Clinical trial NCT05757596: Study of VSA001 Injection in Chinese Healthy Adult Volunteers
Official title: A Phase 1 Clinical Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Effects of a Single Dose of VSA001 Injection in Chinese Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Adult Volunteers
Lead sponsor: Visirna Therapeutics HK Limited
Sponsor class: INDUSTRY
Collaborators: name: Arrowhead Pharmaceuticals
First posted: 2023-03-07
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a phase 1, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics effects of a single dose of VSA001 injection in Chinese healthy adult volunteers. Eligible enrolled participants will initially receive VSA001 injection at the assigned dose level.


Eligibility criteria: Inclusion Criteria:

1. The subjects voluntarily participate in this study who are able to read, understand, and sign the ICF before participation; and have a full understanding of the content, process and possible adverse reactions of the study and are able to complete the study in accordance with the requirements of the protocol.
2. Healthy male and female subjects aged between 18 and 55 years (both inclusive) at the time of informed consent.
3. Body mass index (BMI) = weight (kg)/height (m)2, within the range of 19.0-30.0 kg/m2 (both inclusive), and body weight no less than 50 kg.
4. In good general health and without clinically significant abnormalities as judged by the investigator, based on medical history, physical examination, vital signs, 12-lead ECG, and laboratory results.
5. Negative serum pregnancy test within 72 h prior to initiation of study treatment in all premenopausal females and females who have been amenorrheic for less than 12 months. (Serum pregnancy test is not required for females who have undergone surgical sterilization, such as hysterectomy and/or bilateral oophorectomy, or those who have not experienced menses for 12 consecutive months and are judged to be postmenopausal based on factors such as age and castration therapy).
6. Subjects and their partners must agree to use adequate contraceptive methods prior to initiation of study treatment, during the study, and for at least 3 months after discontinuation of study treatment.
7. Fasting serum TGs \>80 mg/dL (\>0.903 mmol/L) at screening.

Exclusion Criteria:

1. History or presence of significant or clinically significant diseases/abnormality, including but not limited to cardiac/cardiovascular, respiratory, endocrine, gastrointestinal, renal, hepatic, gallbladder, dermatological, hematological, immunological, neurologic, or psychiatric diseases/abnormality, or the disease that, in the judgement of the investigator, present a safety concern or affects the pharmacokinetic evaluation.
2. A family history of congenital long QT syndrome, Brugada syndrome or unexplained sudden cardiac death.
3. Subjects who are with acute exacerbation of any significant acute or chronic disease as judged by the investigator.
4. AST and ALT \>2×upper limit of normal (ULN) , or total bilirubin \>ULN at screening.
5. Serum creatinine estimated eGFR \< 60 ml/min/1.73 m2 per MDRD formula.
6. Cardiac troponin (troponin I) above ULN at Screening.
7. Fasting serum TGs \>300 mg/dL (\>3.38 mmol/L) at screening.
8. Presence of other conditions or treatments that may affect the study results and interfere with the subject's participation in the study as assessed by the investigator.

Primary outcomes:
measure: Safety and tolerability
timeFrame: 85 days
Secondary outcomes:
measure: Pharmacokinetics parameter: Cmax
timeFrame: 48 hours
measure: Pharmacokinetics parameter: Tmax
timeFrame: 48 hours
measure: Pharmacokinetics parameter: AUC0-t
timeFrame: 48 hours
measure: Pharmacokinetics parameter: t1/2
timeFrame: 48 hours
measure: Pharmacokinetics parameter: CL/F
timeFrame: 48 hours
measure: Pharmacokinetics parameter: Vz/F
timeFrame: 48 hours
measure: Pharmacodynamic (PD) parameters
timeFrame: 85 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
References: