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A Dose Escalating Study of HC002 in Healthy Adult Volunteers

NCT06670274 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2025-05-30

No results posted yet for this study

Summary

This is a first-in-human (FIH) study to evaluate the safety, tolerability, and pharmacokinetics (PK) of single and multiple ascending oral doses of HC002 in healthy adult participants.

Conditions

Interventions

DRUG

HC002 SAD

Part 1 will enroll 32 participants across 4 cohorts. Route of administration: Oral Dose interval and frequency: Single oral dose range across 4 cohorts.

DRUG

HC002 MAD

Part 2 will enroll 24 participants across 3 cohorts. Route of administration: Oral Dose interval and frequency: Once daily for 7 days

DRUG

Placebo

Matching placebo will be administered across SAD and MAD

Sponsors & Collaborators

  • Holoclara Aus Pty Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2024-11-21
Primary Completion
2025-03-31
Completion
2025-05-07

Countries

  • Australia

Study Locations

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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 NCT06670274 on ClinicalTrials.gov