAll subjects will be randomized to receive middle dose of STSA-1002 or dose-matched placebo.
Receives: Drug: STSA-1002 Injection; Drug: Placebo
A high dose of groupExperimentalAll subjects will be randomized to receive high dose of STSA-1002 or dose-matched placebo.
Receives: Drug: STSA-1002 Injection; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Adverse Events、Clinically Significant Laboratory Abnormalities、Clinically Significant Electrocardiogram、Vital Signs And Physical Examination Abnormalities.

    To evaluate the safety and tolerability of multiple intravenous administration of STSA-1002 in healthy adult subjects.

    Measured: Up to Study Day 56

  2. Maximum plasma concentration (Cmax)

    To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1002 in healthy adult subjects

    Measured: From Day 0 to Day 56

  3. Area under the plasma concentration-time curve from time 0 to the collection time point t of the last measurable concentration (AUC0-t)

    To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1002 in healthy adult subjects

    Measured: From Day 0 to Day 56

  4. Area under the plasma concentration-time curve from time 0 to infinity (AUC0-∞)

    To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1002 in healthy adult subjects

    Measured: From Day 0 to Day 56

  5. Time of maximum concentration (Tmax)

    To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1002 in healthy adult subjects

    Measured: From Day 0 to Day 56

  6. Elimination half-life (t1/2)

    To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1002 in healthy adult subjects

    Measured: From Day 0 to Day 56

  7. Mean residence time (MRT)

    To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1002 in healthy adult subjects

    Measured: From Day 0 to Day 56

  8. Clearance (CL)

    To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1002 in healthy adult subjects

    Measured: From Day 0 to Day 56

  9. Apparent volume of distribution (Vz)

    To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1002 in healthy adult subjects

    Measured: From Day 0 to Day 56

  10. Maximum Concentration of the Analyte in Plasma at steady state(Cmax, ss)

    To evaluate the multidose PK characteristics of STSA-1002 in healthy adult subjects

    Measured: From Day 0 to Day 56

  11. Minimum Measured Concentration of the Analyte in Plasma at Steady State(Cmin, ss)

    To evaluate the multidose PK characteristics of STSA-1002 in healthy adult subjects

    Measured: From Day 0 to Day 56

  12. Time-averaged concentration at steady state(Cav, ss)

    To evaluate the multidose PK characteristics of STSA-1002 in healthy adult subjects

    Measured: From Day 0 to Day 56

  13. Area under the concentration curve from time 0 extrapolate to infinite time(AUCinf,ss)

    To evaluate the multidose PK characteristics of STSA-1002 in healthy adult subjects

    Measured: From Day 0 to Day 56

  14. Degree of fluctuation(DF)

    To evaluate the multidose PK characteristics of STSA-1002 in healthy adult subjects

    Measured: From Day 0 to Day 56

  15. Accumulation factor

    To evaluate the multidose PK characteristics of STSA-1002 in healthy adult subjects

    Measured: From Day 0 to Day 56

Secondary outcomes (2)

  1. Change from baseline in concentration of free C5a and anti-drug antibody

    To evaluate the pharmacodynamics (PD) characteristics and immunogenicity of STSA-1002 in healthy subjects

    Measured: From Day 0 to Day 56

  2. Change from baseline in concentration of Myeloperoxidase（MPO）、Neutrophil elastase（NE）、Proteinase3（PR3）、 C-X-C chemokine receptor 1(CXCR1)

    To evaluate the effect of STSA-1002 on MPO、NE、PR3、CXCR1

    Measured: From Day 0 to Day 56

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2022
  2. Study start14 Oct 2022
  3. Primary completion6 Apr 2023
  4. Study completion6 Apr 2023

Resources

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
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05497635
Sponsor's protocol ID
STSA-1002-03
Status last verified
Apr 2023
First submitted
1 Aug 2022
Last updated
18 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Fang Y, Wang X, Qi L, Tong Y, Wei Y, Li Z, Liu C, Liu J, Cheng X, Liu X, Liu F, Li Y, Li Y, Liu L, Sun M, Wang Y, Wang X. Safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of STSA-1002, recombinant anti-human C5a fully human monoclonal antibody, in a randomized, first-in-human phase I study in healthy adults. Front Pharmacol. 2026 Jun 18;17:1838620. doi: 10.3389/fphar.2026.1838620. eCollection 2026.

    PubMed 42394970

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing STSA-1002 Injection in people with Healthy Subject, run by Staidson (Beijing) Biopharmaceuticals Co., Ltd at 2 sites in China.

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 22 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 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. 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?

Incidence of Adverse Events、Clinically Significant Laboratory Abnormalities、Clinically Significant Electrocardiogram、Vital Signs And Physical Examination Abnormalities. (time frame: Up to Study Day 56). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05497635, which also lists 1 linked publication.

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 18 Apr 2023.

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