NCT07503015

Phase 1 Study of HS-20152 in Healthy Participants

A Randomized, Double-blind, Placebo-Controlled, Single Ascending Dose, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HS-20152 in Healthy Participants

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

This first-in-human, randomized, double-blind, placebo-controlled, single ascending dose study will evaluate the safety and tolerability of HS-20152, an investigational therapy targeting the complement pathway, in healthy adults. Secondary objectives include characterization of pharmacokinetics and pharmacodynamic effects on complement-related biomarkers.

Detailed description

HS-20152 is an investigational therapeutic designed to target a component of the complement pathway and modulate complement activity. This is a randomized, double-blinded, placebo-controlled, single ascending dose, first-in-human study of HS-20152 in healthy adult participants. Participants will be enrolled sequentially into dose cohorts and randomized within each cohort to receive a single administration of HS-20152 or placebo. Dose escalation to subsequent cohorts will proceed after protocol-defined review of safety and tolerability. The primary objective is to evaluate the safety and the tolerability of HS-20152 following single-dose administration. Secondary objectives include characterization of pharmacokinetics and assessment of pharmacodynamics effects on complement-related biomarkers. Safety assessments include adverse events, clinical laboratory tests, vital signs, physical examinations, and electrocardiograms, with follow-up through the protocol-specified observation period.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	HS-20152	HS-20152: HS-20152 will be administrated as a single dose in four sequential dose cohorts with ascending dose levels (Low, Mid, High, and an optional alternative dose cohort)
DRUG	Placebo	Placebo: Placebo matched to HS-20152 will be administrated as a single dose in each cohort, including the optional alternative dose if implemented.

Timeline

• Start date: 2026-04-22
• Primary completion: 2027-01-01
• Completion: 2027-07-01
• First posted: 2026-03-31
• Last updated: 2026-03-31

Locations

1 site across 1 country: China