Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Trial to Evaluate the Efficacy and Safety of HRS-9813 in Subjects With Pulmonary Fibrosis

Conditions

• IPF and PPF

Eligibility Criteria

Sex

ALL

Age

21 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• HRS-9813 capsules — DRUG
  HRS-9813 capsule; High dose
• HRS-9813 capsules — DRUG
  HRS-9813 capsule; Low dose
• HRS-9813 capsule mimetic — DRUG
  HRS-9813 capsule mimetic

Study Details

To evaluate the efficacy and safety of HRS-9813 in subjects with pulmonary fibrosis。

Key Dates

First listed

Sep 25, 2025

Start date

Oct 29, 2025

Status verified

Sep 2025

Primary completion

Jun 30, 2028

Completion

Jun 30, 2028

Study Design

Enrollment

270 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Treatment group A: HRS-9813 capsules
• Experimental: Treatment group B: HRS-9813 capsules
• Placebo Comparator: Treatment group C: HRS-9813 capsule mimetic.

Primary Outcome Measure

FVC as a percentage of the predicted value [ Time Frame: The baseline period lasted until 26weeks after administration ]

Central Contacts

• Jinrui Wang
  +0518-81220121
  [email protected]

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  Not Yet Recruiting · University of California, San Francisco · San Francisco, California