AgingResearch.NewsJoin free

Phase 1Completed

A Phase 1 Study of PROT-001.

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.

Sponsor
Protego Biopharma Pty Ltd (Industry)
Enrolment
102 enrolled
Conditions
Healthy
Interventions
PROT-001; Rosuvastatin 10mg; Digoxin 0.25 mg
Ages
adults, older adults
Registry
NCT06981299

Full record on ClinicalTrials.gov

From the registry

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.

Primary outcomes

  • Safety Outcome Measures (Adverse Events)
  • Safety outcome measures (Vital signs: Systolic Blood Pressure)
  • Safety outcome measures (Vital signs: Heart Rate)
  • Safety outcome measures (Vital signs: Respiratory Rate)

History

  1. Last registry update

  2. Primary completion

  3. Started

  4. Registered