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ACTIVE NOT RECRUITING
NCT07745114
PHASE1

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

Sponsor: Shenzhen Salubris Pharmaceuticals Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of SAL0137 Tablets in Healthy Participants With or Without Elevated Lp(a)

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

144

Start Date

2026-01-04

Completion Date

2026-09-30

Last Updated

2026-08-04

Healthy Volunteers

Yes

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

Locations (1)

The First Affiliated Hospital of ANHUI Medical University

Hefei, Anhui, China