NCT05660863

A Multiple Dose Study to Investigate Safety, Tolerability and Pharmacokinetics of MN-08 Tablets

A Bridged Phase 1, Randomized, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Multiple Dose of MN-08 in Healthy Subjects

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Guangzhou Magpie Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This trial is a single-center, Phase 1, placebo-controlled, double-blind, multiple-dose study in two ascending dose cohorts of healthy subjects. The primary objective of the trial is to assess the safety and tolerability of multiple doses of MN-08 tablet administered for 6.5 consecutive days in healthy subjects.

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	MN-08 24 mg/day	Subjects in this cohort will receive 12 mg MN-08 tablets b.i.d. for a total daily dose of 24 mg or matching placebo for 6 consecutive days, and the last dose (12 mg) on the morning of Day 7.
DRUG	MN-08 60 mg/day	Subjects in this cohort will receive 30 mg MN-08 tablets b.i.d. for a total daily dose of 60 mg or matching placebo tablets for 6 consecutive days, and the last dose (30 mg) on the morning of Day 7.

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-03-30
• Completion: 2026-06-01
• First posted: 2022-12-21
• Last updated: 2025-03-19

Regulatory

• FDA-regulated drug study