MedTrace Logo

A Phase 1 Study to Evaluate the Safety and Effects of a Single Dose of HCXT-2001 Tablets and HCXT-2001 Tablets(A) in Healthy Adults.

NCT07792928 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-08-28

No results posted yet for this study

Summary

The goal of this intervention study is to assess the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of HCXT-2001 Tablets and HCXT-2001 Tablets(A) in Healthy Participants. The main parameters it aims to answer are: Does a single dose of HCXT-2001 Tablets and HCXT-2001 Tablets(A) in healthy participants impact the Safety, Tolerability, Pharmacokinetics, and Immunogenicity profiles? This study will be a - randomized, double blind, placebo-controlled study.

Conditions

Interventions

DRUG

HCXT-2001 Tablets

Two tablets taken orally in a fasted state

DRUG

Placebo

Two tablets taken orally in a fasted state

DRUG

HCXT-2001 Tablets(A)

Two tablets taken orally in a fasted state

DRUG

HCXT-2001 Tablets

One tablet taken orally in a fasted state

DRUG

Placebo

One tablet taken orally in a fasted state

DRUG

HCXT-2001 Tablets(A)

One tablet taken orally in a fasted state

Sponsors & Collaborators

  • Emerald Clinical Trials Pty Ltd

    collaborator UNKNOWN

  • Shanghai Peptidstar Therapeutics Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2026-08-14
Primary Completion
2026-11-10
Completion
2026-11-10

Countries

  • New Zealand

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 NCT07792928 on ClinicalTrials.gov