MedTrace Logo

Safety, Tolerability, and Pharmacokinetics of HSK21542 in Healthy Volunteers

NCT04110886 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2021-02-09

No results posted yet for this study

Summary

This is a A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending-Dose Study To Investigate the Safety, Tolerability, and Pharmacokinetics of a kappa receptor agonist HSK21542 in Healthy Volunteers.

The study will enroll approximately 50 adults. The anticipated study duration will be up to 6 months.

Conditions

Interventions

DRUG

HSK21542

Single dose, injection, starting dose of 0.2ug escalating up to 20ug

DRUG

Placebo

Single dose, injection matching placebo

Sponsors & Collaborators

  • Sichuan Haisco Pharmaceutical Group Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Paul Wabnitz, PhD · CMAX Clinical Research Pty Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-07-02
Primary Completion
2020-12-08
Completion
2021-01-05

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT04110886 on ClinicalTrials.gov