NCT06670274

A Dose Escalating Study of HC002 in Healthy Adult Volunteers

A Phase 1 Randomized, Double-blind, Placebo-controlled, First-in-Human Dose Escalation Study of HC002 to Evaluate Safety, Tolerability, and Pharmacokinetics in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Holoclara Aus Pty Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a single center, randomized, double-blind, placebo-controlled, two-part study to evaluate the safety, tolerability, and PK of single (Part 1) and multiple (Part 2) oral doses of HC002. The study will enroll approximately 56 participants across 2 parts. In Part 1 (SAD), there will be 4 cohorts and in Part 2 (MAD), there will be 3 cohorts. In Part 1, a single dose of HC002 or placebo will be administered on Day 1. In Part 2, multiple doses of HC002 or placebo will be administered once daily (QD) from Day 1 to Day 7.

Conditions

• Inflammatory Disease
• Autoimmune Diseases

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-11-21
• Primary completion: 2025-03-31
• Completion: 2025-05-07
• First posted: 2024-11-01
• Last updated: 2025-05-30

Locations

1 site across 1 country: Australia