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

Sponsor
Guangzhou Magpie Pharmaceuticals Co., Ltd.
Study ID
NCT05660863
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Pulmonary Arterial Hypertension

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • MN-08 24 mg/day — DRUG
    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.
  • MN-08 60 mg/day — DRUG
    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.

Study Details

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.

Key Dates

First listed
Dec 21, 2022
Start date
Sep 1, 2025
Status verified
Mar 2025
Primary completion
Mar 30, 2026
Completion
Jun 1, 2026

Study Design

Enrollment
16 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: cohort 1：MN-08 24 mg/day
    2 x 6 mg MN-08 tablets for a total dose of 12 mg or 2 matching placebo tablets (given approximately every 12 hours) for 6.5 consecutive days, until the morning dose of Day 7.
  • Experimental: cohort 2：MN-08 60 mg/day
    5 x 6 mg MN-08 tablets for a total dose of 30 mg or 5 matching placebo tablets (given approximately every 12 hours) for 6.5 consecutive days, until the morning dose of Day 7.

Primary Outcome Measure

Incidence and severity of TEAEs and SAEs [ Time Frame: Through study completion, an average of 12 days ]

Central Contacts

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