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SAL0137 Phase I Study in in Healthy Participants With or Without Elevated Lp(a)

NCT07745114 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2026-08-04

No results posted yet for this study

Summary

This study is divided into 3 parts: Part A, Part B, and Part C. Part A is a randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single oral doses of SAL0137 tablets; Part B is a randomized, double-blind, placebo-controlled, multiple ascending dose study with once-daily administration for 14 consecutive days to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple QD oral doses of SAL0137 tablets.

Conditions

  • Healthy Participants
  • Elevated Lp(a)

Interventions

DRUG

Single Ascending Dose

SAL0137

DRUG

Single Ascending Dose

Placebo

DRUG

Once Daily (QD), Multiple Ascending Dose (MAD)

SAL0137

DRUG

Once Daily (QD), Multiple Ascending Dose (MAD)

Placebo

Sponsors & Collaborators

  • Shenzhen Salubris Pharmaceuticals Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-01-04
Primary Completion
2026-09-30
Completion
2026-09-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07745114 on ClinicalTrials.gov