A Clinical Study to Evaluate Safety, Tolerability and Pharmacokinetics of SV001 in Chinese Healthy Adult Volunteers.

Sponsor
Shanghai Synvida Biotechnology Co.,Ltd.
Study ID
NCT06267183
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Idiopathic Pulmonary Fibrosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • SV001 — DRUG
    SV001 ： single-dose
  • Placebo — DRUG
    Placebo ： single-dose

Study Details

The purpose of this study is to evaluate safety, tolerability, PK and immunogenicity of SV001 compare to placebo in Chinese healthy adult volunteers.

Key Dates

First listed
Feb 20, 2024
Start date
Jan 12, 2024
Status verified
Apr 2025
Primary completion
Nov 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
53 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SV001
  • Placebo Comparator: Placebo

Primary Outcome Measure

Incidence of Treatment-Emergent Adverse Events [ Time Frame: Approximately 1 years ]

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