- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05986877
A Study of STSA-1201 in Healthy Subjects
April 3, 2024 updated by: Staidson (Beijing) Biopharmaceuticals Co., Ltd
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 102600
- Beijing Shijitan Hospital, Capital Medical University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: lowest dose group
8 subjects will be randomized to receive lowest dose of STSA-1201 or dose-matched placebo.
|
Subcutaneous injection
Subcutaneous injection
|
Experimental: low dose group
12 subjects will be randomized to receive low dose of STSA-1201 or dose-matched placebo.
|
Subcutaneous injection
Subcutaneous injection
|
Experimental: middle dose group
12 subjects will be randomized to receive middle dose of STSA-1201 or dose-matched placebo.
|
Subcutaneous injection
Subcutaneous injection
|
Experimental: high dose group
12 subjects will be randomized to receive high dose of STSA-1201 or dose-matched placebo.
|
Subcutaneous injection
Subcutaneous injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Day0 through Day84
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum plasma concentration (Cmax).
Time Frame: Day0 through Day84
|
To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1201 in healthy adult subjects.
|
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
|
To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1201 in healthy adult subjects.
|
Day0 through Day84
|
Area under the plasma concentration-time curve from time 0 to infinity (AUC0-∞).
Time Frame: Day0 through Day84
|
To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1201 in healthy adult subjects.
|
Day0 through Day84
|
Time of maximum concentration (Tmax).
Time Frame: Day0 through Day84
|
To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1201 in healthy adult subjects.
|
Day0 through Day84
|
Elimination half-life (t1/2).
Time Frame: Day0 through Day84
|
To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1201 in healthy adult subjects.
|
Day0 through Day84
|
Apparent clearance (CL/F).
Time Frame: Day0 through Day84
|
To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1201 in healthy adult subjects.
|
Day0 through Day84
|
Apparent volume of distribution (Vz/F).
Time Frame: Day0 through Day84
|
To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1201 in healthy adult subjects.
|
Day0 through Day84
|
Change from baseline in concentration of anti-drug antibody.
Time Frame: Day0 through Day84
|
To evaluate the immunogenicity of STSA-1201 in healthy subjects:
|
Day0 through Day84
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Xinghe Wang, MD, Beijing Shijitan Hospital, Capital Medical University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 4, 2023
Primary Completion (Actual)
March 14, 2024
Study Completion (Actual)
March 14, 2024
Study Registration Dates
First Submitted
August 3, 2023
First Submitted That Met QC Criteria
August 3, 2023
First Posted (Actual)
August 14, 2023
Study Record Updates
Last Update Posted (Actual)
April 4, 2024
Last Update Submitted That Met QC Criteria
April 3, 2024
Last Verified
August 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- STSA-1201-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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