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HealthyPhase 1NCT05085197

The Safety and Tolerability of STSA-1005 Following Intravenous Infusion in Healthy Subjects

A Phase 1 study testing STSA-1005 injection in people with Healthy, run by Staidson Biopharma Inc. 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

This was a single ascending dose, randomized, double-blind study assessing the safety, tolerability and pharmacokinetics of STSA-1005 in healthy participants. Four kinds different doses and dose-matched placebo were administered under fasted conditions. 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-1005 injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
32 participants
Where
1 siteUnited States
Study dates
27 Oct 2021to 5 Apr 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

  • Subjects are able to understand and are willing to sign the informed consent form (ICF).
  • Subjects (male or female) must be ≥18 to ≤65years of age inclusive.
  • Healthy subjects according to the results of medical history, physical examination, vital signs, ECG, and clinical laboratory examination. The Investigator considers that the subjects are in good health with no clinically significant heart, liver, kidney, digestive tract, nervous system, respiratory system, mental disorders, and metabolic disorders.
  • Subjects with a body mass index (BMI) of 20-32kg/m^2, inclusive.
  • (1)If a subject is a female of childbearing potential - she should agree to use one of the accepted contraceptive regimens from at least 30 days before screening, during the study, and for at least 3 months after administration of the study treatment.1)An acceptable method of contraception includes one of the following:
  • Abstinence from heterosexual intercourse;
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  • Hormonal contraceptives (birth control pills, injectable/implant/insertable hormonal birth control products, transdermal patch);
  • Intrauterine device (with or without hormones). 2)OR she should agree to use a double-barrier method (e.g., condom and spermicide) during the study and for at least 3 months after administration of the study treatment.
  • (2)If a subject is a female of non-childbearing potential - she 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).
  • A male study 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 90 days after administration of the study treatment.
  • Subjects understand the risks of the study, can comply with the study protocol, and complete the study.

Who cannot join

  • History of cardiovascular, respiratory, kidney, liver, metabolic, endocrine, gastrointestinal, blood, neurological, skin, psychiatric, cancer, or other major serious diseases that in the judgment of the Investigator might put the subject at risk on this study.
  • History of tuberculosis (active or latent) irrespective of treatment status or infection within the past 4 weeks or history of recurrent infections.
  • History of or current active autoimmune disease or immunodeficiency disease.
  • Subjects who have a history of clinically significant drug allergy or atopic allergic disease or known allergic reaction or hypersensitivity to the study treatment or its excipients according to the judgment of the Investigator.
  • Subjects who have a history of drug abuse in the 12 months before screening or who have a positive urine drug tests at the time of screening.
  • Subjects who have taken biologic agents within 3 months or 5 times the half-life (whichever is longer) before screening, or who have taken drugs that may affect immune function within 6 months or 5 times the half-life (whichever is longer) before screening, or over-the-counter (OTC) medications (including herbal medicines such as St John's Wort, homoeopathic preparations, vitamins, and minerals) within 7 days prior to IMP administration.
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  • 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.
  • Blood donation (excluding plasma donation) of approximately 500 mL within 56days before screening or plasma donation within 7 days before screening.
  • Those 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 (1can) of regular-strength (5%) beer; 150 mL or 5 oz wine; 45 mL or 1.5 oz liquor/spirits (40%) or who are positive for alcohol tests during the screening period.
  • Female subjects who are breastfeeding or pregnant or who have positive serum pregnancy test during the screening period and on admission.
  • Subjects who have difficulty in venous blood collection or who exhibits risk of fainting after blood collections or with the site of needles.
  • Human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody test results are positive during the screening period.
  • Any acute or chronic condition that, in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in this clinical study.
  • 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 inactivated vaccines 28 days prior to the IMP administration or plan to receive inactivated vaccines within 2 months after the end of the 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 Phase I, Randomized, Double-blind, Placebo-controlled, Single-ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of STSA-1005 Following Intravenous Infusion in Healthy Subjects

This was a single ascending dose, randomized, double-blind study assessing the safety, tolerability and pharmacokinetics of STSA-1005 in healthy participants. Four kinds different doses and dose-matched placebo were administered under fasted conditions.

Conditions
Healthy
Being tested
STSA-1005 injection, Placebo

What participants receive

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

  • STSA-1005 injectionDrug

    Intravenous injection

  • PlaceboDrug

    Intravenous injection

  • STSA-1005 injectionDrug

    Intravenous injection

  • PlaceboDrug

    Intravenous injection

  • STSA-1005 injectionDrug

    Intravenous injection

  • PlaceboDrug

    Intravenous injection

  • STSA-1005 injectionDrug

    Intravenous injection

  • PlaceboDrug

    Intravenous injection

Study groups in NCT05085197
Study groupRoleWhat they receive
Cohort 1:1mg/kgExperimentalAll participants (fasted) received either 1mg/kg of STSA-1005 as a single dose or dose-matched placebo.
Receives: Drug: STSA-1005 injection; Drug: Placebo
Cohort 2:2.5mg/kgExperimentalAll participants (fasted) received either 2.5mg/kg of STSA-1005 as a single dose or dose-matched placebo.
Receives: Drug: STSA-1005 injection; Drug: Placebo
Cohort 3:5mg/kgExperimentalAll participants (fasted) received either 5 mg/kg of STSA-1005 as a single dose or dose-matched placebo.
Receives: Drug: STSA-1005 injection; Drug: Placebo
Cohort 4:10mg/kgExperimentalAll participants (fasted) received either 10 mg/kg of STSA-1005 as a single dose or dose-matched placebo.
Receives: Drug: STSA-1005 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, Serious Adverse Events, Clinically Significant Laboratory Abnormalities, Electrocardiogram Abnormalities, Vital Signs Abnormalities and Physical Examination Abnormalities.

    Measured: Day 1 through Day 57

Secondary outcomes (13)

  1. Maximum plasma concentration (Cmax)

    To evaluate the pharmacokinetics (PK) characteristics of STSA-1005 in healthy adult subjects

    Measured: Up to 1344 hours postdose

  2. 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 pharmacokinetics (PK) characteristics of STSA-1005 in healthy adult subjects

    Measured: Up to 1344 hours postdose

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

    To evaluate the pharmacokinetics (PK) characteristics of STSA-1005 in healthy adult subjects

    Measured: Up to 1344 hours postdose

  4. Time of maximum concentration (Tmax)

    To evaluate the pharmacokinetics (PK) characteristics of STSA-1005 in healthy adult subjects

    Measured: Up to 1344 hours postdose

  5. Elimination half-life (t1/2)

    To evaluate the pharmacokinetics (PK) characteristics of STSA-1005 in healthy adult subjects

    Measured: Up to 1344 hours postdose

  6. Fraction of drug eliminated per unit of time (Kel)

    To evaluate the pharmacokinetics (PK) characteristics of STSA-1005 in healthy adult subjects

    Measured: Up to 1344 hours postdose

  7. Last measurable concentration (Clast)

    To evaluate the pharmacokinetics (PK) characteristics of STSA-1005 in healthy adult subjects

    Measured: Up to 1344 hours postdose

  8. Mean residence time (MRT)

    To evaluate the pharmacokinetics (PK) characteristics of STSA-1005 in healthy adult subjects

    Measured: Up to 1344 hours postdose

  9. Clearance (CL)

    To evaluate the pharmacokinetics (PK) characteristics of STSA-1005 in healthy adult subjects

    Measured: Up to 1344 hours postdose

  10. Apparent volume of distribution (Vz/F)

    To evaluate the pharmacokinetics (PK) characteristics of STSA-1005 in healthy adult subjects

    Measured: Up to 1344 hours postdose

  11. The number of subjects with anti-drug antibody (ADA) and neutralizing antibody (NAb)

    Measured: Up to 1344 hours postdose

  12. Change from baseline in numbers of neutrophils and monocytes

    Measured: Up to 1344 hours postdose

  13. Changes of granulocyte macrophage colony-stimulating factor (GM-CSF) receptor occupancy (RO) after the administration compared with the baseline

    Measured: Up to 1344 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 posted20 Oct 2021
  2. Study start27 Oct 2021
  3. Primary completion5 Apr 2022
  4. Study completion5 Apr 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
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05085197
Sponsor's protocol ID
STSA-1005-01
Status last verified
Oct 2021
First submitted
7 Oct 2021
Last updated
18 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-1005 injection in people with Healthy, run by Staidson Biopharma Inc. 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 11 inclusion and 14 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 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, Serious Adverse Events, Clinically Significant Laboratory Abnormalities, Electrocardiogram Abnormalities, Vital Signs Abnormalities and Physical Examination Abnormalities. (time frame: Day 1 through Day 57). 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 NCT05085197.

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 2022.

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