MedTrace Logo

A Study of Ralinepag in Healthy Chinese Adult Subjects

NCT04613999 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-02-01

No results posted yet for this study

Summary

A Phase 1 Open-label, Non-randomized, Single Ascending Dose Escalation Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of A Ralinepag Extended Release (XR) Tablet Formulation In Healthy Chinese Subjects.

Conditions

  • Healthy Volunteer
  • Pharmacokinetic Study

Interventions

DRUG

Ralinepag

Ralinepag will be supplied as 50 mcg round, orange, XR tablets for oral administration. It is planned that every subject will receive each of the following regimens in the fasted state: * Regimen A (50 mcg): 1 × 50 mcg ralinepag XR tablet * Regimen B (100 mcg): 2 × 50 mcg ralinepag XR tablets * Regimen C (150 mcg): 3 × 50 mcg ralinepag XR tablets Subjects will receive Regimens A, B and C in a sequential manner in consecutive treatment periods. Subjects who have tolerated the IMP in all prior regimens will continue in the study to receive each subsequent dose.

Sponsors & Collaborators

  • Everstar Medicines (Shanghai) Limited

    lead INDUSTRY

Principal Investigators

  • Haiyan Li · Peking University Third Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-09
Primary Completion
2020-11-09
Completion
2020-11-09
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04613999 on ClinicalTrials.gov