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
Overview
- Phase
- Phase 1
- Intervention
- Placebo
- Conditions
- Healthy
- Sponsor
- Staidson (Beijing) Biopharmaceuticals Co., Ltd
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Incidence of Adverse Events, Clinically Significant Laboratory Abnormalities, Clinically Significant Electrocardiogram、Vital Signs And Physical Examination Abnormalities.
- Status
- Completed
- Last Updated
- last year
Overview
Brief 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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
high dose group
12 subjects will be randomized to receive high dose of STSA-1201 or dose-matched placebo.
Intervention: Placebo
lowest dose group
8 subjects will be randomized to receive lowest dose of STSA-1201 or dose-matched placebo.
Intervention: STSA-1201 Subcutaneous injection
lowest dose group
8 subjects will be randomized to receive lowest dose of STSA-1201 or dose-matched placebo.
Intervention: Placebo
low dose group
12 subjects will be randomized to receive low dose of STSA-1201 or dose-matched placebo.
Intervention: STSA-1201 Subcutaneous injection
low dose group
12 subjects will be randomized to receive low dose of STSA-1201 or dose-matched placebo.
Intervention: Placebo
middle dose group
12 subjects will be randomized to receive middle dose of STSA-1201 or dose-matched placebo.
Intervention: STSA-1201 Subcutaneous injection
middle dose group
12 subjects will be randomized to receive middle dose of STSA-1201 or dose-matched placebo.
Intervention: Placebo
high dose group
12 subjects will be randomized to receive high dose of STSA-1201 or dose-matched placebo.
Intervention: STSA-1201 Subcutaneous injection
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Apparent volume of distribution (Vz/F).(Day0 through Day84)
- Change from baseline in concentration of anti-drug antibody.(Day0 through Day84)
- Maximum plasma concentration (Cmax).(Day0 through Day84)
- Area under the plasma concentration-time curve over a dosing interval, from time 0 to time t (AUC0-t).(Day0 through Day84)
- Area under the plasma concentration-time curve from time 0 to infinity (AUC0-∞).(Day0 through Day84)
- Time of maximum concentration (Tmax).(Day0 through Day84)
- Apparent clearance (CL/F).(Day0 through Day84)
- Elimination half-life (t1/2).(Day0 through Day84)