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A Phase 1 Study of PROT-001.

NCT06981299 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2026-01-30

No results posted yet for this study

Summary

A Phase 1, First-In-Human, Randomized, Double-Blind, Placebo-Controlled Multi-Part Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of PROT-001, the Effect of Food and Age on the Pharmacokinetics of PROT-001, and the Effect of PROT-001 on the Pharmacokinetics of Digoxin and Rosuvastatin in Healthy Adult Participants.

Conditions

  • Healthy

Interventions

DRUG

PROT-001

Orally bioavailable small molecule kinetic stabilizer of lambda light chains (λLCs).

DRUG

Rosuvastatin 10mg

A substrate of BCRP, OATP1B1, and OATP1B3 transporters

DRUG

Digoxin 0.25 mg

A substrate of P-gp

Sponsors & Collaborators

  • Protego Biopharma Pty Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-05-29
Primary Completion
2025-12-23
Completion
2025-12-23

Countries

  • Australia

Study Locations

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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 NCT06981299 on ClinicalTrials.gov