A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of SV001 in Patients With Idiopathic Pulmonary Fibrosis

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40+
SponsorShanghai Synvida Biotechnology Co.,Ltd.

About this trial

The purpose of this study is to evaluate the safety, tolerability, PK and immunogenicity of SV001 in patients with idiopathic pulmonary fibrosis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects with a confirmed diagnosis of IPF and pulmonary function meeting the protocol-specified criteria;

Subjects must agree to use highly effective contraception during the study and for 6 months after the last administration of the study drug;

Subjucts must be able to understand the study, voluntarily provide written informed consent, and be willing and able to comply with all study-related procedures.

Disqualifiers

Subjects with a history of drug or other allergies, or those judged by the investigator to be potentially allergic to the study drugs;

Presence of any other clinically significant pulmonary diseases besides IPF at screening;

Any known contraindications to performing pulmonary function tests at screening;

Respiratory or systemic infections requiring anti-infective therapy within 1 month prior to randomization;

Trial design

Design model

Parallel

Treatments tested in this trial

  • SV001

    Drug

    SV001 : Multiple-dose

  • Placebo

    Drug

    Placebo : Multiple-dose

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: SV001Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Treatment-Emergent Adverse Events

Adverse event type, incidence, duration

Time frame
Approximately 1 years

Secondary outcomes

1

Peak Plasma Concentration (Cmax)

PK (Pharmacokinetics)

Time frame
Approximately 1 years
2

Peak time(Tmax)

PK (Pharmacokinetics)

Time frame
Approximately 1 years
3

Area under the plasma concentration versus time curve (AUC)

PK (Pharmacokinetics)

Time frame
Approximately 1 years
4

half-life(T1/2)

PK (Pharmacokinetics)

Time frame
Approximately 1 years

Other outcomes

Sponsors and contacts

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