A VSA003 Phase 1 Study in Chinese Adult Healthy Volunteers

• Sponsor: Visirna Therapeutics HK Limited (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05851066
• Collaborator: (none)
• Enrollment: 36
• Arms: 2
• Anticipated Duration (Months): 6

Study Details

Study Description

Brief Summary

This is a randomized, double blinded, phase 1 study. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single dose of VSA003 in healthy adult volunteerst

Condition or Disease	Intervention/Treatment	Phase
Dyslipidemias; Familial Hypercholesterolemia; Hypertriglyceridemia	Drug: VSA003; Drug: 0.9% NaCl	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase 1 Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of VSA003 in Chinese Adult Healthy Volunteers
• Anticipated Study Start Date: Jun 1, 2023
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: VSA003 single dose of VSA003 by subcutaneous (sc) injections: 50 mg, 100 mg, 200 mg	Drug: VSA003; sequential dosing, SC, single dose: 50 mg, 100 mg, 200 mg
Placebo Comparator: placebo sterile normal saline (0.9% NaCl) calculated volume to match active treatment	Drug: 0.9% NaCl; placebo

Outcome Measures

Primary Outcome Measures

1. Frequency and severity of adverse event (AE) and serious adverse event (SAE) [Up to 85±3 days post-dose]

   safety and tolerability

Secondary Outcome Measures

1. Maximum observed concentration (Cmax) of VSA003 [Up to 48 hours post dose]

   pharmacokinetics (PK)

2. Time of occurrence of Cmax (tmax) of VSA003 [Up to 48 hours post dose]

   PK

3. Apparent terminal phase half-life (t1/2) of VSA003 [Up to 48 hours post dose]

   PK

4. Area under the concentration-time curve from time zero (pre-dose) to the last quantifiable concentration (AUC0-t) of VSA003 [Up to 48 hours post dose]

   PK

5. Apparent clearance (CL/F) of VSA003 [Up to 48 hours post dose]

   PK

6. Apparent terminal phase volume of distribution (Vz/F) of VSA003 [Up to 48 hours post dose]

   PK

7. Change of fasting serum ANGPTL3 from pre-dose baseline [Up to 85±3 days post-dose]

   PD

8. Anti-drug Antibodies (ADA) to VSA003 [Up to 85±3 days post-dose]

   immunogenecity

Other Outcome Measures

1. Change of low density lipoprotein cholesterol (LDL-C) from pre-dose baseline [Up to 85±3 days post-dose]

   Lipid profile

2. Change of total cholesterol (TC) from pre-dose baseline [Up to 85±3 days post-dose]

   Lipid profile

3. Change of triglyceride (TG) from pre-dose baseline [Up to 85±3 days post-dose]

   Lipid profile

4. Change of high density lipoprotein cholesterol (HDL-C) from pre-dose baseline [Up to 85±3 days post-dose]

   Lipid profile

5. Change of fasting glucose from pre-dose baseline [Up to 85±3 days post-dose]

   glucose metabolism

6. Change of HbA1c from pre-dose baseline [Up to 85±3 days post-dose]

   glucose metabolism

7. Change of fasting C peptide from pre-dose baseline [Up to 85±3 days post-dose]

   glucose metabolism

8. Change of fasting insulin from pre-dose baseline [Up to 85±3 days post-dose]

   glucose metabolism

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Women of child bearing potential must have a negative pregnancy test, cannot be breastfeeding and must be willing to use contraception

• BMI 18.0~28.0 kg/m2

• Willing to provide written informed consent and to comply with study requirements

• On a stable diet for at least 4 weeks with no plans to significantly alter diet or weight over course of study

• TG> 100 mg/dL

• LDL-C> 70 mg/dL

Exclusion Criteria:

• Clinically significant health concerns

• Regular use of alcohol within one month prior to screening

• Recent (within 3 months) use of illicit drugs

• Female with pregnancy or breastfeeding

• QTcF>450 ms in ECG

• Donation or loss of whole blood more than 400 ml prior to administration of the study treatment

Note: additional inclusion/exclusion criteria may apply, per protocol

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Visirna Therapeutics HK Limited

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Visirna Therapeutics HK Limited
• ClinicalTrials.gov Identifier: NCT05851066
• Other Study ID Numbers: VSA003-1001
• First Posted: May 9, 2023
• Last Update Posted: May 11, 2023
• Last Verified: May 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia; Dyslipidemias; Hypertriglyceridemia

Study Results

No Results Posted as of May 11, 2023