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

NCT05166837 | Completed Phase 1 DMC

• 1 other identifier: STSA-1002-02
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 5

Brief 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

Conditions

Healthy

Outcome Measures

Primary Outcomes (11)

• Incidence of Adverse Events, Clinically Significant Laboratory Abnormalities, Clinically Significant Electrocardiogram Abnormalities, Clinically Significant Vital Signs Abnormalities And Clinically Significant Physical Examination Abnormalities.

  48 days

• Maximum plasma concentration (Cmax)

  To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 in healthy adult subjects

  Up to 1152 hours postdose

• 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-1002 in healthy adult subjects

  Up to 1152 hours postdose

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

  To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 in healthy adult subjects

  Up to 1152 hours postdose

• Time of maximum concentration (Tmax)

  To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 in healthy adult subjects

  Up to 1152 hours postdose

• Elimination half-life (t1/2)

  To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 in healthy adult subjects

  Up to 1152 hours postdose

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

  To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 in healthy adult subjects

  Up to 1152 hours postdose

• Last measurable concentration (Clast)

  To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 in healthy adult subjects

  Up to 1152 hours postdose

• Mean residence time (MRT)

  To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 in healthy adult subjects

  Up to 1152 hours postdose

• Clearance (CL)

  To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 in healthy adult subjects

  Up to 1152 hours postdose

• Apparent volume of distribution (Vz)

  To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 in healthy adult subjects

  Up to 1152 hours postdose

Secondary Outcomes (2)

• Change from baseline in concentration of free C5a and anti-drug antibody

  Up to 1152 hours postdose

• Change from baseline in concentration of CH50, IL-6, IL-8,C4, TNF-α, IFN-γ

  Up to 1152 hours postdose

Study Arms (5)

Cohort 1:2mg/kg

EXPERIMENTAL

All participants (fasted) received either 2 mg/kg of STSA-1002 as a single dose or dose-matched placebo.

Drug: STSA-1002 injection; Drug: Placebo

Cohort 2:5mg/kg

EXPERIMENTAL

All participants (fasted) received either 5 mg/kg of STSA-1002 as a single dose or dose-matched placebo.

Drug: STSA-1002 injection; Drug: Placebo

Cohort 3:10mg/kg

EXPERIMENTAL

All participants (fasted) received either 10 mg/kg of STSA-1002 as a single dose or dose-matched placebo.

Drug: STSA-1002 injection; Drug: Placebo

Cohort 4:20mg/kg

EXPERIMENTAL

All participants (fasted) received either 20 mg/kg of STSA-1002 as a single dose or dose-matched placebo.

Drug: STSA-1002 injection; Drug: Placebo

Cohort 5:30mg/kg

EXPERIMENTAL

All participants (fasted) received either 30 mg/kg of STSA-1002 as a single dose or dose-matched placebo.

Drug: STSA-1002 injection; Drug: Placebo

Interventions

STSA-1002 injection DRUG

Intravenous injection

Cohort 1:2mg/kg

Placebo DRUG

Intravenous injection

Cohort 1:2mg/kg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy subjects, aged ≥ 18 but ≤ 65, male and female;
• Body mass index: 18.0 -25.0 kg/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 5 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).

You may not qualify if:

• Past history of tuberculosis, history of contact with active tuberculosis, and positive tuberculin test results;
• 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;
• There is a clear history of food or drug allergy or the total serum immunoglobulin IgE is higher than the upper limit of normal;
• Positive screening test results for human immunodeficiency virus (HIV-1/HIV-2) antibodies, hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCVAb);
• Presence of clinically significant vital signs values or of electrocardiogram (ECG) abnormalities during the screening period, as defined by an Investigator;
• ANA positive;
• During the screening period, the white blood cell count and C-reactive protein test results are abnormal and have clinical significance, hemoglobin: male \<120g/L or female \<110g/L;
• Smoking more than 5 cigarettes per day or equivalent amount of tobacco in the 3 months before screening;
• 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%);
• Subjects who had a history of drug abuse or tested positive for drugs within 1 year before screening;
• Subjects who have donated either more than approximately 500 mL of blood (exclusive plasma donation) within 3 mooth prior to screening or any plasma within 4 weeks prior to screening;
• Participate in any drug or vaccine clinical trial as a subject within 3 months before screening or prepare to be vaccinated during the study period to 2 months after the end of the study;
• Have taken drugs that may affect immune function within 6 months before screening or have received any monoclonal antibody or biological agent treatment within the previous 3 months and have taken prescription/over-the-counter drugs, herbal medicines, vitamins or other supplements within the previous 14 days;
• Drink more than 5 cups of coffee, tea or cola per day (150ml and above per cup);
• Women who are pregnant or breastfeeding;

Sponsors & Collaborators

• Staidson (Beijing) Biopharmaceuticals Co., Ltd: lead

Study Sites (5)

The second hospital of Anhui medical university

Hefei, Anhui, 230601, China

Location

Peking university People's Hospital

Beijing, Beijing Municipality, 102600, China

Location

The fifth affiliated hosipital of Guangzhou medical university

Guangzhou, Guangdong, 510799, China

Location

Peking university Shenzhen Hospital

Shenzhen, Guangdong, 518036, China

Location

The affiliated hospital of Guizhou medical university

Guiyang, Guizhou, 550004, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: December 22, 2021
• Study Start: January 10, 2022
• Primary Completion: January 12, 2023
• Study Completion: January 12, 2023
• Last Updated: December 20, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)