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HealthyPhase 1NCT05032144

The Safety and Tolerability of STSA-1002 Following Intravenous Infusion in Healthy Subjects

A Phase 1 study testing STSA-1002 injection in people with Healthy, run by Staidson (Beijing) Biopharmaceuticals Co., Ltd at 1 site in United States.

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

A randomized,double-blind,placebo-controlled,single-ascending dose phase Ⅰa study to evaluate the safety,tolerability,pharmacokinetics and pharmacodynamics of STSA-1002 following intravenous infusion in healthy subjects Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
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
40 participants
Where
1 siteUnited States
Study dates
28 Sep 2021to 31 Mar 2022
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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy subjects,aged ≥18 but ≤65，male and female.
  • Body mass index:18.0～32.0kg/m²，inclusive.
  • Subjects(including their partners) agree to take highly effective contraceptive measures during the study,and they have no birth plan or sperm donation plan within 3months after the end of the study.
  • Female and/or male subjects those meet the below criteria:
  • If a female subject of child bearing potential-agrees to use one of the accepted contraceptive regimens from at least 30 days prior to the administration of IMP,during the study,and for at least 3 months after the end of the study. An acceptable method of contraception includes one of the following:
  • Abstinence from heterosexual intercourse Hormonal contraceptives(brith control pills,injectable/implant/insertable hormonal birth control products, transdermal patch) Intrauterine device(with or without hormones) OR agrees to use a double barrier method (e.g. condom and spermicide) . If a female subject of non-childbearing potential - should be surgically sterile (i.e. has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation/occlusion) or in a menopausal state (at least 1 year without menses), as confirmed by Follicle-stimulating hormone (FSH) levels (≥ 40 mIU/mL).
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  • A male subject that engages in sexual activity that has the risk of pregnancy must agree to use a double barrier method (e.g. condom and spermicide) and agree to not donate sperm during the study and for at least 3 months after the end of the study.
  • Medical histories, physical examinations, laboratory examinations and study-related examinations and tests of the subjects show normal results or mild abnormalities with no clinical significance before enrollment, and the Investigator judges that they are eligible.
  • Subjects are aware of the risks of the study, and voluntarily participate in the clinical study and sign an informed consent form (ICF).

Who cannot join

  • History of cardiovascular, respiratory, kidney, liver, metabolism, endocrine, gastrointestinal, blood, nerve, skin and mental illness, cancer or other major disease that in the judgment of the Investigator might put the subject as risk on this study.
  • History of tuberculosis or a recent history of infection within the past 4 weeks.
  • History of recurrent infections.
  • Presence of clinically significant laboratory values during the screening period, as defined by an Investigator.
  • Presence of clinically significant vital signs values or of electrocardiogram (ECG) abnormalities during the screening period, as defined by an Investigator.
  • Subjects who have autoimmune disease or immunodeficiency, or have a family history of related diseases.
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  • Subjects who have allergies, or have or are currently suffering from clinically significant atopic allergies, hypersensitivity or allergic reactions, including known or suspected clinically relevant hypersensitivity or allergic reactions to certain components of the IMP preparation, or a history of allergies to other drugs or biological agents.
  • Positive screening test results for human immunodeficiency virus (HIV-1/HIV-2) antibodies, hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCVAb).
  • Subjects who have received treatment with an investigational drug within 30 days or 5 times the half-life (whichever is longer) prior to screening or 90 days for biologic compounds prior to screening.
  • Subjects who have participated in any vaccine clinical study as subjects within 3 months before enrollment or plan to receive live vaccines during the study period, and subjects who have received vaccines 28 days prior to the IMP administration or plan to receive vaccines within 2 months after the end of the study.
  • 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 previous treatment with any prescribed medications (including vaccines) or over-the-counter (OTC) medications (including herbal medicines such as St John's Wort, homeopathic preparations, vitamins, and minerals) within 7 days prior to IMP administration.
  • Subjects whose daily consumption of coffee, tea and/or cola is more than 750 mL or 25 fl. oz in the last 30 days before enrollment.
  • Subjects who have a positive urine alcohol test or urine drug test before enrollment.
  • Subjects who have nicotine consumption (e.g., smoking, nicotine patch, nicotine chewing gum, or electronic cigarettes) within 3 months prior to screening and inability to refrain from nicotine consumption from screening until end of study.
  • Female subjects who are pregnant or breastfeeding during the screening period and on admission.
  • Subjects whose daily consumption of alcohol at the time of screening or at any time within the prior 6 months is more than 2 standard drinks, where 1 standard drink = 355 mL or 12 oz (1 can) of regular-strength (5%) beer; 150 mL or 5 oz wine; 45 mL or 1.5 oz liquor/spirits (40%).
  • History of substance use disorder (within 1 year of screening).
  • Subjects who have undergone major surgery within 2 months of screening, or who will have elective surgery that will occur during the study period.
  • Subjects who have donated either more than approximately 500 mL of blood (exclusive plasma donation) within 56 days (8 weeks) prior to screening or any plasma within 7 days (1 week) prior to screening.
  • Subjects fails or is unwilling to abstain from strenuous physical activities for at least 48 hours prior to IP administration and throughout the study.
  • Subjects with any factors that would, in the Investigator's judgment, preclude them from participating in this study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • AltaSciences Clinical Kansas, Inc

    Overland Park, Kansas, 66212

Other trials in United States

About this study

Official title: A Randomized,Double-blind,Placebo-controlled,Single-ascending Dose Phase Ⅰa Study to Evaluate the Safety,Tolerability,Pharmacokinetics and Pharmacodynamics of STSA-1002 Following Intravenous Infusion in Healthy Subjects

A randomized,double-blind,placebo-controlled,single-ascending dose phase Ⅰa study to evaluate the safety,tolerability,pharmacokinetics and pharmacodynamics of STSA-1002 following intravenous infusion in healthy subjects

Conditions
Healthy
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

  • STSA-1002 injectionDrug

    Intravenous injection

  • PlaceboDrug

    Intravenous injection

  • STSA-1002 injectionDrug

    Intravenous injection

  • PlaceboDrug

    Intravenous injection

  • STSA-1002 injectionDrug

    Intravenous injection

  • PlaceboDrug

    Intravenous injection

  • STSA-1002 injectionDrug

    Intravenous injection

  • PlaceboDrug

    Intravenous injection

Study groups in NCT05032144
Study groupRoleWhat they receive
Cohort 1:2mg/kgExperimentalAll participants (fasted) received either 2mg/kg of STSA-1002 as a single dose or dose-matched placebo.
Receives: Drug: STSA-1002 injection; Drug: Placebo
Cohort 2:5mg/kgExperimentalAll participants (fasted) received either 5mg/kg of STSA-1002 as a single dose or dose-matched placebo.
Receives: Drug: STSA-1002 injection; Drug: Placebo
Cohort 3:10mg/kgExperimentalAll participants (fasted) received either 10mg/kg of STSA-1002 as a single dose or dose-matched placebo.
Receives: Drug: STSA-1002 injection; Drug: Placebo
Cohort 4:20mg/kgExperimentalAll participants (fasted) received either 20mg/kg of STSA-1002 as a single dose or dose-matched placebo.
Receives: Drug: STSA-1002 injection; Drug: Placebo
Cohort 5:30mg/kgExperimentalAll participants (fasted) received either 30mg/kg of STSA-1002 as a single dose 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 Abnormalities, Clinically Significant Vital Signs Abnormalities And Clinically Significant Physical Examination Abnormalities

    Measured: Day 1 through Day 51

  2. Maximum plasma concentration(Cmax)

    Measured: Up to 1200 hours postdose

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

    Measured: Up to 1200 hours postdose

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

    Measured: Up to 1200 hours postdose

  5. Time of maximum concentration(Tmax)

    Measured: Up to 1200 hours postdose

  6. Elimination half-life(t1/2)

    Measured: Up to 1200 hours postdose

  7. Elimination rate constant of plasma drug concentration in terminal phase(λz)

    Measured: Up to 1200 hours postdose

  8. Last measurable concentration(Clast)

    Measured: Up to 1200 hours postdose

  9. Mean residence time(MRT)

    Measured: Up to 1200 hours postdose

  10. Clearance(CL)

    Measured: Up to 1200 hours postdose

  11. Apparent volume of distribution(Vz)

    Measured: Up to 1200 hours postdose

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: Up to 1200 hours postdose

  2. Change from baseline in concentration of CH50,IL-6,IL-8,TNF-α,IFN-γ

    To evaluate the effect of STSA-1002 on CH50, IL-6, IL-8, TNF-α, IFN-γ

    Measured: Up to 1200 hours postdose

Timeline

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

  1. First posted2 Sep 2021
  2. Study start28 Sep 2021
  3. Primary completion31 Mar 2022
  4. Study completion31 Mar 2022

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
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05032144
Sponsor's protocol ID
STSA-1002-01
Status last verified
Sep 2021
First submitted
19 Aug 2021
Last updated
11 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing STSA-1002 injection in people with Healthy, run by Staidson (Beijing) Biopharmaceuticals Co., Ltd at 1 site in United States.

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 9 inclusion and 21 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 11 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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 Abnormalities, Clinically Significant Vital Signs Abnormalities And Clinically Significant Physical Examination Abnormalities (time frame: Day 1 through Day 51). The study lists 11 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 NCT05032144.

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 11 Apr 2022.

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