NCT06945445

Study of SLN12140 in Healthy Adult Participants

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose and Multiple Dose Study of SLN12140 Administered Subcutaneously or Intravenously in Healthy Adult Volunteers

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Linno Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Days – 65 Days
• Healthy volunteers: Accepted

Summary

A randomized, double-blind, placebo-controlled phase I clinical study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of SLN12140 in healthy participants with single subcutaneous/intravenous dose escalation and multiple subcutaneous administrations

Detailed description

This study will include up to 7 different dosing cohorts, with each cohort consisting of 2 groups (SLN12140 group, placebo group). Participants will be randomly assigned in a 3:1 ratio to each of these 2 groups, respectively, within all 7 cohorts, to receive either a single or multiple doses of ALXN1820 SC, a single dose of ALXN1820 IV, or a single or multiple doses of placebo. The study will be conducted in healthy adult participants .

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	SLN12140	SLN12140 for sc injection or IV infusion
OTHER	Placebo	Placebo for sc injection or IV infusion

Timeline

• Start date: 2025-04-01
• Primary completion: 2026-05-01
• Completion: 2026-06-01
• First posted: 2025-04-25
• Last updated: 2025-04-25

Locations

3 sites across 1 country: China

Regulatory

• FDA-regulated drug study