HealthyPhase 1NCT05986877
A Study of STSA-1201 in Healthy Subjects
A Phase 1 study testing STSA-1201 Subcutaneous injection in people with Healthy, run by Staidson (Beijing) Biopharmaceuticals Co., Ltd at 1 site in China.
Trial summary
This study is a Phase Ia, randomized, double-blind, placebo-controlled, single dose, dose escalation safety, tolerability, and pharmacokinetic study of STSA-1201 injection in healthy subjects. A total of 44 healthy subjects were enrolled in four dosage groups. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- STSA-1201 Subcutaneous injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 4 Aug 2023to 14 Mar 2024
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects, male or female, aged between 18 and 50 years, inclusive.
- Male subjects must have a weight range of 50.0 kg to 75.0 kg inclusive, and female subjects must have a weight range of 45.0 kg to 75.0 kg inclusive. All subjects must have a body mass index (BMI) of 19.0 to 26.0 kg/m^2 inclusive.
- Subjects (and their partners) must abstain from sperm/egg donation and commit to using effective methods of birth control during the trial and for 6 months post-trial.
- Subjects must have a normal or clinically acceptable medical history, physical examination, laboratory test results, chest X-ray and electrocardiogram (ECG).
- Subjects must fully understand the trial procedures, potential adverse reactions, and sign the informed consent form (ICF).
Who cannot join
- Subjects with significant clinical disorders or conditions (including but not limited to gastrointestinal, rental, liver, neurological, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular diseases) and subjects with active or suspected infections (viral, fungal, or parasitic).
- Subjects who underwent major surgery within 2 months prior to screening.
- Subjects with allergic constitution (such as allergies to two or more drugs, foods, and pollen) or potential allergy to the trial product/components.
- Subjects positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), human immunodeficiency virus antibody (HIV Ab) or treponema pallidum antibody (TP Ab).
- Subjects with Ig E levels exceeding the normal upper limit.
- Subjects who have smoked more than an average of 5 cigarettes per day within the 3 months prior to screening, or who are unable to abstain from using any tobacco or nicotine-containing products during the trial.
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- Subjects with a history of alcohol abuse (more than 14 units per week: 1 unit of alcohol =360mL beer or 45mL spirits with 40% alcohol or 100mL wine) within the 6 months prior to screening, or unable to abstain during the trial, or failed alcohol breath test.
- Subjects with drug abuse history (morphine, ketamine, THC, methamphetamine, methylene-dioxymethamphetamine, cocaine) within 1 year prior to screening or those testing positive for urine drug abuse screening.
- Subjects who donated or lost > 400 mL blood within 3 months prior to screening, received blood transfusions or products within 4 weeks prior to enrollment, or plan to donate blood during the trial and 3 months post-trial.
- Subjects who participated in another clinical trial or received investigational drugs/vaccines within 3 months prior to screening.
- Subjects who received biologicals or monoclonal antibodies within 3 months prior to screening; subjects who used any medication (including prescription medications, over the counter medications and herbal medicines) within 14 days prior to screening; subjects previously treated with any drugs targeting thymic stromal lymphopoietin (TSLP).
- Subjects consuming xanthine-rich foods/beverages (such as coffee, strong tea, chocolate) or those that affect drug absorption, distribution, metabolism, and excretion within 48 hours prior to administration.
- Subjects who used long-acting estrogen or progestogen injections or implants within 6 months prior to screening or short-acting contraceptives within 30 days prior to the trial.
- Female subjects who test positive for serum human chorionic gonadotropin (HCG) or have abnormal HCG levels exceeding the normal upper limit.
- Female subjects who are pregnant or lactating.
- Subjects with venipuncture intolerance, history of transfusion issues, or blood/ needle-phobia.
- Subjects with any condition or circumstance which, in the opinion of the Investigator, may compromise the ability to provide informed consent, comply with the study protocol, potentially influence study outcomes, jeopardize their own safety, or any other situation deemed unsuitable for study participation by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Shijitan Hospital, Capital Medical University
Beijing, Beijing Municipality, 102600
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Single Ascending-Dose Phase Ia Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of STSA-1201 Injection in Healthy Subjects
This study is a Phase Ia, randomized, double-blind, placebo-controlled, single dose, dose escalation safety, tolerability, and pharmacokinetic study of STSA-1201 injection in healthy subjects. A total of 44 healthy subjects were enrolled in four dosage groups.
- Conditions
- Healthy
- Being tested
- STSA-1201 Subcutaneous injection, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STSA-1201 Subcutaneous injectionDrug
Subcutaneous injection
PlaceboDrug
Subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| lowest dose group | Experimental | 8 subjects will be randomized to receive lowest dose of STSA-1201 or dose-matched placebo. Receives: Drug: STSA-1201 Subcutaneous injection; Drug: Placebo |
| low dose group | Experimental | 12 subjects will be randomized to receive low dose of STSA-1201 or dose-matched placebo. Receives: Drug: STSA-1201 Subcutaneous injection; Drug: Placebo |
| middle dose group | Experimental | 12 subjects will be randomized to receive middle dose of STSA-1201 or dose-matched placebo. Receives: Drug: STSA-1201 Subcutaneous injection; Drug: Placebo |
| high dose group | Experimental | 12 subjects will be randomized to receive high dose of STSA-1201 or dose-matched placebo. Receives: Drug: STSA-1201 Subcutaneous injection; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events, Clinically Significant Laboratory Abnormalities, Clinically Significant Electrocardiogram、Vital Signs And Physical Examination Abnormalities.
To evaluate the safety and tolerability of single subcutaneous administration of STSA-1201 in healthy adult subjects.
Measured: Day0 through Day84
Secondary outcomes (8)
Maximum plasma concentration (Cmax).
To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1201 in healthy adult subjects.
Measured: Day0 through Day84
Area under the plasma concentration-time curve over a dosing interval, from time 0 to time t (AUC0-t).
To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1201 in healthy adult subjects.
Measured: Day0 through Day84
Area under the plasma concentration-time curve from time 0 to infinity (AUC0-∞).
To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1201 in healthy adult subjects.
Measured: Day0 through Day84
Time of maximum concentration (Tmax).
To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1201 in healthy adult subjects.
Measured: Day0 through Day84
Elimination half-life (t1/2).
To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1201 in healthy adult subjects.
Measured: Day0 through Day84
Apparent clearance (CL/F).
To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1201 in healthy adult subjects.
Measured: Day0 through Day84
Apparent volume of distribution (Vz/F).
To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1201 in healthy adult subjects.
Measured: Day0 through Day84
Change from baseline in concentration of anti-drug antibody.
To evaluate the immunogenicity of STSA-1201 in healthy subjects:
Measured: Day0 through Day84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start4 Aug 2023
- Primary completion14 Mar 2024
- Study completion14 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Staidson (Beijing) Biopharmaceuticals Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xinghe Wang, MD, Principal investigator, Beijing Shijitan Hospital, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05986877
- Sponsor's protocol ID
- STSA-1201-01
- Status last verified
- Aug 2023
- First submitted
- 3 Aug 2023
- Last updated
- 21 Jun 2024
- 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 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Single Ascending-Dose Phase Ia Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of STSA-1201 Injection in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05986877
- Acronym / sponsor ID
- STSA-1201-01
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Staidson (Beijing) Biopharmaceuticals Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 4 Aug 2023 (actual)
- Primary completion
- 14 Mar 2024 (actual)
- Study completion
- 14 Mar 2024 (actual)
- First posted
- 14 Aug 2023 (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, randomized, double-blind, placebo-controlled, single dose, dose escalation safety, tolerability, and pharmacokinetic study of STSA-1201 injection in healthy subjects. A total of 44 healthy subjects were enrolled in four dosage groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| lowest dose group | Experimental | Drug: STSA-1201 Subcutaneous injection, Drug: Placebo8 subjects will be randomized to receive lowest dose of STSA-1201 or dose-matched placebo. |
| low dose group | Experimental | Drug: STSA-1201 Subcutaneous injection, Drug: Placebo12 subjects will be randomized to receive low dose of STSA-1201 or dose-matched placebo. |
| middle dose group | Experimental | Drug: STSA-1201 Subcutaneous injection, Drug: Placebo12 subjects will be randomized to receive middle dose of STSA-1201 or dose-matched placebo. |
| high dose group | Experimental | Drug: STSA-1201 Subcutaneous injection, Drug: Placebo12 subjects will be randomized to receive high dose of STSA-1201 or dose-matched placebo. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy subjects, male or female, aged between 18 and 50 years, inclusive.
- Male subjects must have a weight range of 50.0 kg to 75.0 kg inclusive, and female subjects must have a weight range of 45.0 kg to 75.0 kg inclusive. All subjects must have a body mass index (BMI) of 19.0 to 26.0 kg/m^2 inclusive.
- Subjects (and their partners) must abstain from sperm/egg donation and commit to using effective methods of birth control during the trial and for 6 months post-trial.
- Subjects must have a normal or clinically acceptable medical history, physical examination, laboratory test results, chest X-ray and electrocardiogram (ECG).
- Subjects must fully understand the trial procedures, potential adverse reactions, and sign the informed consent form (ICF).
Key exclusion criteria (17 listed)
- Subjects with significant clinical disorders or conditions (including but not limited to gastrointestinal, rental, liver, neurological, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular diseases) and subjects with active or suspected infections (viral, fungal, or parasitic).
- Subjects who underwent major surgery within 2 months prior to screening.
- Subjects with allergic constitution (such as allergies to two or more drugs, foods, and pollen) or potential allergy to the trial product/components.
- Subjects positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), human immunodeficiency virus antibody (HIV Ab) or treponema pallidum antibody (TP Ab).
- Subjects with Ig E levels exceeding the normal upper limit.
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 |
|---|---|---|
| STSA-1201 Subcutaneous injectionSubcutaneous injection | Drug | high dose group, low dose group, lowest dose group, middle dose group |
| PlaceboSubcutaneous injection | Drug | high dose group, low dose group, lowest dose group, middle dose group |
Primary outcome
Incidence of Adverse Events, Clinically Significant Laboratory Abnormalities, Clinically Significant Electrocardiogram、Vital Signs And Physical Examination Abnormalities.
Time frame: Day0 through Day84
To evaluate the safety and tolerability of single subcutaneous administration of STSA-1201 in healthy adult subjects.
8 secondary outcomes
Maximum plasma concentration (Cmax).
Time frame: Day0 through Day84
Area under the plasma concentration-time curve over a dosing interval, from time 0 to time t (AUC0-t).
Time frame: Day0 through Day84
Area under the plasma concentration-time curve from time 0 to infinity (AUC0-∞).
Time frame: Day0 through Day84
Time of maximum concentration (Tmax).
Time frame: Day0 through Day84
Elimination half-life (t1/2).
Time frame: Day0 through Day84
Apparent clearance (CL/F).
Time frame: Day0 through Day84
Apparent volume of distribution (Vz/F).
Time frame: Day0 through Day84
Change from baseline in concentration of anti-drug antibody.
Time frame: Day0 through Day84
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
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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. This study is not recruiting at the moment.
Xinghe Wang, MD principal investigator
Beijing Shijitan Hospital, Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing STSA-1201 Subcutaneous injection in people with Healthy, run by Staidson (Beijing) Biopharmaceuticals Co., Ltd at 1 site 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 17 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 21 Jun 2024. 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 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: Day0 through Day84). 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 21 Jun 2024.